Actively Recruiting
A Prospective, Randomized, Controlled Study Comparing RISE Personalized Self-Management Training to Standardized Training in Gastrointestinal Cancer Patients
Led by University of Southern California · Updated on 2026-04-02
120
Participants Needed
2
Research Sites
65 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating personalized self-management training (PSMT) compared to standardized self-management training (SSMT) in patients with gastrointestinal (GI) cancers, including colorectal cancer. This study is a Phase 2, prospective, randomized, controlled trial involving 120 GI cancer patients. The goal is to find out if personalized training can better help patients stick to healthy behavior recommendations. Participants will be randomly assigned to one of two groups: the personalized RISE-PSMT program or the standardized SSMT program. Both programs last six weeks and involve licensed occupational therapists with doctoral training. The RISE-PSMT includes two in-person visits and four videoconference sessions focused on setting and achieving specific health goals using motivational techniques and cognitive behavioral therapy. The SSMT group receives six standardized sessions covering physical activity, diet, alcohol use, weight management, and general healthy behavior strategies. During the study, participants will complete assessments over 12 weeks to measure adherence to healthy behaviors using the WCRF/AICR score, general self-efficacy, and health-related quality of life via questionnaires. Researchers will track changes in specific healthy behavior components and overall quality of life. Participants are expected to be ambulatory and able to complete the program independently, with informed consent required prior to participation.
CONDITIONS
Brief Title
Personalized Health Self-Management Training for Colorectal Cancer Survivors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- History of Stage I-IV colorectal cancer or other gastrointestinal cancer within the past 10 years
- Ability to speak, write, and read English sufficiently to participate
- Willingness and interest to work on at least one lifestyle-related risk factor such as diet, physical activity, body composition, or alcohol use
- Scoring 3.5 or lower on the WCRF/AICR Health Behavior Adherence Scale or low-to-moderate adherence in any subcategory
- Ambulatory and independent in activities of daily living
- Written informed consent and ability to comply with study requirements
You will not qualify if you...
- Cognitive or mental impairments that would hinder participation in the program as determined by the study physician or Principal Investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 6 weeks
Participants receive either personalized self-management training (RISE-PSMT) or standardized self-management training (SSMT) focusing on healthy behavior change over 6 weeks.
2 in-person visits and 4 videoconference sessions
Duration - 6 weeks
Participants are monitored for outcomes related to self-efficacy, quality of life, and health behavior adherence after the self-management program.
1 to 2 visits depending on assessments
Trial Site Locations
Total: 2 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Active, Not Recruiting
2
University of Southern California
Los Angeles, California, United States, 90089
Actively Recruiting
Research Team
A
Alix G Sleight, PhD, OTD, MPH, OTR/L
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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