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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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Lung cancer kills 160,000 patients annually; this represents 28% of all US cancer deaths. The overall year survival rate has only improved from 12% to 17% in 33 years. This failure reflects the innate lethality of lung cancer, but also reflects defects in patient care delivery. Care for the lung cancer patient starts with an abnormal radiologic scan, proceeds through a diagnostic biopsy, tests to determine the extent of spread of the disease (stage), selection of appropriate treatment, and finally ends with patient outcomes. At each step are multiple options and independent specialists, each one engaged by a process of sequential referrals in the serial care model. This process is often not user-friendly, is riddled with inefficiency, delays, and outcome variances.
The coordinated multidisciplinary model, in which patients and their doctors collaborate to provide evidence-based care, is believed by experts to be superior, but has few examples of successful implementation. The implementation gap exists because of the paucity of good quality data, and lack of implementation know-how.
Embedded in the highest US lung cancer mortality zone, the greater Memphis area has a racially, culturally, economically and geographically diverse population. The investigators research group has shown how poor quality care impairs patient survival in this region and in the greater US. The investigators have linked patient survival to compliance with multidisciplinary care plans. In this project, the investigators propose to rigorously test the impact of the multidisciplinary care model on patient outcomes in a community-based, private practice environment, similar to where 70% of lung cancer care is delivered in the US.
The objective of this study is to provide high-level evidence of the impact of multidisciplinary care on lung cancer patient outcomes. Multidisciplinary care is defined as a model of care in which patients, their care-givers and key specialists concurrently and directly evaluate the same patients in the presence of the patients and their informal caregivers, in order to develop evidence-based consensus care plans
Within the Baptist Memorial Health Care system, the Multidisciplinary Thoracic Oncology Program has two components: Primarily, the program is centered in a multidisciplinary clinic, wherein patients and their informal caregivers are seen by multiple specialists at a single appointment time; secondarily, the program includes a multidisciplinary conference, wherein all of the specialists potentially involved in lung cancer care discuss patients referred for presentation and make consensus recommendations for care. This study focuses primarily on the experience and outcomes of care delivered to patients evaluated in the multidisciplinary clinic. However, data from the conference will also be included in some aspects of the study. The goal is to improve the access and quality of thoracic oncologic care delivery within the Baptist Healthcare System The investigators specific aim is to perform a prospective, matched cohort comparative effectiveness study of patients receiving serial vs. multidisciplinary care, with key patient-centered endpoints (survival, stakeholder satisfaction with the care experience, timeliness and stage-appropriateness of care, quality of staging). Serial care is defined as the current system of linear, sequential, referral-based care delivery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multidisciplinary Clinic Patients | : 150 multidisciplinary clinic patients matched 1:2 with 300 serial care patients | ||
| Serial Care Patients | 150 multidisciplinary clinic patients matched 1:2 with 300 serial care patients = 450 patients Since Baptist Health Care System manages >800 new cases each year, 300 of which are expected to be seen in multidisciplinary clinic, in practice, we conservatively expect to be able to recruit 150 cases from multidisciplinary clinic and 300 matched serial care controls (1:2 match) in 18 months. | ||
| Multidisciplinary Caregivers | Consenting caregivers of consented multidisciplinary clinic patients (patients seen by multiple specialists at a single appointment time). | ||
| Serial Care Caregivers | Consenting caregivers of consented serial care patients (patients who receive the current system of linear, sequential, referral-based care delivery). | ||
| Clinical Providers | Clinical providers who referred at least 5 patients to the multidisciplinary program and consented to the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Thoroughness of Invasive Staging, Multidisciplinary (MD) vs Serial Care (SC) | Number of patients with a test that provides tissue confirmation of the stage-defining lesion. Tests include a biopsy of any identified suspicious metastatic lesion or the primary lesion in the absence of any other suspicious lesion. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
| Thoroughness of Invasive Mediastinal Staging, MD vs SC | Number of patients with a test (i.e., biopsy) that provides tissue confirmation of the presence or absence of mediastinal nodal metastasis. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
| Thoroughness of Bi-Modal Staging Practice, MD vs SC | Number of patients receiving two forms of staging tests (bi-modal staging). Bi-modal staging is defined as a CT scan plus any other type of radiologic scan or any biopsy. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
| Thoroughness of Tri-Modal Staging Practice, MD vs SC | Number of patients receiving three forms of staging tests (tri-modal staging). Tri-modal staging is defined as a CT scan plus any other type of radiologic scan plus any biopsy, or PET/CT plus any biopsy. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
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Inclusion Criteria:
- All patients who undergo care for lung cancer or an undiagnosed lung mass within the Baptist Memorial Health Care Corporation's hospitals from January 1, 2009 until the end of the defined study period will be eligible for inclusion in the data collection for this study. In addition, caregivers of patients within the same institution and within the study window, clinical care providers (doctors and nurses) who have taken care of patients within the eligible institutions during the study window.
Exclusion Criteria:
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Lung Cancer Patients coming through the Baptist health care system
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| Name | Affiliation | Role |
|---|---|---|
| Raymond Osarogiagbon | Baptist Memorial Health Care Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Memorial Hospital | Memphis | Tennessee | 38120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37451932 | Derived | Shao H, Faris NR, Ward KD, Chen W, McHugh L, Smeltzer M, Ray MA, Osarogiagbon RU. Lung Cancer Patients' and Caregivers' Satisfaction With Multidisciplinary Versus Serial Care in a Community Healthcare Setting: A Prospective Comparative-Effectiveness Cohort Study. Clin Lung Cancer. 2023 Nov;24(7):e267-e274. doi: 10.1016/j.cllc.2023.06.006. Epub 2023 Jun 20. | |
| 35609221 |
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Patient eligibility criteria: diagnosis of lung cancer within 6 weeks of screening date, an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, no previous lung cancer diagnosis, and no diagnosis of other cancers within the past 5 years. Caregivers and clinical care providers (doctors/nurses) of eligible patients also gave consent.
