Recruiting

MHealth Intervention

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT06746012

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Discussion

Educational Activity

Internet-Based Intervention

Internet-Based Intervention

Interview

Study Details

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

Study ID

NCT06746012

Start date

May 3, 2024

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Discussion

Participate in think-aloud sessions

Educational Activity

Receive health coaching

Internet-Based Intervention

Use Healthy Buckeyes app

Internet-Based Intervention

Watch videos

Interview

Complete semi-structured interview

Medical Device Usage and Evaluation

Wear Fitbiit and use exercise bands

Questionnaire Administration

Ancillary studies

Supportive Care

Receive caregiver support

Survey Administration

Complete surveys

Primary outcome measure

  • Perceived usability (Phase II) [ Time Frame: Up to 1 year ]
  • End user's perception of the quality of the mHealth application (Phase II) [ Time Frame: Up to 1 year ]
  • User acceptance of mHealth services (Phase II) [ Time Frame: Up to 1 year ]
  • Usability (Phase III) [ Time Frame: Up to 1 year ]
  • Acceptability of the program (Phase III) [ Time Frame: Up to 1 year ]
  • End user's perception of the quality of the mHealth application (Phase III) [ Time Frame: Up to 1 year ]
  • Recruitment rate (Phase III) [ Time Frame: Up to 1 year ]
  • Adherence rate (Phase III) [ Time Frame: Up to 1 year ]
  • Retention rate (Phase III) [ Time Frame: Up to 1 year ]
  • Acceptability of the measurement rate (Phase III) [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

The Ohio State Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Macy Tetrick

Macy.tetrick@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Roberto M. Benzo, PhD

614-293-3675Roberto.Benzo@osumc.edu

Principal Investigator:

Roberto M. Benzo, PhD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Apr 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-04-09.