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

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.

Study Overview

• Status: Recruiting
• Conditions: Stage III Colon Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage II Rectal Cancer AJCC v8; Stage I Rectal Cancer AJCC v8; Stage I Colon Cancer AJCC v8; Stage II Colon Cancer AJCC v8
• Intervention / Treatment: Other: Questionnaire Administration; Other: Survey Administration; Procedure: Discussion; Other: Interview; Other: Educational Activity; Other: Internet-Based Intervention; Other: Internet-Based Intervention; Other: Medical Device Usage and Evaluation; Other: Supportive Care

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu
• Study Contact Backup: Name: Macy Tetrick; Email: Macy.tetrick@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Comprehensive Cancer Center
      • Contact: Roberto M. Benzo, PhD; Phone Number: 614-293-3675; Email: Roberto.Benzo@osumc.edu
      • Principal Investigator: Roberto M. Benzo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• PATIENTS EXCLUSION:
• People with potential contraindications to exercise based on the PAR-Q, for those we are unable to obtain physician clearance
• Planned major surgery during the study period
• Scheduled to receive any form of cancer therapy during study participation
• Concurrent, actively treated other cancer (except non-melanoma skin cancer, in situ cervical cancer or localized prostate cancer treated with surveillance only)
• Self-reported history of severe cardiovascular, respiratory, musculoskeletal disease, or joints problems that preclude moderate physical activity (PA)
• Self-reported history of psychiatric disorders that preclude participation in the study intervention or prevent the patient from giving informed consent
• Concurrent participation in another weight loss, PA, or dietary intervention clinical trial
• Currently pregnant or trying to become pregnant during the study period
• living outside the United States (US) during the study period
• Currently a prisoner
• FAMILY CAREGIVER EXCLUSION:
• The same as the patient exclusion criteria

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: Survey Administration; Complete surveys
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.	Other: Survey Administration; Complete surveys; Procedure: Discussion; Participate in think-aloud sessions; Other Names: Discuss; Other: Interview; Complete semi-structured interview
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.	Other: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Complete surveys; Other: Interview; Complete semi-structured interview; Other: Educational Activity; Receive health coaching; Other: Internet-Based Intervention; Use Healthy Buckeyes app; Other: Internet-Based Intervention; Watch videos; Other: Medical Device Usage and Evaluation; Wear Fitbiit and use exercise bands; Other: Supportive Care; Receive caregiver support; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived usability (Phase II)	Will be evaluated via the System Usability Scale (SUS), a ten-item questionnaire rated on a 5-point Likert scale, with a high level of reliability with a coefficient alpha of 0.91.	Up to 1 year
End user's perception of the quality of the mHealth application (Phase II)	Will be assessed using the User Mobile Application Rating Scale (uMARS), which includes 20 items rated on a 5-point scale and a total of six sections, including engagement, functionality, aesthetics, information quality, subjective quality, and perceived impact.	Up to 1 year
User acceptance of mHealth services (Phase II)	Will be assessed using the Technology Acceptance Model (TAM), which displays how users use and accept technology. The TAM includes 12 items divided into perceived usefulness and perceived ease of use.	Up to 1 year
Usability (Phase III)	Will be assessed using the SUS, a 10-item scale, with a score ranging from 0 to 100; where a score of > 68 is considered above average.	Up to 1 year
Acceptability of the program (Phase III)	Will be determined using the Net Promoter Score (NPS), a single-item 11-point scale asking, "How likely is it that you would recommend to a friend or colleague?" using the NPS survey (Reichheld, 2003). Will deem the program acceptable if the average score is >= 7.	Up to 1 year
End user's perception of the quality of the mHealth application (Phase III)	Will be assessed using the uMARS (Stoyanov, Hides, Kavanagh, & Wilson, 2016b), which includes 20 items rated on a 5-point scale and a total of six sections, including engagement, functionality, aesthetics, information quality, subjective quality, and perceived impact.	Up to 1 year
Recruitment rate (Phase III)	Will be defined as the percentage of screened and eligible participants who enroll, and determined 50% as an acceptable threshold.	Up to 1 year
Adherence rate (Phase III)	Will be defined as the number of participants who used the digital devices as indicated, and determined 70% as an acceptable threshold.	Up to 1 year
Retention rate (Phase III)	Will be defined as the percentage of enrolled participants who complete the program, and determined 70% as an acceptable threshold.	Up to 1 year
Acceptability of the measurement rate (Phase III)	Will be defined as the number of participants who complete both the baseline and post-assessment measures.	Up to 1 year

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Roberto M Benzo, PhD, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): December 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Rectal Neoplasms; Colonic Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Therapeutics; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Patient Care; Health Services; Health Care Facilities Workforce and Services; Interviews as Topic; Palliative Care
• Other Study ID Numbers: OSU-23222; NCI-2024-01073 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No