The recruitment process included a patient population of those receiving care and/or treatment for their lung cancer from physicians and clinics within the Baptist Cancer Center network, including sites in the Memphis metropolitan area, Oxford, Mississippi, and Jonesboro, Arkansas. Dates of recruitment were from October 2014 through May 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | Multidisciplinary Clinic Patients | For the multidisciplinary arm, patients and their informal caregivers are seen by multiple specialists at a single appointment time. |
| FG001 | Serial Care Patients | For the serial care arm, matched serial care control patients receive the current system of linear, sequential, referral-based care delivery. |
| FG002 | Multidisciplinary Caregivers | Consenting caregivers of consented multidisciplinary clinic patients (patients seen by multiple specialists at a single appointment time). |
| FG003 | Serial Care Caregivers | Consenting caregivers of consented serial care patients (patients who receive the current system of linear, sequential, referral-based care delivery). |
| FG004 | Clinical Providers | Clinical providers who referred at least 5 patients to the multidisciplinary program and consented to the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Baseline Intervention |
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| 3-month Follow up (Cumulative Counts) |
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| 6-month Follow up (Cumulative Counts) |
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Did not collect baseline information for caregivers or clinical providers since they were based on the patient information.
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| ID | Title | Description |
|---|---|---|
| BG000 | Multidisciplinary Clinic Patients | 150 multidisciplinary clinic patients and their informal caregivers are seen by multiple specialists at a single appointment time. |
| BG001 | Serial Care Patients |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Thoroughness of Invasive Staging, Multidisciplinary (MD) vs Serial Care (SC) | Number of patients with a test that provides tissue confirmation of the stage-defining lesion. Tests include a biopsy of any identified suspicious metastatic lesion or the primary lesion in the absence of any other suspicious lesion. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | All Specific Aim 3 patients (patients with histologically confirmed lung cancer (irrespective of histology) and an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0 (asymptomatic) to 2 (symptomatic but out of bed for >50% of the day)). | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
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All-cause mortality for patients included a median follow up time of at least 1.5 years, up to 6 years in total.
All-cause mortality was defined as the occurrence of death due to any cause. All-cause mortality for caregivers and clinical providers were not monitored.
Serious and Other (Not Including Serious) Adverse Events were not monitored or assessed for patients, caregivers, or clinical providers.
All-cause mortality reported is beyond the initial 6 month period noted in the participant flow table.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Multidisciplinary Clinic Patients | Patients seen and treated in the Multidisciplinary Clinic. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raymond Osarogiagbon | Baptist Cancer Center | 901-752-6131 | Raymond.Osarogiagbon@bmg.md |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2015 | Sep 13, 2018 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patient ICF | Nov 10, 2016 | Sep 13, 2018 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Care Giver ICF | Nov 10, 2016 | Sep 13, 2018 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Provider ICF | Nov 10, 2016 | Sep 13, 2018 | ICF_003.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 9, 2015 | Sep 18, 2018 | Prot_004.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Thoroughness of Invasive Staging, MD vs SC (Conference) vs SC (no Conference) | Number of patients with a test that provides tissue confirmation of the stage-defining lesion. Tests include a biopsy of any identified suspicious metastatic lesion or the primary lesion in the absence of any other suspicious lesion. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
| Thoroughness of Invasive Mediastinal Staging, MD vs SC (no Conference) vs SC (Conference) | Number of patients with a test (i.e., biopsy) that provides tissue confirmation of the presence or absence mediastinal nodal metastasis. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
| Thoroughness of Bi-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference) | Number of patients receiving two forms of staging tests (bi-modal staging). Bi-modal staging is defined as a CT scan plus any other type of radiologic scan or any biopsy. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
| Thoroughness of Tri-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference) | Number of patients receiving three forms of staging tests (tri-modal staging). Tri-modal staging is defined as a CT scan plus any other type of radiologic scan plus any biopsy, or PET/CT plus any biopsy. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
| Stage-Appropriateness Treatment Selection, MD vs SC | Number of patients for whom appropriate treatment was given, as determined by the patients' clinical stage and treatment guidelines stipulated by the National Comprehensive Cancer Network (NCCN). 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. For Stage I or II: surgery (or radiation therapy with documented contraindication to surgery or patient refusal); for Stage III: chemotherapy and radiation therapy with or without surgery; for Stage IV: systemic therapy (or palliative care with documented patient refusal or contraindication to systemic therapy). | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
| Stage-Appropriateness Treatment Selection, MD vs SC (Conference) vs SC (no Conference) | Number of patients for whom appropriate treatment was given, as determined by the patients' clinical stage and treatment guidelines stipulated by the National Comprehensive Cancer Network (NCCN). For Stage I or II: surgery (or radiation therapy with documented contraindication to surgery or patient refusal); for Stage III: chemotherapy and radiation therapy with or without surgery; for Stage IV: systemic therapy (or palliative care with documented patient refusal or contraindication to systemic therapy). This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
| Timeliness of Communication, MD vs SC(Conference) | Number of patients for whom formal, verified communication of care management decisions was made to all team members (providers inside and outside the multidisciplinary program, patients and their care-givers) within 48 hours of a care recommendation being made. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | Within 48 hours of a documented care recommendation made through the multidisciplinary thoracic oncology program |
| Concordance Rate for Initial Conference Recommendations, MD vs SC (Conference) | Number of patients for whom all recommendations made at the initial multidisciplinary conference were completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome. | From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months |
| Concordance Rate for Initial Conference Recommendation(s) With Prior Condition Met, MD vs SC (Conference) | Number of patients for whom all initial conference recommendations were completed, excluding conditional recommendations for which the prior condition was not met. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome. E.g., if a recommendation was to have a PET/CT and then a staging biopsy if the PET showed suspicious metastatic disease, the staging biopsy recommendation was excluded from the concordance measure if the PET/CT did not happen or was negative. | From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months |
| Concordance Rate for Any Conference Recommendation, MD vs SC (Conference) | Number of patients for whom any initial conference recommendation was completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome. | From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months |
