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An mHealth Symptom Management Intervention for Colorectal Cancer Patients (mCOPE)

NCT04763174 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2025-01-16

No results posted yet for this study

Summary

The investigators have developed an innovative mobile health (mHealth) coping skills training protocol, mCOPE, that is adapted to meet the multiple symptom needs and stage-of-life challenges faced by young and middle-aged adults with cancer, and delivered in a convenient and flexible format that does not incur further demands. Young and middle-aged colorectal cancer patients who report pain, fatigue, and psychological distress will be invited to participate in the study. Participants will be randomly assigned to one of two conditions: mCOPE or standard care. mCOPE will teach patients coping skills to manage their cancer-related symptoms (pain, fatigue and distress) in the context of unique age-related challenges; session content will be tailored based on participants' report. mCOPE sessions will be delivered via videoconferencing to the patient in his/her own environment and scheduled at times that are convenient to the patient. mHealth technology, including a mobile app, will be used to capture daily symptom and coping skills use data, allowing the study team to provide personalized real-time feedback to patients. Investigators want to understand the impact of the mCOPE intervention delivered to young and middle-aged colorectal cancer patients with pain, fatigue, and distress. mCOPE is expected to lead to reduced symptom severity and improved quality of life. Study aims include: testing the efficacy of mCOPE for improving symptoms and quality of life and examining improved self-efficacy for symptom management as a mediator of symptom severity.

Conditions

Interventions

BEHAVIORAL

mHealth Coping Skills Training for Symptom Management (mCOPE)

mCOPE participants will complete 5 videoconferencing sessions (within 5-9 weeks) with a psychologist, each lasting 45-60 minutes, from a location convenient to the patient (e.g., home, work). Sessions will include cognitive behavioral coping skills designed to target pain, fatigue and psychological distress symptoms unique to colorectal cancer patients. mCOPE will include a mobile app for: 1) coping skills content (e.g., audio, video), 2) daily symptoms assessment and coping skills use tracking transmitting in real-time to study staff, and 4) push notifications for reminders, encouragement, and personalized feedback.

Sponsors & Collaborators

Principal Investigators

  • Sarah A Kelleher, PhD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-15
Primary Completion
2024-12-06
Completion
2024-12-06

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04763174 on ClinicalTrials.gov