RECRUITING

Personalized Health Self-Management Training for Colorectal Cancer Survivors - A Randomized, Controlled, Double-Arm Study

Conditions

Colorectal Cancer Healthy Lifestyle Behavior, Health Health Behavior self-management training

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 colorectal cancer (CRC) 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 CRC patients.

Official Title

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 Colorectal Cancer (CRC) Patients

Quick Facts

Study Start:2024-03-01

Study Completion:2026-02-27

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05984589

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥18 years at the time of consent. 2. History of Stage I-IV colorectal cancer (CRC) within the past 5 years prior to enrollment. 3. Ability to speak, write, and read English sufficiently to allow for program participation. 4. 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. 5. 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). 6. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.	1. Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation. 2. Planning to have active anti-cancer treatment (including radiation, chemo, and/or major surgery) within 6 months after initial interventional or control session. Long-term hormonal/biologic therapy is acceptable.

Inclusion Criteria

Exclusion Criteria

1. Age ≥18 years at the time of consent.
2. History of Stage I-IV colorectal cancer (CRC) within the past 5 years prior to enrollment.
3. Ability to speak, write, and read English sufficiently to allow for program participation.
4. 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.
5. 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).
6. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

1. Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation.
2. Planning to have active anti-cancer treatment (including radiation, chemo, and/or major surgery) within 6 months after initial interventional or control session. Long-term hormonal/biologic therapy is acceptable.

Contacts and Locations

Study Contact

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

CONTACT

323-442-0146

alix.sleight@chan.usc.edu

Principal Investigator

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

PRINCIPAL_INVESTIGATOR

University of Southern California

Study Locations (Sites)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

University of Southern California

Los Angeles, California, 90089

United States

Collaborators and Investigators

Sponsor: University of Southern California

Alix G Sleight, PhD, OTD, MPH, OTR/L, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01

Study Completion Date2026-02-27

Study Record Updates

Study Start Date2024-03-01

Study Completion Date2026-02-27

Terms related to this study

Keywords Provided by Researchers

self-management training

Additional Relevant MeSH Terms

Colorectal Cancer
Healthy Lifestyle
Behavior, Health
Health Behavior