Mobile health intervention to help colorectal cancer survivors and their caregivers follow lifestyle recommendations
Designing a Dyad-Based mHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers: Human-Centered Study
This study is testing a new mobile app to help colorectal cancer survivors and their caregivers stick to healthy lifestyle habits through goal-setting and coaching.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT06746012 on ClinicalTrials.gov |
What this trial studies
This clinical trial develops and tests a mobile health (mHealth) intervention aimed at improving adherence to lifestyle recommendations among colorectal cancer survivors and their family caregivers. The study involves conducting interviews to assess needs and perspectives, followed by the development of a prototype app based on user feedback. A 12-week pilot study will evaluate the app's acceptability and feasibility, where dyads will engage in goal-setting, self-monitoring, and receive tailored health coaching. The intervention includes exercise videos, recipes, and prompts to encourage healthy behaviors.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older who have been diagnosed with stage I-III colon or rectal cancer and have a family caregiver willing to participate.
Not a fit: Patients who are not able to engage in physical activity or do not have access to a smartphone with internet may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance the health outcomes and quality of life for colorectal cancer survivors and their caregivers.
How similar studies have performed: Other studies have shown success with mobile health interventions for cancer survivors, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Columbus, Ohio
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Roberto M Benzo, PhD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.