Personalized vs Standardized Self-Management Training for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAlix G. Sleight, PhD, OTD, MPH, OTR/L

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Arash Asher, MD

Prior Safety Data

Trial Summary

What is the purpose of this trial?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 colorectal cancer (CRC) 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 CRC patients.

Eligibility Criteria

This trial is for adults over 18 who've had Stage I-III colorectal cancer in the last year, are willing to improve at least one lifestyle risk factor like diet or exercise, and can speak English. They should have moderate to low adherence to healthy behaviors but can't be planning major cancer treatments within 6 months or have stage IV cancers.

Inclusion Criteria

Scoring ≤3.5 on the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) Health Behavior Adherence Scale (Table 1) consistent with moderate to low adherence to healthy behavior recommendations (HBRs)

I am willing to work on improving my diet, exercise, body weight, or alcohol use.

Ability to speak, write, and read English sufficiently to allow for program participation

+3 more

Exclusion Criteria

My cancer has spread to other parts of my body.

Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation

I plan to undergo cancer treatment, excluding long-term hormonal or biologic therapy, within the next 6 months.

Participant Groups

The study compares two types of self-management training programs for colorectal cancer patients: a personalized program (PSMT) and a standardized one (SSMT). Each patient will undergo a 6-week course led by specialized occupational therapists to see if PSMT leads to better health behavior adherence.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: RISE-PSMTExperimental Treatment1 Intervention

Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program.

Group II: SSMTPlacebo Group1 Intervention

Standardized self-management training.