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

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University Comprehensive Cancer Center
Study ID
NCT06746012
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 3, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Active Comparator: 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
  • Active Comparator: 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.
  • Experimental: 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.

Primary Outcome Measure

Perceived usability (Phase II) [ Time Frame: Up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Roberto M. Benzo, PhD
[email protected]
614-293-3675
Roberto M. Benzo, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Ohio State University Comprehensive Cancer Center· Columbus, OH

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