| Overall Concordance Rate Using a Hierarchy of Initial Conference Recommendations, MD vs SC (Conference) | Number of patients for whom the overall initial conference recommendation was completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome. The hierarchy to rank recommendations, from highest priority to lowest, was (1) treatment, (2) staging, (3) diagnosis, (4) surveillance. If a patient had a treatment recommendation and it happened, he/she was concordant. If treatment was recommended and it did not happen, he/she was discordant. If no treatment recommendation was made, then concordance was measured by whether or not the staging recommendation was met. If no staging recommendation was made, then the diagnostic recommendation was given priority for a concordance measurement. If no diagnostic recommendation, then a surveillance recommendation was used to measure overall concordance. | From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months |
| Concordance Rate for Treatment Recommendations With Prior Recommendations Completed, MD vs SC (Conference) | Number of patients for whom the treatment recommendation made at the initial conference presentation was completed, excluding any patient for whom prior recommendations (staging, diagnosis, surveillance) were not also completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months |
| Baseline Patient Survey Response Rate, MD vs SC | Number of patients who completed a baseline patient survey | Baseline |
| 3-month Patient Survey Response Rate, MD vs SC | Number of patients who completed a 3-month survey | Within 30 days of 3 months after baseline survey administration |
| 6-Month Patient Survey Response Rate, MD vs SC | Number of patients who completed a 6-month survey | Within 30 days of 6 months after baseline survey administration |
| Patient Survey Scores at Baseline, MD vs SC | Scores from patient surveys that measure quality of life and satisfaction with care received at the time the baseline survey was taken. Overall quality of health care - satisfaction with overall quality of health care since lung cancer diagnosis; range: 0-4 (higher is better) Financial burden of care - assessment of financial burden of care; range: 3-6 (sum of 3 items, higher is worse) Treatment decision-making: Surgery/Radiation/Chemotherapy - each 1 item; satisfaction with treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Satisfaction with treatment plan - satisfaction with overall treatment plan; range: 1-5 (sum of 2 items, higher is better) Treatment decision-making: family role - satisfaction with family role in treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) (descriptions continued in 3 month survey description) | Baseline |
| Patient Survey Scores at 3 Months, MD vs SC | Scores from patient surveys that measure quality of life and satisfaction with care received at the time the 3-month survey was taken. (continued from baseline) Satisfaction with quality of care - overall satisfaction with care received from all care team members; range: 0-18 (sum of 6 items, higher is better) Satisfaction with physician communication - overall satisfaction with physician communication; range: 0-21 (sum of 7 items, higher is better) Satisfaction with nurse communication - overall satisfaction with nurse communication; range: 0-18 (sum of 6 items, higher is better) Overall team satisfaction - CAHPS satisfaction with care from team as a whole; range: 0-15 (sum of 4 items, higher is better) Physical/Social/Functional well-being - health-related quality of life relating to physical/social/functional well-being; range 0-28 (each a sum of 7 items, higher is better) (description continues in 6 month survey description) | Within 30 days of 3 months after baseline survey administration |
| Patient Survey Scores at 6 Months, MD vs SC | Scores from patient surveys that measure quality of life and satisfaction with care received at the time the 6-month survey was taken. (cont) Emotional well-being - health-related quality of life related to emotional well-being; range 0-30 (sum of 6 items, higher is better) Lung cancer specific QOL - health-related quality of life related to lung cancer diagnosis; range: 0-36 (sum of 9 items, higher is better) Total Summary Score FACTL - full survey, functional assessment of cancer therapy - lung; range: 0-136 (sum of 36 items, higher is better) Generic Score FACTG - full survey, functional assessment of cancer therapy - general; range: 0-108 (sum of 27 items, higher is better) Trial Outcome Index - health related quality of life - trial outcome index; range: 0-84 (sum of 23 items, higher is better) Depression/Anxiety - depression/anxiety measured by Hospital Anxiety and Depression Scale; range: 0-21 (sum of 7 items each, higher is worse) | Within 30 days of 6 months after baseline survey administration |
| Baseline Caregiver Survey Response Rate, MD vs SC | Number of caregivers who completed a baseline patient survey | Baseline |
| 3-month Caregiver Survey Response Rate, MD vs SC | Number of caregivers who completed a 3-month survey | Within 30 days of 3 months after baseline survey administration |
| 6-Month Caregiver Survey Response Rate, MD vs SC | Number of caregivers who completed a 6-month survey | Within 30 days of 6 months after baseline survey administration |
| Caregiver Survey Scores at Baseline, MD vs SC | Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the baseline survey was taken. Overall quality of health care - satisfaction with overall quality of health care since lung cancer diagnosis; range:0-4 (higher is better) Treatment decision-making: Surgery/Radiation/Chemotherapy - each 1 item; satisfaction with treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Treatment decision-making: family role - satisfaction with family role in treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Satisfaction with treatment plan - satisfaction with overall treatment plan; range: 0-2 (higher is better) Satisfaction patient can complete treatment plan; range: 0-2 (higher is better) (continued in 3 month survey description) | Baseline |
| Caregiver Survey Scores at 3 Months, MD vs SC | Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the 3-month survey was taken. (cont) Satisfaction with quality of care - overall satisfaction with care received from all care team members; range: 0-18 (sum of 6 items, higher is better) Satisfaction with physician communication - overall satisfaction with physician communication; range: 0-28 (sum of 7 items, higher is better) Satisfaction with nurse communication - overall satisfaction with nurse communication; range: 6-24 (sum of 6 items, higher is better) Overall team satisfaction - CAHPS satisfaction with care from team as a whole; range: 0-15 (sum of 4 items, higher is better) Depression/Anxiety - depression/anxiety measured by Hospital Anxiety and Depression Scale; range: 0-21 (sum of 7 items, higher is worse) (continued in 6 month survey description) | Within 30 days of 3 months after baseline survey administration |
| Caregiver Survey Scores at 6 Months, MD vs SC | Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the 6-month survey was taken. (cont) Physical Functioning QOL - 10 items; Physical Health Problems QOL - 4 items; Pain QOL - 2 items; General health perceptions - 5 items; Energy/fatigue QOL - 4 items; Social Functioning QOL - 2 items; Emotional health problems QOL - 3 items; Emotional well-being QOL - 5 items. All health related quality of life measures are from the SF-36 survey tool, and use a range of 0-100 mean score (higher is better). | Within 30 days of 6 months after baseline survey administration |
| Timeliness of Care, MD vs SC | Aggregate time in days from enrollment to a specific care delivery endpoint including: from initial detection of lesion to initial biopsy, from initial detection to non-invasive staging, from initial detection to invasive staging, and from initial detection to definitive treatment. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below |
| Timeliness of Care, MD vs SC (Conference) vs SC (no Conference) | Aggregate time in days from enrollment to specific care delivery endpoint including: from initial detection of lesion to initial biopsy, from initial detection to non-invasive staging, from initial detection to invasive staging, and from initial detection to definitive treatment. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below |
