Personalized Health Self-Management Training for Colorectal Cancer Survivors

University of Southern California

Status: Enrolling

Conditions: Healthy Lifestyle; Health Behavior; Behavior, Health; Colorectal Cancer

Treatments: Behavioral: Standardized Self-Management Training (SSMT); Behavioral: RISE Personalized Self-Management Training (PSMT)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05984589

3C-24-9

1K01HD110719 (U.S. NIH Grant/Contract)

Details and patient eligibility

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 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups, including a placebo group

RISE-PSMT

Experimental group

Description:

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

Treatment:

Behavioral: RISE Personalized Self-Management Training (PSMT)

SSMT

Placebo Comparator group

Description:

Standardized self-management training.

Treatment:

Behavioral: Standardized Self-Management Training (SSMT)