NCT05984589Recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 2 Aug 2023
- Start date
- 1 Mar 2024
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- University of Southern California
- Diseases
- Colorectal cancer
- NCT number
- NCT05984589
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Mar 2024 to the primary completion date, 1 Sept 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Southern California Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Cedars-Sinai Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.