Health Trials

About this trial

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

Qualifiers

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.

Disqualifiers

Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation.

Trial design

Treatments tested in this trial

  • RISE Personalized Self-Management Training (PSMT)
  • Standardized Self-Management Training (SSMT)

Treatment groups

120 Participants
are divided into 2 treatment groups

Locations

2
Cedars-Sinai Medical Center90048, Los AngelesCalifornia, United States
University of Southern California90089, Los AngelesCalifornia, United States

Sponsors and collaborators

University of Southern California

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov