NCT06746012 Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers
| NCT ID | NCT06746012 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohio State University Comprehensive Cancer Center |
| Condition | Stage I Colon Cancer AJCC v8 |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-05-03 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2024-05-03 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Roberto M Benzo, PhD
PRINCIPAL INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06746012 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stage I Colon Cancer AJCC v8. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06746012 currently recruiting?
Yes, NCT06746012 is actively recruiting participants. Contact the research team at OSUCCCClinicaltrials@osumc.edu for enrollment information.
Where is the NCT06746012 trial being conducted?
This trial is being conducted at Columbus, United States.
Who is sponsoring the NCT06746012 clinical trial?
NCT06746012 is sponsored by Ohio State University Comprehensive Cancer Center. The principal investigator is Roberto M Benzo, PhD at Ohio State University Comprehensive Cancer Center. The trial plans to enroll 70 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.