RecruitingNANCT06746012

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

Sponsor: Ohio State University Comprehensive Cancer Center

Trial Details

ConditionStage 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
InterventionDiscussion; Educational Activity; Internet-Based Intervention; Internet-Based Intervention; Interview; Medical Device Usage and Evaluation; Questionnaire Administration; Supportive Care; Survey Administration
PhaseNA
StatusRecruiting
Participants70
Est. Completion31 Dec 2026
Last Updated9 Apr 2026

Primary Outcome

Perceived usability (Phase II); End user's perception of the quality of the mHealth application (Phase II); User acceptance of mHealth services (Phase II); Usability (Phase III); Acceptability of the program (Phase III); End user's perception of the quality of the mHealth application (Phase III); Recruitment rate (Phase III); Adherence rate (Phase III); Retention rate (Phase III); Acceptability of the measurement rate (Phase III)

Eligibility Criteria

Inclusion 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

Trial Sites

Countries

United States
View Registry Entry

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