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Recruiting NCT06746012

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

No phase Interventional Stage I Colon Cancer AJCC v8 Stage I Rectal Cancer AJCC v8 Stage II Colon Cancer AJCC v8 Stage II Rectal Cancer AJCC v8

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Discussion, Educational Activity, Internet-Based Intervention, Internet-Based Intervention.
Who it may be relevant to
Registry 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. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Detailed description

PRIMARY OBJECTIVES:

I. Conduct a 12-week, single-arm pilot study to test the digital lifestyle intervention's acceptability, feasibility, and intended effects in 10 CRC survivors-caregiver dyads.

OUTLINE:

PHASE III (PILOT STUDY): Dyads use the Healthy Buckeyes app to set goals, self-monitor, elicit social support, reinforcement, time management, relapse prevention, and receive exercise videos and recipes tailored to CRC survivors on study. Dyads also watch three 3 minute videos on strategies for improving healthy lifestyle behaviors weekly, wear a Fitbit and use exercise bands, and receive health coaching over 10 weeks on study. Dyads will be prompted through the app to identify specific ways they will support each other (team activity and team huddle) in meeting their goals throughout the week for 10 weeks on study.

Interventions

  • Procedure Discussion
    Participate in think-aloud sessions
  • Other Educational Activity
    Receive health coaching
  • Other Internet-Based Intervention
    Use Healthy Buckeyes app
  • Other Internet-Based Intervention
    Watch videos
  • Other Interview
    Complete semi-structured interview
  • Other Medical Device Usage and Evaluation
    Wear Fitbiit and use exercise bands
  • Other Questionnaire Administration
    Ancillary studies
  • Other Supportive Care
    Receive caregiver support
  • Other Survey Administration
    Complete surveys

Primary outcome measures

  • Perceived usability (Phase II) [Time frame: Up to 1 year]
  • End user's perception of the quality of the mHealth application (Phase II) [Time frame: Up to 1 year]
  • User acceptance of mHealth services (Phase II) [Time frame: Up to 1 year]
  • Usability (Phase III) [Time frame: Up to 1 year]
  • Acceptability of the program (Phase III) [Time frame: Up to 1 year]
  • End user's perception of the quality of the mHealth application (Phase III) [Time frame: Up to 1 year]
  • Recruitment rate (Phase III) [Time frame: Up to 1 year]
  • Adherence rate (Phase III) [Time frame: Up to 1 year]
  • Retention rate (Phase III) [Time frame: Up to 1 year]
  • Acceptability of the measurement rate (Phase III) [Time frame: Up to 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Ohio State University Comprehensive Cancer Center — Columbus

Identifiers

NCT: NCT06746012 · OSU-23222 · NCI-2024-01073

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