| Clinical Provider Survey Responses - Ease of Referring Patients to the Conference | Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care. | After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed |
| Clinical Provider Survey Responses - How Quickly my Patients Get Scheduled to be Discussed at the Conference | Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care. | After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed |
| Clinical Provider Survey Responses - The Helpfulness of the Staff in Scheduling Patients | Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care. | After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed |
| Clinical Provider Survey Responses - The Quality of Treatment Recommendations That I Received for my Patient | Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care. | After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed |
| Clinical Provider Survey Responses - How Quickly I Receive Feedback on my Patient | Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care. | After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed |
| Clinical Provider Survey Responses - The Consistency With Which my Patients Are Sent Back for Further Treatment | Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care. | After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed |
| Patient Overall Survival | Overall survival, defined as the time from cancer diagnosis to death from any cause or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals. | As measured from the time from cancer diagnosis to death or data censor, up to 6 years |
| Patient Overall Survival With SC Further Broken Down | Overall survival, defined as the time from cancer diagnosis to death from any cause or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | As measured from the time from cancer diagnosis to death or data censor, up to 6 years |
| Patient Disease/Progression Free Survival | Event-free survival (EFS), as measured from the time from cancer diagnosis to disease progression, death, or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals. | measured from the time from cancer diagnosis to disease progression, death, or data censoring, up to 6 years |
| Patient Disease/Progression Free Survival With SC Further Broken Down | Event-free survival (EFS), as measured from the time from cancer diagnosis to disease progression, death, or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | As measured from the time from cancer diagnosis to death or data censor, up to 6 years |
| Smeltzer MP, Ray MA, Faris NR, Meadows-Taylor MB, Rugless F, Berryman C, Jackson B, Fehnel C, Pacheco A, McHugh L, Robbins ET, Ward KD, Klesges LM, Osarogiagbon RU. Prospective Comparative Effectiveness Trial of Multidisciplinary Lung Cancer Care Within a Community-Based Health Care System. JCO Oncol Pract. 2023 Jan;19(1):e15-e24. doi: 10.1200/OP.21.00815. Epub 2022 May 24. |
| 29535915 | Derived | Smeltzer MP, Rugless FE, Jackson BM, Berryman CL, Faris NR, Ray MA, Meadows M, Patel AA, Roark KS, Kedia SK, DeBon MM, Crossley FJ, Oliver G, McHugh LM, Hastings W, Osborne O, Osborne J, Ill T, Ill M, Jones W, Lee HK, Signore RS, Fox RC, Li J, Robbins ET, Ward KD, Klesges LM, Osarogiagbon RU. Pragmatic trial of a multidisciplinary lung cancer care model in a community healthcare setting: study design, implementation evaluation, and baseline clinical results. Transl Lung Cancer Res. 2018 Feb;7(1):88-102. doi: 10.21037/tlcr.2018.01.02. |
| Withdrawal by Subject |
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| Relocation |
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| Out of window for initial survey |
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| Lost to Follow-up |
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| Other Disease |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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300 matched serial care control patients who receive the current system of linear, sequential, referral-based care delivery.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary Insurance | Count of Participants | Participants |
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| Histology | Count of Participants | Participants |
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| ECOG | Eastern Cooperative Oncology Group performance status scale. 0: fully active, able to carry on all pre-disease performance without restriction; 1: restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3: capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4: completely disabled, cannot carry on any self-care; 5: dead. | Count of Participants | Participants |
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| Initial Stage | Initial Stage is the patient's clinical stage at initial lesion detection as determined by a radiologic scan that first showed a lesion. The staging reported uses the AJCC 7th edition Tumor/Node/Metastasis (TNM) framework for lung cancer staging. Lower staging (Stage IA) is considered a better prognosis than higher staging (Stage IV). For each stage, an earlier letter means a lower stage. Occult carcinoma means the main tumor can't be assessed. In this study, a change in clinical staging from initial to independently-calculated stage measures the impact of pre-treatment decision-making. | Count of Participants | Participants |
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| Independently Calculated Clinical Stage | Independently calculated clinical stage refers to the clinical stage immediately before the onset of first line treatment is determined. The independent calculation is performed by a trained research team member using all available pre-treatment clinical information and following the AJCC 7th edition Tumor/Node/Metastasis (TNM) guidelines for lung cancer. Lower staging (Stage 0) is considered a better prognosis than higher staging (Stage IV). Within each stage, an earlier letter means a lower stage. | Count of Participants | Participants |
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| Independently Calculated Clinical T Category | The T category measures the size and extent of the primary tumor. Lower T categories (T1 tumor 3 cm or less) are considered better prognosis than higher T categories (T4 tumor larger than 7 cm, 2+ separate tumor nodules, or growth between the lungs). Independently calculated clinical T category refers to the method by which the T category immediately before onset of first line treatment is determined. The independent calculation is performed by a trained researcher using all available pre-treatment clinical information following the AJCC 7th edition framework for lung cancer staging. | Count of Participants | Participants |
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| Independently Calculated Clinical N Category | The N category measures the degree of cancer spread to nearby lymph nodes. Lower N categories (N0 the cancer has not spread to nearby lymph nodes) are considered better prognosis than higher N categories (N2 cancer spread to lymph nodes between the lungs). Independently calculated clinical N category refers to the method by which the N category immediately before onset of first line treatment is determined. The independent calculation is performed by a trained researcher using all available pre-treatment clinical information following the AJCC 7th edition framework for lung cancer staging. | Count of Participants | Participants |
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| Independently Calculated Clinical M Category | M category refers to the spread (metastasis) of the cancer to distant sites. Lower M categories (M0 no distant spread) are considered better prognosis than higher M categories (M1b spread outside the chest to distant organs such as liver, bones, or brain). Independently calculated clinical M category refers to the method by which the M category immediately before onset of first line treatment is determined. The independent calculation is performed by a trained researcher using all available pre-treatment clinical information following the AJCC 7th edition framework for lung cancer staging. | Count of Participants | Participants |
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Patients seen and treated in the Multidisciplinary Clinic.
