This phase II trial compares the effectiveness of Re-Invent, Integrate, Strengthen, Expand (RISE), a personalized self-management training program, to a standardized self-management training (SSMT) program in patients with colorectal cancer or gastrointestinal cancer. Colorectal cancer is the third most common cancer in the United States and is strongly linked to unhealthy lifestyle behaviors. Research has shown that healthy behaviors improve physical function, quality of life and patients have fewer recurrences and a longer survival. Low adherence to healthy lifestyle behaviors is a complex problem and there is currently little evidence-based guidance on how to promote healthy behavior changes. Behavioral interventions, such as RISE and SSMT, use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Personalized self-management training, such as RISE, may increase adherence to healthy behavior recommendations in patients with colorectal or gastrointestinal cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05984589.
Locations matching your search criteria
United States
California
Los Angeles
USC / Norris Comprehensive Cancer CenterStatus: Temporarily closed to accrual
Contact: Alix G. Sleight
Phone: 860-543-5586
Los Angeles General Medical CenterStatus: Temporarily closed to accrual
Contact: Charlean Ketchens
Phone: 323-865-3035
PRIMARY OBJECTIVE:
I. To test if there is a difference in World Cancer Research Fund/ American Institute for Cancer Research (WCRF/AICR) score between the intervention and control groups after the 6-week management program in patients with colorectal cancer (CRC) and other gastrointestinal (GI) cancers.
SECONDARY OBJECTIVES:
I. To evaluate whether there is a difference in general self-efficacy (as measured by Patient Reported Outcomes Measurement Systems [PROMIS]) between the intervention and control groups after the 6-week self-management program.
II. To evaluate whether there is a difference in health-related quality of life (as measured by PROMIS Global Health score) between the intervention and control groups after the 6-week self-management program.
III. 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.
EXPLORATORY OBJECTIVES:
I. To assess the evaluation and refinement of intervention delivery and study procedures.
II. To assess performance and satisfaction with everyday activities (as measured by Canadian Occupational Performance Measure [COPM]) by the end of the 6-week self-management programs.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients participate in RISE intervention which consists of an evaluation visit with an occupational therapist (OT) to establish short-term and long-term goals over 60 minutes on week 1, receive appropriate educational material and discuss progress on short-term goals with OT in weekly sessions over 30 minutes on weeks 2-5. Patients discuss long-term strategies, review progress and complete a semi-structured, patient-directed interview over 60 minutes on week 6.
ARM II: Patients participate in SSMT which includes 6 standardized sessions with OT containing pre-specified, standardized didactic content over 6 weeks.
After completion of study intervention, patients are followed up at 6 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUSC / Norris Comprehensive Cancer Center
Principal InvestigatorAlix G. Sleight
