NCT05984589 Personalized Health Self-Management Training for Colorectal Cancer Survivors
| NCT ID | NCT05984589 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Southern California |
| Condition | Colorectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-03-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Alix G Sleight, PhD, OTD, MPH, OTR/L
PRINCIPAL INVESTIGATOR
University of Southern California
Frequently Asked Questions
Who can join the NCT05984589 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colorectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05984589 currently recruiting?
Yes, NCT05984589 is actively recruiting participants. Contact the research team at alix.sleight@chan.usc.edu for enrollment information.
Where is the NCT05984589 trial being conducted?
This trial is being conducted at Los Angeles, United States, Los Angeles, United States.
Who is sponsoring the NCT05984589 clinical trial?
NCT05984589 is sponsored by University of Southern California. The principal investigator is Alix G Sleight, PhD, OTD, MPH, OTR/L at University of Southern California. The trial plans to enroll 120 participants.
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