Personalized Health Self-Management Training for Colorectal Cancer Survivors
Recruiting · NCT05984589 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Southern California
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
2 locations listed across 1 US state.
- Cedars-Sinai Medical Center - Los Angeles, California, United States
- University of Southern California - Los Angeles, California, United States