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| ID | Type | Description | Link |
|---|---|---|---|
| 00046658 | |||
| LCI-GI-NOS-NAV-001 | Other Identifier | Atrium |
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The purpose of this study is to learn about the impact of the Oncology Nurse Navigation program on the frequency of Emergency Department, urgent care visits and inpatient hospital admissions; and overall survival rate at 6 months. The investigators aim to understand if prompt and effective coordination of care provided by Oncology Nurse Navigation (ONN) service will reduce the number of avoidable, unplanned ED visits and hospitalizations, as well as adding measurable value to cancer care, and improve patient overall survival.
A randomized controlled prospective trial evaluating the effectiveness of a nurse navigation program for gastrointestinal cancer patients undergoing oncological treatment. Upon accrual, patients will be randomized 1:1 to receive standard of care plus ONN service (n = 107) or standard of care only (without ONN service; n = 107). Patients in both arms will be assessed for acute care utilization and overall survival (OS) rate at 6 months. Anticipated accrual period will be 30 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | No Intervention | Standard of Care | |
| Oncology Nurse Navigation | Experimental | Standard of Care + Oncology Nurse Navigation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oncology Nurse Navigation | Other | Providing the subject with the service of navigation (ONN) performed under LCI Patient Navigation Program (LPNP), led by a registered oncology nurse. |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Count of Acute Care Visits | The annualized count of acute care visits, where acute care visits included all unplanned inpatient admissions, emergency room encounters, and/or urgent care visits, was calculated for each subject as the total number of acute care visits normalized to an annual basis. | From the date of randomization until subject discontinued the intervention, assessed up to 34 months |
| Proportion of Participants Surviving at 6 Months | The proportion of participants surviving at 6 months was calculated for each treatment arm. Six-month overall survival was determined for each subject as a binary variable indicating whether or not the subject was alive at 6 months after study enrollment. Failure occurred if the subject died from any cause within 6 months of study enrollment. The proportions were compared between the arms. | From the date of randomization to death or 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Surviving at 12 Months | The proportion of participants surviving at 12 months was calculated for each treatment arm. Six-month overall survival was determined for each subject as a binary variable indicating whether or not the subject was alive at 12 months after study enrollment. Failure occurred if the subject died from any cause within 12 months of study enrollment. The proportions were compared between the arms. |
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Inclusion Criteria
Informed consent and HIPAA authorization for the release of personal health information
Aged ≥ 18 years at the time of consent
Subject is planning to receive their cancer care at LCI at the time of consent
Treatment naïve OR adjuvant greater than 6 months ago, histologically or cytologically confirmed one of the following diagnoses (metastatic/recurrent status can be radiologically confirmed):
Metastatic/recurrent or locally advanced, unresectable or borderline resectable (as defined per NCCN, Alliance or other acceptable guidelines criteria) pancreatic cancer
Metastatic/recurrent or locally advanced, unresectable esophageal, gastroesophageal junction (GEJ) or gastric cancer patients or those who are not eligible for surgery
Metastatic/recurrent or locally advanced, unresectable hepatocellular carcinoma (HCC)
Metastatic/recurrent or advanced, unresectable biliary cancers (e.g. gall bladder cancer, cholangiocarcinoma)
• prior locoregional treatment for subjects with biliary cancers is allowed, but no prior systemic therapy is allowed
Metastatic colorectal or small bowel cancer patients who had disease progression on or are intolerant to fluorouracil/capecitabine, oxaliplatin, and irinotecan-based therapy (e.g. FOLFOX, FOLFIRI or FOLFOXIRI)
Ability to read and understand the English or Spanish language
As determined by the enrolling physician, ability of the subject to understand and comply with study procedures for the entire length of the study. However, refusal to complete a patient satisfaction questionnaire IL109 should not refrain a subject from being enrolled.
