Recruiting

PSMT vs. SSMT

Sponsor:

University of Southern California

Code:

NCT05984589

Conditions

Colorectal Cancer

Healthy Lifestyle

Behavior, Health

Health Behavior

Gastrointestinal Cancers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RISE Personalized Self-Management Training (PSMT)

Standardized Self-Management Training (SSMT)

Study Details

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.

Conditions

Colorectal Cancer

Healthy Lifestyle

Behavior, Health

Health Behavior

Gastrointestinal Cancers

Study ID

NCT05984589

Start date

Mar 1, 2024

Status verified date

Sep, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: RISE-PSMT

Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program.

placebo comparator: SSMT

Standardized self-management training.

Interventions

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. 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)

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 outcome measure

  • To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups. [ Time Frame: 12 weeks. ]

Central Contacts and Locations

Central contacts

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

323-442-0146alix.sleight@chan.usc.edu

Locations

University of Southern California

Recruiting

Los Angeles, California, United States, 90089

Contacts

Johanna Carrera

323-442-0146Johanna.CarreraCajabon@med.usc.edu

Principal Investigator:

Alix G Sleight@chan.usc.edu, PhD, OTD, MPH, OTR/L

More Information

Sponsor

University of Southern California

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • self-management training

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-09-08.