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Improving Lifestyle for Colorectal Cancer Survivors and Caregivers

This study is developing and testing a mobile app, called Healthy Buckeyes, to help colorectal cancer (CRC) survivors and their family caregivers stick to healthy lifestyle recommendations. These recommendations can improve symptoms, health, and quality of life after cancer treatment. The study aims to see how easy the app is to use, how good people think it is, and if they will accept using it. You may be able to join if you are an adult (18 or older) who has had stage I-III colon or rectal cancer and have finished your main treatment. This research hopes to find new ways to support CRC survivors and their families in maintaining a healthy lifestyle.

Study design
This is a single-arm pilot study involving 10 pairs of colorectal cancer survivors and their caregivers.
What's involved
Participants will use the Healthy Buckeyes app, watch weekly videos, wear a Fitbit, use exercise bands, and receive health coaching for 10 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 1 year to assess usability, quality, and acceptance of the mHealth application.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06746012

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

Recruiting
NAAges 18+InterventionalPrevention
Ohio State University Comprehensive Cancer Center
~70 participants
Updated 2026-04-09 on ClinicalTrials.gov
What's tested:DiscussionEducational ActivityInternet-Based InterventionInterviewMedical Device Usage and EvaluationQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Perceived usability (Phase II)
Measured over Up to 1 year
+9 more outcomes measured

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

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Colon CarcinomaRectal Carcinoma

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Roberto M Benzo, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center

Who to contact

The Ohio State Comprehensive Cancer Center
[email protected]
800-293-5066
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

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:

What this trial measures

  • Perceived usability (Phase II)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.

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

  • User acceptance of mHealth services (Phase II)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.

  • Usability (Phase III)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.

  • Acceptability of the program (Phase III)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.

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

  • Recruitment rate (Phase III)Up to 1 year

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

  • Adherence rate (Phase III)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.

  • Retention rate (Phase III)Up to 1 year

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

  • Acceptability of the measurement rate (Phase III)Up to 1 year

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