patients receive an individualized "prescription" for survivorship care prepared by a cancer survivor specialist to be implemented by the primary care doctor

patient attends a specialty survivor clinic at Yale for survivorship care

empowered primary care model

specialty survivor clinic

Nina S Kadan-Lottick, MD, MSPH

The main purpose of this study is to research the comparative effectiveness of two potential models of health care to deliver preventive services and chronic care management to the growing population of adult and pediatric survivors of childhood cancer. The central hypothesis is that survivorship care delivered by a subject's primary care doctor after the subject is empowered with individualized follow-up recommendations prepared by a cancer survivor specialist is similar to care provided in a specialty survival clinic.

Although 80% of children with cancer will be cured of their primary disease, at least 70% of survivors will develop chronic medical, neurocognitive, and/or emotional conditions as a complication of their therapy. Most of these conditions are amenable to prevention and early intervention. In response, the Institute of Medicine strongly advised that all cancer patients should receive survivorship care with the following key elements: 1) a summary of previous cancer therapy, 2) individualized life-long screening for potential adverse therapy-related effects, and 3) education regarding desirable health behaviors. However, less than 30% of survivors receive recommended care. There is a tremendous need for research that addresses how to best implement evidence-based recommendations for this population.

Two main health care delivery models have been advocated for survivorship care, but no comparison studies exist. The first model is a specialty survivor clinic, usually at a cancer treatment center. The second model, termed the empowered primary care model, involves patients receiving an individualized "prescription" for follow-up care prepared by a cancer survivor specialist to be implemented by the primary care doctor. Each model poses unique strengths and weaknesses. Specialty survivor clinics can be expensive and geographically inaccessible, can cause anxiety and stress to patients, and can accommodate limited numbers of patients. Primary care doctors may lack adequate expertise and time for these complex patients. Unless we know how these approaches compare with regard to quality of care and risks, advocates and policy makers will be stymied in their efforts to support the health needs of cancer survivors. This study seeks to compare subjects randomized to the empowered primary care model vs. a specialty survivor clinic.

Comparing Two Modes of Survivorship Care

Comparing Two Modes of Survivorship Care: A Randomized Trial

adverse effects of receiving survivorship care

American Cancer Society, Inc.

Yale University

Infections

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Neoplasms

Digestive System Diseases

Symptoms and General Pathology

COVID-19

Influenza, Human

Vaccine-Preventable Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Communicable Diseases

All Drugs and Chemicals

Vaccines

$50/service patient financial incentive for completion of: COVID-19 shot, flu shot, colorectal cancer screening

$50/service patient financial incentive for completion of: COVID-19 shot, flu shot

$50 incentive paid to participant for completion of colorectal cancer screening within 2 months of enrollment

Financial incentive for colorectal cancer screening

$50 incentive paid to participant for completion of flu shot within 2 months of enrollment

Financial incentive for flu shot

$50 incentive paid to participant for completion of COVID-19 shot within 2 months of enrollment

Financial incentive for COVID-19 shot

Marie A Krousel-Wood, MD, MSPH

The goal of this pilot clinical trial is to determine feasibility and explore whether financial incentives paid to primary care patients for completing colorectal cancer screening increase completion of colorectal cancer screening. The main questions it aims to answer are:

* Do patient financial incentives for completing colorectal cancer screening increase screening completion?
* Does a patient financial incentive for colorectal cancer screening offered alongside patient financial incentives for COVID-19 and flu shots increase completion of those shots?

Participants who are due for colorectal cancer screening will receive telephone outreach from primary care staff who will offer a stool-based colorectal cancer screening. Participants will be randomly assigned to either Group 1 or Group 2. Group 1 participants will be offered financial incentives for completing COVID-19 and flu shots within 2 months of enrollment. Group 2 participants will be offered financial incentives for completing a COVID-19 shot, a flu shot, and colorectal cancer screening within 2 months of enrollment.

Researchers will compare to see if completion of a COVID-19 shot, a flu shot, and colorectal cancer screening is different between the two groups.

Participants will be randomly assigned to a study arm for the duration of their two months in the study

Primary care outreach staff will recruit and randomize participants and deliver the intervention. Group assignment will be documented in a separate study database not accessible by the primary care provider. Outcomes will be assessed in electronic health records data, which will be queried by primary care staff who do not have access to group assignment.

Building Engagement Using Financial Incentives Trial - Colorectal Cancer Screening

No IPD will be shared with other researchers

Number of patients with reachable phone numbers

Number of patients who begin eligibility screener

Number of patients who consent and are randomized

Number of patients who complete outreach call

Completion of colonoscopy, sigmoidoscopy, CT colonography, or stool-based colorectal cancer screening test as documented in electronic health record within two months of study enrollment

Completion of COVID-19 shot as documented in electronic health record within two months of study enrollment

Completion of flu shot as documented in electronic health record within two months of study enrollment

Completion of colorectal cancer screening (colonoscopy, sigmoidoscopy, CT colonography, or stool-based colorectal cancer screening test), COVID-19 shot, \*OR\* flu shot as documented in electronic health record within two months of study enrollment

Completion of colorectal cancer screening (colonoscopy, sigmoidoscopy, CT colonography, or stool-based colorectal cancer screening test), COVID-19 shot, \*AND\* flu shot as documented in electronic health record within two months of study enrollment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparing Two Modes of Survivorship Care	NCT02816866	Childhood Cance...	empowered prima... specialty survi...	1 Year - 29 Years	Yale University
Building Engagement Using Financial Incentives Trial - Colorectal Cancer Screening	NCT06124131	Health Behavior Colorectal Canc... Influenza COVID-19 Vaccine Hesitan... Vaccine-Prevent... Healthcare Pati...	Financial incen... Financial incen... Financial incen...	45 Years - 75 Years	Tulane University

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