This clinical trial develops and tests a mobile health (mHealth) intervention to improve adherence to lifestyle recommendations in colorectal cancer (CRC) survivors and their family caregivers. The current challenge for cancer survivorship is identifying novel approaches to help adhere to the lifestyle recommendations that have been shown to improve symptom burden, health outcomes, and health-related quality of life (HRQoL). The development of a digital health intervention specifically for CRC survivors and family caregivers may improve adherence to the American Cancer Society Nutrition and Physical Activity Guideline for Cancer Survivors and improve family health.
Additional locations may be listed on ClinicalTrials.gov for NCT06746012.
Locations matching your search criteria
United States
Ohio
Columbus
Ohio State University Comprehensive Cancer CenterStatus: Active
Contact: Roberto Martin Benzo
Phone: 614-293-3675
PRIMARY OBJECTIVES:
I. Conduct semi-structured interviews with 12 CRC survivors, 12 family caregivers, and 12 subject matter experts (SMEs) to assess the needs, contexts, and perspectives to improve engagement application (app).
II. Develop iterations of a working prototype app by collecting user feedback via semi-structured interviews, think-aloud sessions, and surveys in 12 survivors and 12 caregivers.
III. Conduct a 10-week, single-arm pilot study to test the digital lifestyle intervention's acceptability, feasibility, and intended effects in 10 CRC survivors-caregiver dyads.
OUTLINE:
PHASE I (DESIGN): Survivor-caregiver dyads and SMEs complete semi-structured interview over 60-90 minutes and surveys over 15 minutes for intervention content, format, and feature design and development on study
PHASE II (USER-EXPERIENCE TESTING): Dyads complete semi-structured interview and participate in think-aloud sessions over 60-90 minutes and complete surveys over 15 minutes to test the Healthy Buckeyes app on study.
PHASE III (PILOT STUDY): Dyads use the Healthy Buckeyes app to set goals, self-monitor, elicit social support, reinforcement, time management, relapse prevention, and receive exercise videos and recipes tailored to CRC survivors on study. Dyads also watch three 3 minute videos on strategies for improving healthy lifestyle behaviors weekly, wear a Fitbit and use exercise bands, and receive health coaching over 10 weeks on study. Dyads will be prompted through the app to identify specific ways they will support each other (team activity and team huddle) in meeting their goals throughout the week for 10 weeks on study.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationOhio State University Comprehensive Cancer Center
Principal InvestigatorRoberto Martin Benzo