Clinical trial · Interventional
Personalized Health Self-Management Training for Colorectal Cancer Survivors
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Behavior, Health | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastrointestinal Cancers | Malignant Digestive System Neoplasm | ALIAS | 0.90 |
| Health Behavior | — | UNRESOLVED | — |
| Healthy Lifestyle | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RISE Personalized Self-Management Training (PSMT) | Behavioral | — | UNRESOLVED |
| Standardized Self-Management Training (SSMT) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- RISE-PSMT
- description
- Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program.
- interventionNames
- Behavioral: RISE Personalized Self-Management Training (PSMT)
- type
- PLACEBO_COMPARATOR
- label
- SSMT
- description
- Standardized self-management training.
- interventionNames
- Behavioral: Standardized Self-Management Training (SSMT)
Primary outcomes (1)
- measure
- To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years at the time of consent. * A Diagnosis 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 or Spanish 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 lower two tertiles in any one subcomponent, 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.
References
Publications (0)
Data not yet available