Personalized self-management program to help colorectal cancer survivors adopt healthier habits
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
This study will test whether a 6-week personalized self-management program helps colorectal and other gastrointestinal cancer survivors stick to healthy behavior recommendations better than a standardized program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Trial ID | NCT05984589 on ClinicalTrials.gov |
What this trial studies
This randomized, double-arm Phase 2 study will enroll 120 gastrointestinal cancer survivors and randomize them 1:1 to a 6-week personalized self-management training (PSMT) or a standardized self-management training (SSMT). Both interventions are delivered by licensed occupational therapists with doctoral training. The primary outcome is adherence to healthy behavior recommendations, and researchers will also collect patient experience data. Eligible participants are adults within 10 years of a GI cancer diagnosis who report willingness to work on at least one lifestyle risk factor and show low-to-moderate adherence on the WCRF/AICR scale.
Who should consider this trial
Good fit: Adults aged 18 or older with a history of colorectal or other gastrointestinal cancer within the past 10 years who are ambulatory, English-speaking, willing to work on at least one lifestyle-related risk factor, and have low-to-moderate adherence to healthy behaviors per the WCRF/AICR scale.
Not a fit: Patients who are non–English speakers, non-ambulatory, have significant cognitive or severe mental impairment, or already demonstrate high adherence to healthy behavior recommendations are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the personalized program could help survivors adopt and maintain healthier diets, increase physical activity, and improve overall quality of life and long-term health.
How similar studies have performed: Prior behavioral and tailored lifestyle interventions in cancer survivors have shown improvements in diet and physical activity in some trials, but occupational-therapy–led personalized programs like this are less well studied.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years at the time of consent. * History of Stage I-IV colorectal cancer (CRC) or other gastrointestinal cancer within the past 10 years prior to enrollment. * Ability to speak, write, and read English sufficiently to allow for program participation. * Identified by self-report as having willingness and interest to work on at least one lifestyle-related risk factor. Lifestyle-related risk factors include diet, physical activity, body composition, alcohol use. * Scoring ≤3.5 on the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Health Behavior Adherence Scale or in the low-to-moderate range in any subcategory consistent with moderate to low adherence to healthy behavior recommendations (HBRs). * Ambulatory and independent in activities of daily living (ADL). * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation.
Where this trial is running
Los Angeles, California and 1 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Active_not_recruiting)
- University of Southern California — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Alix G Sleight, PhD, OTD, MPH, OTR/L — University of Southern California
- Study coordinator: Alix G Sleight, PhD, OTD, MPH, OTR/L
- Email: alix.sleight@chan.usc.edu
- Phone: 323-442-0146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.