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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares personalized training with standard training to help people follow healthy lifestyle advice. It is for adults diagnosed with colorectal cancer or another digestive system cancer within the past 10 years. Participants are assigned by chance to one of two 6-week programs led by occupational therapists.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older when you agree to join.
  • Have been diagnosed with stage I–IV colorectal cancer or another digestive system cancer within the past 10 years.
  • Be able to speak, read, and write English or Spanish well enough to take part.
  • Be willing and interested in improving at least one area: diet, physical activity, body fat and muscle levels, or alcohol use.
  • Score 3.5 or lower on the study’s healthy habits scale, or fall in the lower two-thirds for any one part of the scale.
  • Be able to walk and handle daily activities on your own.
  • Give written consent to join and be able to follow the study’s requirements.

Who can't join

  • Have thinking or mental health problems that the study leader or doctor believes would make it hard to take part.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

CA