Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Personalized self-management program to help colorectal cancer survivors adopt healthier habits

Official title: 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

Run by University of Southern California · NCT05984589 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment120 (estimated)
SponsorUniversity of Southern California
Academic / other
Locations2 sites (Los Angeles, California and 1 other locations)
StatusRecruiting
StartedMarch 1, 2024
Main results expectedSeptember 1, 2027
Study endsNovember 30, 2028
Registry record updatedSeptember 8, 2026
Trial IDNCT05984589 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age ≥18 years at the time of consent.
* A Diagnosis 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 or Spanish 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 lower two tertiles in any one subcomponent, 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 it's running

  • University of Southern California
    Los Angeles, California, United States
    Recruiting
  • Cedars-Sinai Medical Center
    Los Angeles, California, United States
    Active not 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.