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

NCT06746012 | Recruiting DMC

• 2 other identifiers: OSU-23222NCI-2024-01073
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (3)

Phase I (design)

ACTIVE COMPARATOR

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

Phase II (user-experience testing)

ACTIVE COMPARATOR

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.

Procedure: Discussion; Other: Interview; Other: Survey Administration

Phase III (pilot study)

EXPERIMENTAL

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: Educational Activity; Other: Internet-Based Intervention; Other: Interview; Other: Medical Device Usage and Evaluation; Other: Questionnaire Administration; Other: Supportive Care; Other: Survey Administration

Interventions

Discussion PROCEDURE

Participate in think-aloud sessions

Also known as: Discuss

Phase II (user-experience testing)

Educational Activity OTHER

Receive health coaching

Phase III (pilot study)

Internet-Based Intervention OTHER

Use Healthy Buckeyes app

Phase III (pilot study)

Interview OTHER

Complete semi-structured interview

Phase II (user-experience testing); Phase III (pilot study)

Questionnaire Administration OTHER

Ancillary studies

Phase III (pilot study)

Supportive Care OTHER

Receive caregiver support

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Phase III (pilot study)

Survey Administration OTHER

Complete surveys

Phase I (design); Phase II (user-experience testing); Phase III (pilot study)

Medical Device Usage and Evaluation OTHER

Wear Fitbiit and use exercise bands

Phase III (pilot study)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

Interviews as Topic; Palliative Care

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Roberto M Benzo, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Macy Tetrick

CONTACT

Macy.tetrick@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: May 3, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)