Personalized Health Self-Management Training for Colorectal Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RISE Personalized Self-Management Training (PSMT), Standardized Self-Management Training (SSMT).
- Who it may be relevant to
- Registry conditions: Colorectal Cancer, Healthy Lifestyle, Behavior, Health, Health Behavior. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Behavioral 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. Motivat - 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 particip
Primary outcome measures
- To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups. [Time frame: 12 weeks.]
Secondary outcome measures (3)
- 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.]
- 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.]
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Cedars-Sinai Medical Center — Los Angeles
- University of Southern California — Los Angeles
Identifiers
NCT: NCT05984589 · 3C-24-9 · 1K01HD110719