NCT06746012

Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers

Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers: Human-Centered Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. Conduct a 12-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 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.

Conditions

• Stage I Colon Cancer AJCC v8
• Stage I Rectal Cancer AJCC v8
• Stage II Colon Cancer AJCC v8
• Stage II Rectal Cancer AJCC v8
• Stage III Colon Cancer AJCC v8
• Stage III Rectal Cancer AJCC v8

Interventions

Type	Name	Description
PROCEDURE	Discussion	Participate in think-aloud sessions
OTHER	Educational Activity	Receive health coaching
OTHER	Internet-Based Intervention	Use Healthy Buckeyes app
OTHER	Internet-Based Intervention	Watch videos
OTHER	Interview	Complete semi-structured interview
OTHER	Medical Device Usage and Evaluation	Wear Fitbiit and use exercise bands
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Supportive Care	Receive caregiver support
OTHER	Survey Administration	Complete surveys

Timeline

• Start date: 2024-05-03
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-12-24
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States