Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Pro2022-0776 | Other Identifier | Hackensack Meridian Health IRB |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Indiana University | OTHER |
| University of North Carolina | OTHER |
| Memorial Sloan Kettering Cancer Center |
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to learn about discussion between clinicians and their patients related to lung screening. Survey answers will be collected from both clinicians and their patients.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinicians | Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients |
| |
| Smokers/Former Smokers | Current smoker or former smoker who has quit within the past 15 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale) | Behavioral | Perceived Smoking-Related Stigma will be measured using the 5-item Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale). The response scale is 1 = strongly disagree, to 4 = strongly agree, and scores range from 5 to 25 (high stigma). Cronbach's alphas were 0.75 to 0.89 in prior studies. |
| Measure | Description | Time Frame |
|---|---|---|
| Key Components of Shared Decision Making Process That Predict Patient-perceived Lung Cancer Screening Decision Quality | Decisional Quality was measured using the multidimensional Decisional Conflict Scale, a 16-item Likert-response scale that was modified by the investigators for the lung cancer screening context. The total score ranging from 0 to 64. This total score is commonly transformed into a standardized score that falls within a 0 to 100 range. Decisional quality measured on this numeric scale from which lower scores represent lower decisional conflict and, therefore, higher decisional quality. Scores below 25 have been associated with low decisional conflict. | at baseline (study enrollment) |
Not provided
Not provided
Inclusion Criteria:
CLINICIANS:
PATIENTS (Quantitative Phase):
Exclusion Criteria:
PATIENTS:
Not provided
Not provided
All recruitment will take place at Kaiser Permanente Washington.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jamie Ostroff, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Lisa Carter-Bawa, PhD | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Washington Health Research Institute | Seattle | Washington | 98101-1466 | United States |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Clinicians | Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients Primary Care Clinicians' Lung Cancer Screening Survey: Includes items to assess attitudes, barriers, and knowledge of lung cancer screening guidelines. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 31, 2022 |
Not provided
| OTHER |
| Kaiser Permanente | OTHER |
Not provided
Not provided
Not provided
|
| Patient Trust in the Medical | Behavioral | Medical Mistrust will be measured using the 5-item Patient Trust in the Medical Profession Scale.80 The five-point Likert responses measure the extent to which patients perceive their clinician to be honest, caring more about convenience, thorough and careful, and trusted. The range of scores is 5 to 25 (higher mistrust). Reliability and validity have been well established with a Cronbach"s alpha of 0.84. |
|
| Decision Conflict Scale (DCS) - Lung Cancer Screening | Behavioral | The DCS is a 16-item Likert-response item scale that has been modified for the lung cancer screening and smoking cessation contexts. The DCS was developed by O"Connor,74-75 and validated in many health decisions including breast cancer screening with Cronbach"s alphas ranging from 0.78 to 0.81. 74-75 Despite its name, the DCS measures more than decision conflict to encompass personal perceptions of perceived decision-making quality such as feeling the choice is informed, values based, and likely to be implemented as well as expressing satisfaction with the decision. 74-75 The DCS is comprised of items with response options ranging from 1 (strongly disagree) to 5 (strongly agree). The items are summed to total scale score with lower scores reflective of higher decision conflict and higher scores reflective of lower decision conflict. |
|
|
| Shared Decision Making Questionnaire (SDM-Q)- Patient | Behavioral | Shared Decision Making Process will be measured from the patient perspective using the 9-item Shared Decision Making Questionnaire (SDM-Q-9),77 which has been validated with a Cronbach"s alpha of 0.94. |
|
|
| Stage of Readiness for Smoking Cessation - Contemplation Ladder | Behavioral | Among current smokers |
|
| Primary Care Clinicians' Lung Cancer Screening Survey | Behavioral | Includes items to assess attitudes, barriers, and knowledge of lung cancer screening guidelines. |
|
| Smokers/Former Smokers |
Current smoker or former smoker who has quit within the past 15 years |
| COMPLETED |
|
| NOT COMPLETED |
|
Clinicians and patients included in the study
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Clinicians | Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients |
| BG001 | Smokers/Former Smokers | Current smoker or former smoker who has quit within the past 15 years |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Clinicians who participated in the study were only asked for their age as a categorical variable as a result we cannot provide mean and standard deviation. | Mean | Standard Deviation | years |
| ||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Key Components of Shared Decision Making Process That Predict Patient-perceived Lung Cancer Screening Decision Quality | Decisional Quality was measured using the multidimensional Decisional Conflict Scale, a 16-item Likert-response scale that was modified by the investigators for the lung cancer screening context. The total score ranging from 0 to 64. This total score is commonly transformed into a standardized score that falls within a 0 to 100 range. Decisional quality measured on this numeric scale from which lower scores represent lower decisional conflict and, therefore, higher decisional quality. Scores below 25 have been associated with low decisional conflict. | Posted | Mean | Standard Deviation | score on a scale | at baseline (study enrollment) |
|
|
|
Within 12 months
Self reported adverse events
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinicians | Primary care clinicians (general internists, family physicians, nurse practitioners, physician assistants) who treat lung cancer screening eligible patients | 0 | 125 | 0 | 125 | 0 | 125 |
| EG001 | Smokers/Former Smokers | Current smoker or former smoker who has quit within the past 15 years | 0 | 529 | 0 | 529 | 0 | 529 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lisa Carter-Bawa, PhD, MPH, APRN, ANP-C, FAAN | Hackensack Meridian Health | 2018803443 | lisa.carterbawa@hmh-cdi.org |
| Jun 11, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D000073869 | Tobacco Smoking |
| D000073865 | Cigarette Smoking |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D064424 | Tobacco Use |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003523 | Cycloserine |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D023303 | Oxazolidinones |
| D010080 | Oxazoles |
| D012694 | Serine |
| D021542 | Amino Acids, Neutral |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
Not provided
Not provided
|
| ≥ 18 and ≤ 50 years |
|
|
| > 50 years |
|
|
|
| Male |
|
|
| Prefer not to say |
|
|
|
|
|