Personalized Self-Management Training Compared to Standardized Self-Management Training in Colorectal Cancer Patients.

Phase 2

Active, not recruiting

• Conditions: Colorectal Cancer; Healthy Lifestyle; Behavior, Health; Health Behavior
• Interventions: Behavioral: Standardized Self-Managament Training (SSMT); Behavioral: RISE Personalized Self-Managament Training (PSMT)

• Registration Number: NCT05984589
• Lead Sponsor: Arash Asher, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-02
• Study First Posted: 2023-08-09
• Study Start: 2024-03-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-02-27
• Study Completion: 2026-02-27

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age ≥18 years at the time of consent.
2. History of Stage I-III colorectal cancer (CRC) within the past 12 months 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 (Table 1) 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.
3. Known metastatic disease (Stage IV cancers).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSMT	Standardized Self-Managament Training (SSMT)	Standardized self-management training.
RISE-PSMT	RISE Personalized Self-Managament Training (PSMT)	Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program.

Primary Outcome Measures

Name	Time	Method
To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups.	12 weeks.	Outcome measures contributing to each component of WCRF/AICR Healthy Behavior Adherence scale will be collected from baseline and end-of-study visits (Session 6 and Follow-up). The WCRF/AICR scale comprises of 7 categories with each category given a score for non-/low adherence, moderate/some adherence, or full adherence to each HBR. Total value ranges from 0 to 7 points, with a higher score indicating better adherence. HBR items include body composition, physical activity, diet, and alcohol use.

Secondary Outcome Measures

Name	Time	Method
To evaluate the difference in health-related quality of life between the two groups after completion of the self-management program, we will use the PROMIS Scale v1.2 - Global Health questionnaire .	12 weeks.	Responses will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up Visit (6 weeks post Session 6).The questionnaire includes the following components to assess subject's rating on their global physical and mental health: 6 questions are each answered on a scale of 1-5 where higher scoores indicate excellent health, 1 question is answered on a scale of 1-5 where higher scores indicate being able to completely carry out everyday physical activities, and the last 3 questions are answered on a scale of 1-5 where higher scores indicate less frequency or no occurences of fatigue, pain, or emotional problems.
The difference in general self-efficacy between the two groups after the 6-week self-management program will be measured by Patient-Reported Outcomes Measurement Systems (PROMIS) Item Bank v1.0 - General Self-Efficacy Short Form 4a.	12 weeks.	Responses to this questionnaire will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up 6 Weeks Post-Session 6. The questionnaire asks the subject to rate their confidence levels in managing various situations, problems, and events. There are a total of 4 questions, and each question is answered on a scale of 1-4 where higher scores indicate the highest level of confidence. Total value ranges from 4 to 20, with a higher score indicating higher self-efficacy or highest level of confidence.
To assess percent change across the various component scores on the WCRF/AICR (e.g. grams of fiber) to better understand what might be driving any changes in the overall WCRF/AICR composite score.	12 weeks	To assess percent change across the various component scores on the WCRF/AICR, the WCRF/AICR will be collected at Screening, Baseline (Session 1) unless screening visit was \<30 days ago, End of Study Week 6 (Session 6), and Follow-up Visit (6 weeks Post Session 6).

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States