| OG001 | Serial Care Patients | Patients seen and treated in the standard, sequential-referral-based environment of care. |
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| Primary | Thoroughness of Invasive Mediastinal Staging, MD vs SC | Number of patients with a test (i.e., biopsy) that provides tissue confirmation of the presence or absence of mediastinal nodal metastasis. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | All Specific Aim 3 patients (patients with histologically confirmed lung cancer (irrespective of histology) and an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0 (asymptomatic) to 2 (symptomatic but out of bed for >50% of the day)). | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
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| Primary | Thoroughness of Bi-Modal Staging Practice, MD vs SC | Number of patients receiving two forms of staging tests (bi-modal staging). Bi-modal staging is defined as a CT scan plus any other type of radiologic scan or any biopsy. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | All Specific Aim 3 patients (patients with histologically confirmed lung cancer (irrespective of histology) and an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0 (asymptomatic) to 2 (symptomatic but out of bed for >50% of the day)). | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
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| Primary | Thoroughness of Tri-Modal Staging Practice, MD vs SC | Number of patients receiving three forms of staging tests (tri-modal staging). Tri-modal staging is defined as a CT scan plus any other type of radiologic scan plus any biopsy, or PET/CT plus any biopsy. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | All Specific Aim 3 patients (patients with histologically confirmed lung cancer (irrespective of histology) and an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0 (asymptomatic) to 2 (symptomatic but out of bed for >50% of the day)). | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
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| Primary | Thoroughness of Invasive Staging, MD vs SC (Conference) vs SC (no Conference) | Number of patients with a test that provides tissue confirmation of the stage-defining lesion. Tests include a biopsy of any identified suspicious metastatic lesion or the primary lesion in the absence of any other suspicious lesion. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | All Specific Aim 3 patients (patients with histologically confirmed lung cancer (irrespective of histology) and an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0 (asymptomatic) to 2 (symptomatic but out of bed for >50% of the day)). | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
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| Primary | Thoroughness of Invasive Mediastinal Staging, MD vs SC (no Conference) vs SC (Conference) | Number of patients with a test (i.e., biopsy) that provides tissue confirmation of the presence or absence mediastinal nodal metastasis. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | All Specific Aim 3 patients (patients with histologically confirmed lung cancer (irrespective of histology) and an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0 (asymptomatic) to 2 (symptomatic but out of bed for >50% of the day)). | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
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| Primary | Thoroughness of Bi-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference) | Number of patients receiving two forms of staging tests (bi-modal staging). Bi-modal staging is defined as a CT scan plus any other type of radiologic scan or any biopsy. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | All Specific Aim 3 patients (patients with histologically confirmed lung cancer (irrespective of histology) and an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0 (asymptomatic) to 2 (symptomatic but out of bed for >50% of the day)). | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
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| Primary | Thoroughness of Tri-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference) | Number of patients receiving three forms of staging tests (tri-modal staging). Tri-modal staging is defined as a CT scan plus any other type of radiologic scan plus any biopsy, or PET/CT plus any biopsy. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | All Specific Aim 3 patients (patients with histologically confirmed lung cancer (irrespective of histology) and an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) from 0 (asymptomatic) to 2 (symptomatic but out of bed for >50% of the day)). | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
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| Primary | Stage-Appropriateness Treatment Selection, MD vs SC | Number of patients for whom appropriate treatment was given, as determined by the patients' clinical stage and treatment guidelines stipulated by the National Comprehensive Cancer Network (NCCN). 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. For Stage I or II: surgery (or radiation therapy with documented contraindication to surgery or patient refusal); for Stage III: chemotherapy and radiation therapy with or without surgery; for Stage IV: systemic therapy (or palliative care with documented patient refusal or contraindication to systemic therapy). | Patients with a conference lung cancer who enrolled in the study who did not die, or leave the study before treatment, or did not refuse treatment. | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
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| Primary | Stage-Appropriateness Treatment Selection, MD vs SC (Conference) vs SC (no Conference) | Number of patients for whom appropriate treatment was given, as determined by the patients' clinical stage and treatment guidelines stipulated by the National Comprehensive Cancer Network (NCCN). For Stage I or II: surgery (or radiation therapy with documented contraindication to surgery or patient refusal); for Stage III: chemotherapy and radiation therapy with or without surgery; for Stage IV: systemic therapy (or palliative care with documented patient refusal or contraindication to systemic therapy). This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | Patients with a conference lung cancer who enrolled in the study who did not die, or leave the study before treatment, or did not refuse treatment. | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months |
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| Primary | Timeliness of Communication, MD vs SC(Conference) | Number of patients for whom formal, verified communication of care management decisions was made to all team members (providers inside and outside the multidisciplinary program, patients and their care-givers) within 48 hours of a care recommendation being made. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | Patients with a conference lung cancer who enrolled in the study who did not die, or leave the study before treatment, or did not refuse treatment. | Posted | Count of Participants | Participants | Within 48 hours of a documented care recommendation made through the multidisciplinary thoracic oncology program |
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| Primary | Concordance Rate for Initial Conference Recommendations, MD vs SC (Conference) | Number of patients for whom all recommendations made at the initial multidisciplinary conference were completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome. | Patients with a conference lung cancer who enrolled in the study who did not die, or leave the study before treatment, or did not refuse treatment. | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months |
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| Primary | Concordance Rate for Initial Conference Recommendation(s) With Prior Condition Met, MD vs SC (Conference) | Number of patients for whom all initial conference recommendations were completed, excluding conditional recommendations for which the prior condition was not met. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome. E.g., if a recommendation was to have a PET/CT and then a staging biopsy if the PET showed suspicious metastatic disease, the staging biopsy recommendation was excluded from the concordance measure if the PET/CT did not happen or was negative. | Patients with a conference lung cancer who enrolled in the study who did not die, or leave the study before treatment, or did not refuse treatment. | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months |
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| Primary | Concordance Rate for Any Conference Recommendation, MD vs SC (Conference) | Number of patients for whom any initial conference recommendation was completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome. | Patients with a conference lung cancer who enrolled in the study who did not die, or leave the study before treatment, or did not refuse treatment. | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months |
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| Primary | Overall Concordance Rate Using a Hierarchy of Initial Conference Recommendations, MD vs SC (Conference) | Number of patients for whom the overall initial conference recommendation was completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome. The hierarchy to rank recommendations, from highest priority to lowest, was (1) treatment, (2) staging, (3) diagnosis, (4) surveillance. If a patient had a treatment recommendation and it happened, he/she was concordant. If treatment was recommended and it did not happen, he/she was discordant. If no treatment recommendation was made, then concordance was measured by whether or not the staging recommendation was met. If no staging recommendation was made, then the diagnostic recommendation was given priority for a concordance measurement. If no diagnostic recommendation, then a surveillance recommendation was used to measure overall concordance. | Patients with a conference lung cancer who enrolled in the study who did not die, or leave the study before treatment, or did not refuse treatment. | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months |