Life expectancy is > 3 months
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Salem, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Standard of Care |
| FG001 | Oncology Nurse Navigation | Standard of Care + Oncology Nurse Navigation Oncology Nurse Navigation: Providing the subject with the service of navigation (ONN) performed under LCI Patient Navigation Program (LPNP), led by a registered oncology nurse. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All randomized participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Standard of Care |
| BG001 | Oncology Nurse Navigation | Standard of Care + Oncology Nurse Navigation Oncology Nurse Navigation: Providing the subject with the service of navigation (ONN) performed under LCI Patient Navigation Program (LPNP), led by a registered oncology nurse. |
| 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 | Annualized Count of Acute Care Visits | The annualized count of acute care visits, where acute care visits included all unplanned inpatient admissions, emergency room encounters, and/or urgent care visits, was calculated for each subject as the total number of acute care visits normalized to an annual basis. | Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date and (b) died within six months of enrollment or otherwise were on study for at least 6 months. | Posted | Median | Inter-Quartile Range | unplanned acute care visits in one year | From the date of randomization until subject discontinued the intervention, assessed up to 34 months |
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From the date of randomization until subject discontinued study involvement, assessed up to 34 months
The number of participants who died while on study is summarized. Other adverse events were not collected for study purposes as the intervention was unlikely to present harm to enrolled participants above standard of care.
The number of participants at risk for Serious Adverse Events is zero because adverse events were not monitored/assessed.
The number of participants at risk for Other (Not Including Serious) Adverse Events is zero because adverse events were not monitored/assessed.
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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 | Standard of Care | Standard of Care | 72 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Danielle M Boselli | Wake Forest | 2017903385 | Danielle.Boselli@AtriumHealth.org |
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| 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 | Apr 11, 2023 | Oct 29, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2023 | Sep 26, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| From the date of randomization up until 12 months |
| Hospital Length of Stay | Hospital length of stay was calculated for each subject as the total number of unplanned inpatient days while on intervention. | From the date of randomization until subject discontinued the intervention, assessed up to 34 months |
| Time From Hospice Referral to Death for Participants Referred to Hospice | Time from hospice referral to death was a time-to-event endpoint defined as the time from hospice referral to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive. This endpoint was only calculated for subjects referred to hospice. | From the date of hospice referral to death or last follow-up, assessed over 7 months. |
| Total Number of 30-day Readmissions | The number of readmissions within 30 days of in-patient admission discharges was calculated for each participant. This outcome was derived for each subject with at least one in-patient admission. | From the date of randomization until subject discontinued the intervention, assessed up to 34 months |
| Proportion of Participants Referred to Supportive Care Services | Referral to Supportive Care Services was derived for each participant as a binary variable indicating if there was at least one documented referral to Palliative Care, Nutrition Services, and/or Social Work Services. | From the date of randomization until subject discontinued the intervention, assessed up to 34 months |
| Proportions of Missed Visits of All Scheduled Visits From 0% to 100%. | This proportion was calculated for each participant as the percentage of missed visits of all scheduled within Atrium Health, regardless of visit type. | From the date of randomization until subject discontinued the intervention, assessed up to 34 months |
| Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33 | Subject satisfaction was assessed by a modified European Organization for Research and Treatment of Cancer Patient Satisfaction with cancer care questionnaire #33 (EORTC PATSAT C33) 10-14 weeks after randomization. Subjects completed the questionnaire assessing thirty-four elements of their experience with regards to hospital environment, hospital personnel, and treatment. Each question was assessed on a Likert-type scale ranging Poor to Excellent (mapped numerically to 1-5), where the higher scores indicated a better experience. The average score was calculated for each subject as the sum of the non-missing standardized scores divided by the number of measures contributing to the sum. The average score could range from 1 (the minimum) to 5 (the maximum). | From the date of randomization up until 14 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Full Range | 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 | Number | participants |
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| Diagnosis | Count of Participants | Participants |
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| Oncology Nurse Navigation |
Standard of Care + Oncology Nurse Navigation Oncology Nurse Navigation: Providing the subject with the service of navigation (ONN) performed under LCI Patient Navigation Program (LPNP), led by a registered oncology nurse. |
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| Primary | Proportion of Participants Surviving at 6 Months | The proportion of participants surviving at 6 months was calculated for each treatment arm. Six-month overall survival was determined for each subject as a binary variable indicating whether or not the subject was alive at 6 months after study enrollment. Failure occurred if the subject died from any cause within 6 months of study enrollment. The proportions were compared between the arms. | Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date and (b) died within six months of enrollment or otherwise were on study for at least 6 months. | Posted | Count of Participants | Participants | From the date of randomization to death or 6 months |
