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NCT04763174 · ClinicalTrials.gov registry record · NA
An mHealth Symptom Management Intervention for Colorectal Cancer Patients (mCOPE)
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 167
- Enrollment target
NCT04763174: Completed NA study, sponsored by Duke University.
NCT04763174 is a NA study that has completed, run by Duke University. The registered enrollment target is 167 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04763174, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 167 participants
- Enrollment target
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.
Primary Outcome
Pain Severity will be assessed using the Brief Pain Inventory (BPI) by asking patients about worst, least, average and now pain on a 0 = no pain to 10 = pain as bad as you can imagine.
Interventions
- BEHAVIORAL mHealth Coping Skills Training for Symptom Management (mCOPE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 167 participants |
| Start Date | 2021-09-15 |
| Est. Completion | 2024-12-06 |
| Phase | NA |
What the finished NCT04763174 record still lists
NCT04763174 is an interventional study that assigns participants to a tested intervention. The registered 167 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which mHealth Coping Skills Training for Symptom Management (mCOPE) is the first listed.
NCT04763174 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04763174 about?
NCT04763174 is a clinical study titled "An mHealth Symptom Management Intervention for Colorectal Cancer Patients (mCOPE)". 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 doe...
What is the current status of trial NCT04763174?
This trial is currently completed. It is a NA study. The enrollment target is 167 participants. The study started on 2021-09-15. Estimated completion is 2024-12-06.
What interventions are being tested in trial NCT04763174?
The interventions under investigation include: mHealth Coping Skills Training for Symptom Management (mCOPE) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04763174?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04763174's enrollment target sits among peer trials
167 622nd of 2000 higher than 1,376 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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