Status:
RECRUITING
Personalized Health Self-Management Training for Colorectal Cancer Survivors
Lead Sponsor:
University of Southern California
Collaborating Sponsors:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Colorectal Cancer
Healthy Lifestyle
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 se...
Eligibility Criteria
Inclusion
- Age ≥18 years at the time of consent.
- History of Stage I-IV colorectal cancer (CRC) within the past 5 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).
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion
- Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation.
- Planning to have active anti-cancer treatment (including radiation, chemo, and/or major surgery) within 6 months after initial interventional or control session. Long-term hormonal/biologic therapy is acceptable.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05984589
Start Date
March 1 2024
End Date
November 30 2028
Last Update
July 17 2025
Active Locations (2)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of Southern California
Los Angeles, California, United States, 90089