Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06746012

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

Led by Ohio State University Comprehensive Cancer Center ยท Updated on 2026-04-09

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating a mobile health (mHealth) intervention designed to help colorectal cancer (CRC) survivors and their family caregivers follow lifestyle recommendations that may improve symptoms, health outcomes, and quality of life. The study focuses on developing a digital tool tailored to CRC survivors and caregivers to encourage adherence to nutrition and physical activity guidelines recommended by the American Cancer Society. The intervention includes using the Healthy Buckeyes app for goal setting, self-monitoring, social support, time management, and relapse prevention. Participants wear a Fitbit, use exercise bands, watch weekly short videos on healthy lifestyle strategies, and receive health coaching over 10 weeks. The study has multiple phases, including design, user-experience testing, and a 12-week pilot, where survivor-caregiver pairs engage in app-based activities and support each other. Participants will complete interviews, surveys, and think-aloud sessions to provide feedback on the app and intervention content. Researchers will assess usability, acceptability, recruitment, adherence, and retention rates over up to one year. The study involves monitoring participant engagement through the app and wearable devices to understand the program's effects and feasibility in improving lifestyle behaviors among CRC survivors and their family caregivers.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years of age or older
  • Diagnosed with stage I-III colon or rectal cancer
  • Completed curative-intent surgery and treatment at least six months prior
  • Own a smartphone with internet access and can receive text messages
  • Able to speak, read, and understand English
  • Able to engage in physical activity as determined by PAR-Q and physician clearance if needed
  • ECOG performance status of 0-2
  • Have a family caregiver willing to support and participate in the study
  • Family caregivers must live in the same household, be adults, and meet key patient criteria
  • Medical professionals with at least 12 months experience working with CRC survivors may participate as SMEs
Not Eligible

You will not qualify if you...

  • Contraindications to exercise without physician clearance
  • Planned major surgery during the study period
  • Scheduled to receive cancer therapy during the study
  • Active treatment for other cancers (except specific localized types)
  • History of severe cardiovascular, respiratory, musculoskeletal, or joint problems preventing moderate physical activity
  • History of psychiatric disorders preventing participation or informed consent
  • Participation in other weight loss, physical activity, or dietary intervention trials
  • Currently pregnant or trying to become pregnant during the study
  • Living outside the United States during the study
  • Currently a prisoner
  • Family caregivers excluded by the same criteria as patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote) for eligibility assessment

Phase I: Design Interviews

Duration - Single session

Survivor-caregiver dyads and subject matter experts complete semi-structured interviews and surveys to provide input for intervention content, format, and feature design.

1 visit lasting 75 to 105 minutes

Phase II: User-Experience Testing

Duration - Single session

Dyads complete interviews and think-aloud sessions and complete surveys to test the Healthy Buckeyes app usability and features.

1 visit lasting 75 to 105 minutes

Phase III: Pilot Study Intervention

Duration - 10 weeks

Dyads use the Healthy Buckeyes app for 10 weeks to set goals, self-monitor, and receive coaching and tailored exercise and nutrition content. They watch weekly videos, wear a Fitbit, use exercise bands, and engage in team activities to support their lifestyle changes.

Weekly app interactions and health coaching; wearable device usage throughout; periodic surveys and assessments

Trial Site Locations

Total: 1 location

1

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States, 43210

Actively Recruiting

Loading map...

Research Team

T

The Ohio State Comprehensive Cancer Center

M

Macy Tetrick

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

3

Similar Trials

Organ Preservation With Active Surveillance After Chemoradia...

Rectal Adenocarcinoma

Actively Recruiting

1 location

Establishing a ctDNA Biomarker to Improve Organ Preserving S...

Rectal Adenocarcinoma

Actively Recruiting

2 locations

Prospective Evaluation of Quality of Life and Utilities Foll...

Rectal Adenocarcinoma

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here