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| Secondary | Proportion of Participants Surviving at 12 Months | The proportion of participants surviving at 12 months was calculated for each treatment arm. Six-month overall survival was determined for each subject as a binary variable indicating whether or not the subject was alive at 12 months after study enrollment. Failure occurred if the subject died from any cause within 12 months of study enrollment. The proportions were compared between the arms. | Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date and (b) died within six months of enrollment or otherwise were on study for at least 6 months. | Posted | Count of Participants | Participants | From the date of randomization up until 12 months |
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| Secondary | Hospital Length of Stay | Hospital length of stay was calculated for each subject as the total number of unplanned inpatient days while on intervention. | Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date and (b) died within six months of enrollment or otherwise were on study for at least 6 months. | Posted | Median | Inter-Quartile Range | Days | From the date of randomization until subject discontinued the intervention, assessed up to 34 months |
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| Secondary | Time From Hospice Referral to Death for Participants Referred to Hospice | Time from hospice referral to death was a time-to-event endpoint defined as the time from hospice referral to the date of death from any cause. Subjects who were alive or lost to follow-up at the time of the analysis were censored at the last known date they were alive. This endpoint was only calculated for subjects referred to hospice. | Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date, (b) died within six months of enrollment or otherwise were on study for at least 6 months, and (c) were referred to hospice (82/228 participants). | Posted | Median | 95% Confidence Interval | months | From the date of hospice referral to death or last follow-up, assessed over 7 months. |
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| Secondary | Total Number of 30-day Readmissions | The number of readmissions within 30 days of in-patient admission discharges was calculated for each participant. This outcome was derived for each subject with at least one in-patient admission. | Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date, (b) died within six months of enrollment or otherwise were on study for at least 6 months, and (c) had at least one in-patient admission (115/228 participants). | Posted | Median | Inter-Quartile Range | number of 30-day readmissions | From the date of randomization until subject discontinued the intervention, assessed up to 34 months |
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| Secondary | Proportion of Participants Referred to Supportive Care Services | Referral to Supportive Care Services was derived for each participant as a binary variable indicating if there was at least one documented referral to Palliative Care, Nutrition Services, and/or Social Work Services. | Enrolled participants who both (a) receive at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date and (b) die within six months of enrollment or otherwise are on study for at least 6 months. | Posted | Count of Participants | Participants | From the date of randomization until subject discontinued the intervention, assessed up to 34 months |
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| Secondary | Proportions of Missed Visits of All Scheduled Visits From 0% to 100%. | This proportion was calculated for each participant as the percentage of missed visits of all scheduled within Atrium Health, regardless of visit type. | Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date and (b) died within six months of enrollment or otherwise were on study for at least 6 months. | Posted | Median | Full Range | percentage of missed scheduled visits | From the date of randomization until subject discontinued the intervention, assessed up to 34 months |
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| Secondary | Average Score of Subject Satisfaction as Assessed by an Adaptation of the EORTC PATSAT C33 | Subject satisfaction was assessed by a modified European Organization for Research and Treatment of Cancer Patient Satisfaction with cancer care questionnaire #33 (EORTC PATSAT C33) 10-14 weeks after randomization. Subjects completed the questionnaire assessing thirty-four elements of their experience with regards to hospital environment, hospital personnel, and treatment. Each question was assessed on a Likert-type scale ranging Poor to Excellent (mapped numerically to 1-5), where the higher scores indicated a better experience. The average score was calculated for each subject as the sum of the non-missing standardized scores divided by the number of measures contributing to the sum. The average score could range from 1 (the minimum) to 5 (the maximum). | Enrolled participants who both (a) received at least one dose of standard of care systemic anti-cancer therapy on or after the enrollment date, (b) died within six months of enrollment or otherwise were on study for at least 6 months, and (c) completed the subject satisfaction survey 10-14 weeks after randomization (86/228 participants). | Posted | Mean | Standard Deviation | score on a scale (out of 5) | From the date of randomization up until 14 weeks |
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| 115 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Oncology Nurse Navigation | Standard of Care + Oncology Nurse Navigation Oncology Nurse Navigation: Providing the subject with the service of navigation (ONN) performed under LCI Patient Navigation Program (LPNP), led by a registered oncology nurse. | 77 | 113 | 0 | 0 | 0 | 0 |
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| D005767 |
| Gastrointestinal Diseases |
| Superiority |
The proportions of evaluable subjects surviving at 6 months were analyzed in a 2x2 contingency table using Fisher's Exact test. In the SOC arm, 52/87(60%) evaluable subjects were alive at 6 months and 35/87 (40%) were not. In the ONN + SOC arm, 58/95 (61%) evaluable subjects were alive at 6 months and 37/95 (39%) were not. The p-value estimated using Fisher's Exact test on this 2x2 contingency table was p=0.88. |