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NCT Number: NCT05984589

Personalized Health Self-Management Training for Colorectal Cancer Survivors

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 gastrointestinal (GI) cancer 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 GI cancer patients.

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Key information

Conditions

Colorectal Cancer Behavior Behavior, Health Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Cancers Gastrointestinal Diseases Gastrointestinal Neoplasms Health Behavior Healthy Lifestyle Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years at the time of consent.
  • History of Stage I-IV colorectal cancer (CRC) or other gastrointestinal cancer within the past 10 years prior to enrollment.
  • Ability to speak, write, and read English sufficiently to allow for program participation.
  • 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.
  • 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).
  • Ambulatory and independent in activities of daily living (ADL).
  • Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion criteria

  • Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation.

Treatment and study plan

RISE Personalized Self-Management Training (PSMT)

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.

Standardized Self-Management Training (SSMT)

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. 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.

    Time frame: 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.

  2. 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 .

    Time frame: 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 scores 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 occurrences of fatigue, pain, or emotional problems.

  3. 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.

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

323-442-0146

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

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

Registry information

Official study title

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 Gastrointestinal Cancer (GI) Patients

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 9, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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