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| Primary | Concordance Rate for Treatment Recommendations With Prior Recommendations Completed, MD vs SC (Conference) | Number of patients for whom the treatment recommendation made at the initial conference presentation was completed, excluding any patient for whom prior recommendations (staging, diagnosis, surveillance) were not also completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | Patients with a conference lung cancer who enrolled in the study who did not die, or leave the study before treatment, or did not refuse treatment excluding any patient for whom prior recommendations (staging, diagnosis, surveillance) were not also completed. | Posted | Count of Participants | Participants | From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months |
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| Primary | Baseline Patient Survey Response Rate, MD vs SC | Number of patients who completed a baseline patient survey | Patients who were offered baseline surveys (all Specific Aim 3 patients) | Posted | Count of Participants | Participants | Baseline |
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| Primary | 3-month Patient Survey Response Rate, MD vs SC | Number of patients who completed a 3-month survey | Patients who were offered 3-month surveys. | Posted | Count of Participants | Participants | Within 30 days of 3 months after baseline survey administration |
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| Primary | 6-Month Patient Survey Response Rate, MD vs SC | Number of patients who completed a 6-month survey | Patients who were offered 6-month surveys. Note that patients were offered a 6-month survey even if they did not complete a 3-month survey. | Posted | Count of Participants | Participants | Within 30 days of 6 months after baseline survey administration |
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| Primary | Patient Survey Scores at Baseline, MD vs SC | Scores from patient surveys that measure quality of life and satisfaction with care received at the time the baseline survey was taken. Overall quality of health care - satisfaction with overall quality of health care since lung cancer diagnosis; range: 0-4 (higher is better) Financial burden of care - assessment of financial burden of care; range: 3-6 (sum of 3 items, higher is worse) Treatment decision-making: Surgery/Radiation/Chemotherapy - each 1 item; satisfaction with treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Satisfaction with treatment plan - satisfaction with overall treatment plan; range: 1-5 (sum of 2 items, higher is better) Treatment decision-making: family role - satisfaction with family role in treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) (descriptions continued in 3 month survey description) | Patients who completed baseline surveys. | Posted | Mean | Standard Error | scores on a scale | Baseline |
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| Primary | Patient Survey Scores at 3 Months, MD vs SC | Scores from patient surveys that measure quality of life and satisfaction with care received at the time the 3-month survey was taken. (continued from baseline) Satisfaction with quality of care - overall satisfaction with care received from all care team members; range: 0-18 (sum of 6 items, higher is better) Satisfaction with physician communication - overall satisfaction with physician communication; range: 0-21 (sum of 7 items, higher is better) Satisfaction with nurse communication - overall satisfaction with nurse communication; range: 0-18 (sum of 6 items, higher is better) Overall team satisfaction - CAHPS satisfaction with care from team as a whole; range: 0-15 (sum of 4 items, higher is better) Physical/Social/Functional well-being - health-related quality of life relating to physical/social/functional well-being; range 0-28 (each a sum of 7 items, higher is better) (description continues in 6 month survey description) | Patients who completed 3-month surveys. | Posted | Mean | Standard Error | scores on a scale | Within 30 days of 3 months after baseline survey administration |
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| Primary | Patient Survey Scores at 6 Months, MD vs SC | Scores from patient surveys that measure quality of life and satisfaction with care received at the time the 6-month survey was taken. (cont) Emotional well-being - health-related quality of life related to emotional well-being; range 0-30 (sum of 6 items, higher is better) Lung cancer specific QOL - health-related quality of life related to lung cancer diagnosis; range: 0-36 (sum of 9 items, higher is better) Total Summary Score FACTL - full survey, functional assessment of cancer therapy - lung; range: 0-136 (sum of 36 items, higher is better) Generic Score FACTG - full survey, functional assessment of cancer therapy - general; range: 0-108 (sum of 27 items, higher is better) Trial Outcome Index - health related quality of life - trial outcome index; range: 0-84 (sum of 23 items, higher is better) Depression/Anxiety - depression/anxiety measured by Hospital Anxiety and Depression Scale; range: 0-21 (sum of 7 items each, higher is worse) | Patients who completed 6-month surveys. | Posted | Mean | Standard Error | scores on a scale | Within 30 days of 6 months after baseline survey administration |
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| Primary | Baseline Caregiver Survey Response Rate, MD vs SC | Number of caregivers who completed a baseline patient survey | Caregivers who completed surveys | Posted | Count of Participants | Participants | Baseline |
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| Primary | 3-month Caregiver Survey Response Rate, MD vs SC | Number of caregivers who completed a 3-month survey | Caregivers who completed surveys | Posted | Count of Participants | Participants | Within 30 days of 3 months after baseline survey administration |
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| Primary | 6-Month Caregiver Survey Response Rate, MD vs SC | Number of caregivers who completed a 6-month survey | Caregivers who completed surveys | Posted | Count of Participants | Participants | Within 30 days of 6 months after baseline survey administration |
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| Primary | Caregiver Survey Scores at Baseline, MD vs SC | Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the baseline survey was taken. Overall quality of health care - satisfaction with overall quality of health care since lung cancer diagnosis; range:0-4 (higher is better) Treatment decision-making: Surgery/Radiation/Chemotherapy - each 1 item; satisfaction with treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Treatment decision-making: family role - satisfaction with family role in treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Satisfaction with treatment plan - satisfaction with overall treatment plan; range: 0-2 (higher is better) Satisfaction patient can complete treatment plan; range: 0-2 (higher is better) (continued in 3 month survey description) | Posted | Mean | Standard Error | scores on a scale | Baseline |
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| Primary | Caregiver Survey Scores at 3 Months, MD vs SC | Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the 3-month survey was taken. (cont) Satisfaction with quality of care - overall satisfaction with care received from all care team members; range: 0-18 (sum of 6 items, higher is better) Satisfaction with physician communication - overall satisfaction with physician communication; range: 0-28 (sum of 7 items, higher is better) Satisfaction with nurse communication - overall satisfaction with nurse communication; range: 6-24 (sum of 6 items, higher is better) Overall team satisfaction - CAHPS satisfaction with care from team as a whole; range: 0-15 (sum of 4 items, higher is better) Depression/Anxiety - depression/anxiety measured by Hospital Anxiety and Depression Scale; range: 0-21 (sum of 7 items, higher is worse) (continued in 6 month survey description) | Posted | Mean | Standard Error | scores on a scale | Within 30 days of 3 months after baseline survey administration |
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| Primary | Caregiver Survey Scores at 6 Months, MD vs SC | Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the 6-month survey was taken. (cont) Physical Functioning QOL - 10 items; Physical Health Problems QOL - 4 items; Pain QOL - 2 items; General health perceptions - 5 items; Energy/fatigue QOL - 4 items; Social Functioning QOL - 2 items; Emotional health problems QOL - 3 items; Emotional well-being QOL - 5 items. All health related quality of life measures are from the SF-36 survey tool, and use a range of 0-100 mean score (higher is better). | Posted | Mean | Standard Error | scores on a scale | Within 30 days of 6 months after baseline survey administration |
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| Primary | Timeliness of Care, MD vs SC | Aggregate time in days from enrollment to a specific care delivery endpoint including: from initial detection of lesion to initial biopsy, from initial detection to non-invasive staging, from initial detection to invasive staging, and from initial detection to definitive treatment. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. | Not every patient went to every step, therefore the times only include patients that completed that step. | Posted | Median | Inter-Quartile Range | Days | From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below |
