Mobile health intervention to help colorectal cancer survivors and their caregivers follow lifestyle recommendations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.