Personalized vs Standardized Self-Management Training for Colorectal Cancer

Phase 2

Recruiting

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

Research Sponsored by Arash Asher, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

This trial will compare two self-management programs to see which is more effective for colorectal cancer patients. It's led by occupational therapists with doctoral training.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves self-management training rather than medication, traditional side effects aren't expected. However, participants may experience stress or discomfort from lifestyle changes such as new diets or exercise routines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups.

Secondary study objectives

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.

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.

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 .