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| Primary | Timeliness of Care, MD vs SC (Conference) vs SC (no Conference) | Aggregate time in days from enrollment to specific care delivery endpoint including: from initial detection of lesion to initial biopsy, from initial detection to non-invasive staging, from initial detection to invasive staging, and from initial detection to definitive treatment. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | Not every patient went to every step, therefore the times only include patients that completed that step. | Posted | Median | Inter-Quartile Range | Days | From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below |
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| Primary | Clinical Provider Survey Responses - Ease of Referring Patients to the Conference | Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care. | Any clinical provider who referred at least 5 patients to the multidisciplinary program and consented to take satisfaction surveys. | Posted | Count of Participants | Participants | After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed |
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| Primary | Clinical Provider Survey Responses - How Quickly my Patients Get Scheduled to be Discussed at the Conference | Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care. | Any clinical provider who referred at least 5 patients to the multidisciplinary program and consented to take satisfaction surveys. | Posted | Count of Participants | Participants | After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed |
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| Primary | Clinical Provider Survey Responses - The Helpfulness of the Staff in Scheduling Patients | Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care. | Any clinical provider who referred at least 5 patients to the multidisciplinary program and consented to take satisfaction surveys. | Posted | Count of Participants | Participants | After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed |
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| Primary | Clinical Provider Survey Responses - The Quality of Treatment Recommendations That I Received for my Patient | Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care. | Any clinical provider who referred at least 5 patients to the multidisciplinary program and consented to take satisfaction surveys. | Posted | Count of Participants | Participants | After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed |
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| Primary | Clinical Provider Survey Responses - How Quickly I Receive Feedback on my Patient | Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care. | Any clinical provider who referred at least 5 patients to the multidisciplinary program and consented to take satisfaction surveys. | Posted | Count of Participants | Participants | After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed |
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| Primary | Clinical Provider Survey Responses - The Consistency With Which my Patients Are Sent Back for Further Treatment | Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care. | Any clinical provider who referred at least 5 patients to the multidisciplinary program and consented to take satisfaction surveys. | Posted | Count of Participants | Participants | After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed |
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| Primary | Patient Overall Survival | Overall survival, defined as the time from cancer diagnosis to death from any cause or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals. | Posted | Number | 95% Confidence Interval | survival probability | As measured from the time from cancer diagnosis to death or data censor, up to 6 years |
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| Primary | Patient Overall Survival With SC Further Broken Down | Overall survival, defined as the time from cancer diagnosis to death from any cause or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | Posted | Number | 95% Confidence Interval | survival probability | As measured from the time from cancer diagnosis to death or data censor, up to 6 years |
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| Primary | Patient Disease/Progression Free Survival | Event-free survival (EFS), as measured from the time from cancer diagnosis to disease progression, death, or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals. | Posted | Number | 95% Confidence Interval | survival probability | measured from the time from cancer diagnosis to disease progression, death, or data censoring, up to 6 years |
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| Primary | Patient Disease/Progression Free Survival With SC Further Broken Down | Event-free survival (EFS), as measured from the time from cancer diagnosis to disease progression, death, or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model. | Posted | Number | 95% Confidence Interval | survival probability | As measured from the time from cancer diagnosis to death or data censor, up to 6 years |
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| 125 |
| 178 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Serial Care Patients | Patients seen and treated in the standard, sequential-referral-based environment of care. | 239 | 348 | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Regression, Logistic | 0.0779 | Conditional logistic regression adjusted for the matched study design, sex, age, and histology. | Odds Ratio (OR) | 2.621 | 2-Sided | 95 | 1.473 | 4.665 | Odds ratio comparing Serial Care patients in conference with and without invasive staging (numerator=46/30) to Serial Care patients not in conference with and without invasive staging (denominator=122/150) after adjustment for matched study design. | Superiority |
| Regression, Logistic | 0.0631 | Conditional logistic regression adjusted for the matched study design, sex, age, and histology. | Odds Ratio (OR) | 2.535 | 2-Sided | 95 | 1.446 | 4.444 | Odds ratio comparing Serial Care patients in conference with and without mediastinal staging (numerator=40/36) to Serial Care patients not in conference with and without mediastinal staging (denominator=86/186) after adjustment for matched study. | Superiority |
| Regression, Logistic | 0.1972 | Conditional logistic regression adjusted for the matched study design, sex, age, and histology. | Odds Ratio (OR) | 1.103 | 2-Sided | 95 | 0.526 | 2.314 | Odds ratio comparing Serial Care patients in conference with and without bi-modal staging (numerator=62/14) to Serial Care patients not in conference with and without bi-modal staging (denominator=205/67) after adjustment for matched study. | Superiority |
| Regression, Logistic |
| 0.2572 |
Conditional logistic regression adjusted for the matched study design, sex, age, and histology. |
| Odds Ratio (OR) |
| 2.242 |
| 2-Sided |
| 95 |
| 1.287 |
| 3.905 |
Odds ratio comparing Serial Care patients in conference with and without tri-modal staging (numerator=39/37) to Serial Care patients not in conference with and without tri-modal staging (denominator=93/179) after adjustment for matched study. |
| Superiority |
| Regression, Logistic | 0.6353 | Conditional logistic regression adjusted for the matched study design, sex, age, and histology. | Odds Ratio (OR) | 1.751 | 2-Sided | 95 | 0.910 | 3.370 | Odds ratio comparing SC patients in conference with and without stage appropriate treatment (numerator=58/15) to SC patients not in conference with and without stage appropriate treatment (denominator=174/91) after adjustment for matched study. | Superiority |
| Treatment decision-making: Surgery |
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| Treatment decision-making: Radiation |
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| Treatment decision-making: Chemotherapy |
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| Satisfaction with treatment plan |
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| Treatment decision-making: Family role |
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| Satisfaction with quality of care |
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| Satisfaction with physician communication |
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| Satisfaction with nurse communication |
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| Overall team satisfaction |
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| Physical well-being |
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| Social well-being |
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| Functional well-being |
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| Emotional well-being |
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| Lung cancer specific QOL |
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| Total Summary Score FACTL |
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| Generic score FACTG |
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| Trial outcome index |
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| Depression |
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| Anxiety |
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| Treatment decision-making: Surgery |
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| Treatment decision-making: Radiation |
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| Treatment decision-making: Chemotherapy |
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| Satisfaction with treatment plan |
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| Treatment decision-making: Family role |
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| Satisfaction with quality of care |
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| Satisfaction with physician communication |
