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

Completed · Not applicable

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT04763174

Run by

Duke University

People needed

167

Starts

2021-09-15

Expected to finish

2024-12-06

Last updated by the study team

2025-01-16

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of colorectal cancer within the past three years
• Stages I-IV
• Reported pain, fatigue and psychological distress - minimum two of three symptoms reported at 3 or greater on 0-10 scale
• Able to speak and read English

You may not qualify if…

• Cognitive impairment (e.g., dementia)
• Presence of a severe psychiatric condition (i.e., psychotic disorder or episode) or a psychiatric condition (e.g., suicidal intent)
• Participation in a coping skills training protocol in the past 6 months
• Inability to converse in English

Where it is running

• Duke Regional Hospital — Durham, North Carolina, United States
• Duke Cancer Institute — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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