Personalized Health Self-Management Training for Colorectal Cancer Survivors

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT05984589
Status
Recruiting
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Conditions

  • Behavior, Health
  • Colorectal Cancer
  • Gastrointestinal Cancers
  • Health Behavior
  • Healthy Lifestyle

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RISE Personalized Self-Management Training (PSMT) — BEHAVIORAL
    Along with patient education and internalization of self-determination, the RISE intervention focuses on replacing unhealthy habits with health-promoting habits. Ongoing practice and guidance in generating and enacting SMART (specific, measurable, achievable, realistic, and time-bound) health goals is the centerpiece of the RISE intervention. Working one-on-one with the PI, participants will set goals and develop practical strategies to establish sustainable healthy behavior (HB) change. Motivational interviewing, cognitive behavioral therapy, and patient education will accompany intensive collaborative problem-solving and creation of accountability structures to create lasting change. The 6-week intervention includes 2 in-person visits and 4 videoconference sessions.
  • Standardized Self-Management Training (SSMT) — BEHAVIORAL
    Participants randomized to the control condition will receive 6 standardized sessions from one of the occupational therapy (OT) interveners, matched to the PSMT for setting. At these visits, participants will be presented with slides containing pre-specified, standardized didactic content about the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) healthy behavior recommendations (HBRs). We hypothesize that these visits will control for the effect of research participation and increased knowledge about HBRs, and that simply providing standardized didactic content as an intervention modality without any personalization will have negligible effects on participants' healthy behaviors (HBs), self-efficacy, or quality of life. Content will follow the WCRF/AICR HBRs. Weeks 1-2 will focus on physical activity; weeks 3-4 will focus on diet and alcohol, and weeks 5-6 will focus on weight management and generalized strategies for HB change.

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Mar 2026
Primary completion
Sep 1, 2027
Completion
Nov 30, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: RISE-PSMT
    Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program.
  • Placebo Comparator: SSMT
    Standardized self-management training.

Primary Outcome Measure

To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups. [ Time Frame: 12 weeks. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
University of Southern CaliforniaLos AngelesCalifornia90089
Johanna Carrera
[email protected]
323-442-0146
Alix G [email protected], PhD, OTD, MPH, OTR/L (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of Southern California· Los Angeles, CA

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