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| Satisfaction with nurse communication |
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| Overall team satisfaction |
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| Physical well-being |
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| Social well-being |
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| Functional well-being |
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| Emotional well-being |
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| Lung cancer specific QOL |
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| Total Summary Score FACTL |
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| Generic score FACTG |
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| Trial outcome index |
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| Depression |
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| Anxiety |
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| Treatment decision-making: Surgery |
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| Treatment decision-making: Radiation |
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| Satisfaction with treatment plan |
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| Treatment decision-making: Chemo |
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| Treatment decision-making: Family role |
|
| Satisfaction with quality of care |
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| Satisfaction with physician communication |
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| Satisfaction with nurse communication |
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| Overall team satisfaction |
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| Physical well-being |
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| Social well-being |
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| Functional well-being |
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| Emotional well-being |
|
| Lung cancer specific QOL |
|
| Total Summary Score FACTL |
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| Generic score FACTG |
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| Trial outcome index |
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| Depression |
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| Anxiety |
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| Treatment decision-making: Radiation |
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| Treatment decision-making: Chemo |
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| Treatment decision-making: Family role |
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| Satisfaction with treatment plan |
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| Satisfaction patient can complete treatment plan |
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| Satisfaction with quality of care |
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| Satisfaction with physician communication |
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| Satisfaction with nurse communication |
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| Overall team satisfaction |
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| Depression |
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| Anxiety |
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| Physical Functioning QOL |
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| Physical health problems QOL |
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| Pain QOL |
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| General health perceptions |
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| Energy/Fatigue QOL |
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| Social Functioning QOL |
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| Emotional health problems QOL |
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| Emotional well-being QOL |
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| Treatment decision-making: Radiation |
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| Treatment decision-making: Chemo |
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| Treatment decision-making: Family role |
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| Satisfaction with treatment plan |
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| Satisfaction patient can complete treatment plan |
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| Satisfaction with quality of care |
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| Satisfaction with physician communication |
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| Satisfaction with nurse communication |
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| Overall team satisfaction |
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| Depression |
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| Anxiety |
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| Physical Functioning QOL |
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| Physical health problems QOL |
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| Pain QOL |
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| General health perceptions |
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| Energy/Fatigue QOL |
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| Social Functioning QOL |
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| Emotional health problems QOL |
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| Emotional well-being QOL |
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| Treatment decision-making: Radiation |
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| Treatment decision-making: Chemo |
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| Treatment decision-making: Family role |
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| Satisfaction with treatment plan |
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| Satisfaction patient can complete treatment plan |
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| Satisfaction with quality of care |
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| Satisfaction with physician communication |
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| Satisfaction with nurse communication |
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| Overall team satisfaction |
|
| Depression |
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| Anxiety |
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| Physical Functioning QOL |
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| Physical health problems QOL |
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| Pain QOL |
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| General health perceptions |
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| Energy/Fatigue QOL |
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| Social Functioning QOL |
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| Emotional health problems QOL |
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| Emotional well-being QOL |
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| From initial detection to non-invasive staging |
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| From initial detection to invasive staging |
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| From initial detection to definitive treatment |
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| 0.0805 |
| Superiority |
| Time from Initial Detection of Lesion to Invasive Staging Test | Wilcoxon (Mann-Whitney) | 0.0073 | Superiority |
| Time from Initial Detection of Lesion to Definitive Treatment | Wilcoxon (Mann-Whitney) | 0.0579 | Superiority |
| From initial detection to non-invasive staging |
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| Initial detection of lesion to invasive staging |
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| From initial detection to definitive treatment |
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|
| Kruskal-Wallis |
| 0.16 |
| Superiority |
| Time from Initial Detection of Lesion to Invasive Staging Test | Kruskal-Wallis | 0.0014 | Superiority |
| Time from Initial Detection of Lesion to Definitive Treatment | Kruskal-Wallis | 0.0037 | Superiority |
| Somewhat satisfied |
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| Somewhat dissatisfied |
|
| Dissatisfied |
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| Very Dissatisfied |
|
| Somewhat satisfied |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Somewhat satisfied |
|
| Somewhat dissatisfied |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Somewhat satisfied |
|
| Somewhat dissatisfied |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Somewhat satisfied |
|
| Dissatisfied |
|
| Very Dissatisfied |
|
| Somewhat satisfied |
|
| Somewhat dissatisfied |
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| Dissatisfied |
|
| Very Dissatisfied |
|
| N/A |
|
| 1.08 |
| 2-Sided |
| 95 |
| 0.85 |
| 1.36 |
Comparison is Multidisciplinary/Serial Care. |
| Superiority |
| 3-year overall survival estimate |
|
| Hazard Ratio (HR) |
| 1.12 |
| 2-Sided |
| 95 |
| 0.87 |
| 1.43 |
Comparison is Multidisciplinary/Serial Care Patients Not Presented in Conference |
| Superiority |
| Regression, Cox | 0.51 | Hazard Ratio (HR) | 1.19 | 2-Sided | 95 | 0.84 | 1.67 | Comparison is Serial Care Patients Presented in Conference/Serial Care Patients Not Presented in Conference | Superiority |
| 1.03 |
| 2-Sided |
| 95 |
| 0.82 |
| 1.29 |
Comparison is Multidisciplinary/Serial Care |
| Superiority |
|
| Hazard Ratio (HR) |
| 1.06 |
| 2-Sided |
| 95 |
| 0.83 |
| 1.34 |
Comparison is Multidisciplinary/Serial Care Patients Not Presented in Conference |
| Superiority |
| Regression, Cox | 0.73 | Hazard Ratio (HR) | 1.13 | 2-Sided | 95 | 0.82 | 1.57 | Comparison is Serial Care Patients Presented in Conference/Serial Care Patients Not Presented in Conference | Superiority |