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NCT Number: NCT06746012

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

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.

Recruiting

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Key information

Conditions

Stage I Colon Cancer AJCC v8 Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms 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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location status: Recruiting

Location contact

Roberto M. Benzo, PhD

CONTACT

[email protected]

614-293-3675

Roberto M. Benzo, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Discussion

Procedure

Participate in think-aloud sessions

Other names: Discuss

Educational Activity

Other

Receive health coaching

Internet-Based Intervention

Other

Use Healthy Buckeyes app

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

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Survey Administration

Other

Complete surveys

Primary outcomes

  1. Perceived usability (Phase II)

    Time frame: Up to 1 year

    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.

  2. End user's perception of the quality of the mHealth application (Phase II)

    Time frame: Up to 1 year

    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.

  3. User acceptance of mHealth services (Phase II)

    Time frame: Up to 1 year

    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.

  4. Usability (Phase III)

    Time frame: Up to 1 year

    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.

  5. Acceptability of the program (Phase III)

    Time frame: Up to 1 year

    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.

  6. End user's perception of the quality of the mHealth application (Phase III)

    Time frame: Up to 1 year

    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.

  7. Recruitment rate (Phase III)

    Time frame: Up to 1 year

    Will be defined as the percentage of screened and eligible participants who enroll, and determined 50% as an acceptable threshold.

  8. Adherence rate (Phase III)

    Time frame: Up to 1 year

    Will be defined as the number of participants who used the digital devices as indicated, and determined 70% as an acceptable threshold.

  9. Retention rate (Phase III)

    Time frame: Up to 1 year

    Will be defined as the percentage of enrolled participants who complete the program, and determined 70% as an acceptable threshold.

  10. Acceptability of the measurement rate (Phase III)

    Time frame: Up to 1 year

    Will be defined as the number of participants who complete both the baseline and post-assessment measures.

Study contacts

Contact information is provided by the study sponsor or research team.

Macy Tetrick

CONTACT

[email protected]

The Ohio State Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2024
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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