RECRUITING

Designing a Dyad-Based MHealth Intervention to Improve Adherence to Lifestyle Recommendations in Colorectal Cancer Survivors and Their Family Caregivers

Conditions

Stage 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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-03

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06746012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066

OSUCCCClinicaltrials@osumc.edu

Macy Tetrick

CONTACT

Macy.tetrick@osumc.edu

Principal Investigator

Roberto M Benzo, PhD

PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

United States

Collaborators and Investigators

Sponsor: Ohio State University Comprehensive Cancer Center

Roberto M Benzo, PhD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-03

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-05-03

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Stage 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