NCT04763174Completed
An mHealth Symptom Management Intervention for Colorectal Cancer Patients (mCOPE)
An mHealth Symptom Management Intervention for Colorectal Cancer Patients
Source: ClinicalTrials.gov · Last updated 16 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 167 (actual)
- First submitted
- 17 Feb 2021
- Start date
- 15 Sept 2021
- Primary completion date
- 6 Dec 2024
- Lead sponsor
- Duke University
- Diseases
- Colorectal cancer
- NCT number
- NCT04763174
What you commit to
- Study type: Interventional
- Participants enrolled: 167
- From 15 Sept 2021 to the primary completion date, 6 Dec 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Participation in a coping skills training protocol in the past 6 months
- Inability to converse in English
Who the study is looking for
- 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
Age in the registry: 18 years to 50 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke Regional Hospital Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Duke Cancer Institute Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.