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
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• PATIENTS INCLUSION:

• Adults (18 years of age or older)

• Diagnosis of stage I-III colon or rectal cancer

• Undergone curative-intent complete surgical resection (patients who have received non-operative management for rectal cancer may be eligible)

• Completed treatment (i.e., neo-adjuvant, adjuvant cytotoxic chemotherapy, radiation, or surgical resection) at least six months prior

• Own a smartphone with internet access and can receive text messages

• Able to speak, read, and understand English

• Self-report ability to independently engage in physical activity determined by the Physical Activity Readiness questionnaire (PAR-Q), and if indicated obtain physician clearance

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 determined via medical chart review

• Presence of a family caregiver (i.e., informal or formal caregiver) willing support the patient and participate in the study

• Able to provide informed consent

• FAMILY CAREGIVER INCLUSION:

• Any adult that resides in the same household as the patient

• Willing to participate in all aspects of the intervention and in the assessments required for those in the wait-list control condition if applicable

• Meets the patient inclusion criteria number 1, 5, 6, and 10

• SMES INCLUSION:

• Medical, radiation, and surgical oncologists; advanced practice providers, registered nurses; dietitians; exercise physiologists; physical therapists, patient navigators and champions/advocates, and social workers with at least 12 months of experience working with CRC survivors

Locations
United States
Ohio
Ohio State University Comprehensive Cancer Center
RECRUITING
Columbus
Contact Information
Primary
The Ohio State Comprehensive Cancer Center
OSUCCCClinicaltrials@osumc.edu
800-293-5066
Backup
Macy Tetrick
Macy.tetrick@osumc.edu
Time Frame
Start Date: 2024-05-03
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 70
Treatments
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.
Sponsors
Leads: Ohio State University Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov