Designing a Dyad-Based MHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers
NCT ID: NCT06746012
Last Updated: 2024-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
70 participants
INTERVENTIONAL
2024-05-03
2026-12-31
Brief Summary
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Detailed Description
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I. Conduct semi-structured interviews with 12 CRC survivors, 12 family caregivers, and 12 subject matter experts (SMEs) to assess the needs, contexts, and perspectives to improve engagement application (app).
II. Develop iterations of a working prototype app by collecting user feedback via semi-structured interviews, think-aloud sessions, and surveys in 12 survivors and 12 caregivers.
III. 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 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
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.
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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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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
Survey Administration
Complete surveys
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.
Discussion
Participate in think-aloud sessions
Interview
Complete semi-structured interview
Survey Administration
Complete surveys
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.
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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:
18 Years
ALL
Yes
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Roberto Benzo
Principal Investigator
Principal Investigators
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Roberto M Benzo, PhD
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Central Contacts
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The Ohio State Comprehensive Cancer Center
Role: CONTACT
Phone: 800-293-5066
Email: [email protected]
Facility Contacts
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Roberto M. Benzo, PhD
Role: primary
Roberto M. Benzo, PhD
Role: backup
Related Links
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The Jamesline
Other Identifiers
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NCI-2024-01073
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-23222
Identifier Type: -
Identifier Source: org_study_id