RECRUITING

Personalized Health Self-Management Training for Colorectal Cancer Survivors - A Randomized, Controlled, Double-Arm Study

Description

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.

Study Overview

Study Details

Study overview

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.

A Prospective, Randomized, Controlled, Double-Arm Study of RISE (Re-Invent, Integrate, Strengthen, Expand) Personalized Self-Management Training (PSMT) Compared to Standardized Self-Management Training (SSMT) in Colorectal Cancer (CRC) Patients

Personalized Health Self-Management Training for Colorectal Cancer Survivors - A Randomized, Controlled, Double-Arm Study

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Los Angeles

University of Southern California, Los Angeles, California, United States, 90089

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥18 years at the time of consent.
  • 2. History of Stage I-IV colorectal cancer (CRC) within the past 5 years prior to enrollment.
  • 3. Ability to speak, write, and read English sufficiently to allow for program participation.
  • 4. 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.
  • 5. 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).
  • 6. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
  • 1. Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation.
  • 2. 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Southern California,

Alix G Sleight, PhD, OTD, MPH, OTR/L, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

2026-02-27