RecruitingNot ApplicableNCT05984589

Personalized Health Self-Management Training for Colorectal Cancer Survivors

A Prospective, Randomized, Controlled, Double-Arm Study of RISE (Re-Invent, Integrate, Strengthen, Expand) Personalized Self-Management Training (PSMT) Compared to Standardized Self-Management Training (SSMT) in Gastrointestinal Cancer (GI) Patients


Sponsor

University of Southern California

Enrollment

120 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 2 prospective, randomized, controlled, double-arm study to assess personalized self-management training (PSMT) intervention efficacy and patient experiences compared to standardized self-management training (SSMT). A total of 120 gastrointestinal (GI) cancer patients will be enrolled and randomized 1:1 to complete a 6-week self-management training program (either PSMT or SSMT) to be carried out by licensed occupational therapists with doctoral training. This study aims to examine whether PSMT is more effective in increasing adherence to healthy behavior recommendations compared to SSMT in GI cancer patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a personalized self-management training program to help colorectal cancer survivors make healthier lifestyle changes — including diet, physical activity, and alcohol reduction — after completing cancer treatment. **You may be eligible if:** - You are 18 or older and have a history of stage I–IV colorectal cancer within the past 5 years - You can speak, read, and write in English - You are willing to work on at least one lifestyle change (diet, physical activity, body composition, or alcohol use) - Your current healthy behavior score suggests room for improvement **You may NOT be eligible if:** - You have cognitive or mental health impairments that would prevent participation - You are planning to receive active cancer treatment (radiation, chemotherapy, or major surgery) within 6 months of starting the program (long-term hormonal or biological therapy is acceptable) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALRISE Personalized Self-Management Training (PSMT)

Along with patient education and internalization of self-determination, the RISE intervention focuses on replacing unhealthy habits with health-promoting habits. Ongoing practice and guidance in generating and enacting SMART (specific, measurable, achievable, realistic, and time-bound) health goals is the centerpiece of the RISE intervention. Working one-on-one with the PI, participants will set goals and develop practical strategies to establish sustainable healthy behavior (HB) change. Motivational interviewing, cognitive behavioral therapy, and patient education will accompany intensive collaborative problem-solving and creation of accountability structures to create lasting change. The 6-week intervention includes 2 in-person visits and 4 videoconference sessions.

BEHAVIORALStandardized Self-Management Training (SSMT)

Participants randomized to the control condition will receive 6 standardized sessions from one of the occupational therapy (OT) interveners, matched to the PSMT for setting. At these visits, participants will be presented with slides containing pre-specified, standardized didactic content about the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) healthy behavior recommendations (HBRs). We hypothesize that these visits will control for the effect of research participation and increased knowledge about HBRs, and that simply providing standardized didactic content as an intervention modality without any personalization will have negligible effects on participants' healthy behaviors (HBs), self-efficacy, or quality of life. Content will follow the WCRF/AICR HBRs. Weeks 1-2 will focus on physical activity; weeks 3-4 will focus on diet and alcohol, and weeks 5-6 will focus on weight management and generalized strategies for HB change.


Locations(2)

Cedars-Sinai Medical Center

Los Angeles, California, United States

University of Southern California

Los Angeles, California, United States

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NCT05984589


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