Personalized Health Self-Management Training for Colorectal Cancer Survivors

NCT ID: NCT05984589

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2028-11-30

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

RISE-PSMT

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

Group Type: EXPERIMENTAL

RISE Personalized Self-Management Training (PSMT)

Intervention Type: 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.

SSMT

Standardized self-management training.

Group Type: PLACEBO_COMPARATOR

Standardized Self-Management Training (SSMT)

Intervention Type: 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.

Interventions

RISE Personalized Self-Management Training (PSMT)

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.

Intervention Type: BEHAVIORAL

Standardized Self-Management Training (SSMT)

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alix G Sleight, PhD, OTD, MPH, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status: ACTIVE_NOT_RECRUITING

University of Southern California

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Alix G Sleight, PhD, OTD, MPH, OTR/L

Role: CONTACT

alix.sleight@chan.usc.edu

323-442-0146

Facility Contacts

Johanna Carrera

Role: primary

Johanna.CarreraCajabon@med.usc.edu

323-442-0146

Other Identifiers

1K01HD110719

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3C-24-9

Identifier Type: -

Identifier Source: org_study_id