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NCT04175639 · ClinicalTrials.gov registry record · NA
mHealth Behavioral Cancer Pain Intervention for Medically Underserved Patients
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 180
- Enrollment target
NCT04175639 is a NA study that has completed, run by Duke University. The registered enrollment target is 180 participants.
The verdict
NCT04175639, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 180 participants
- Enrollment target
Study Summary
The efficacy of a mobile health (mHealth) behavioral cancer pain intervention designed to decrease pain and disability for breast cancer patients in medically underserved areas has not been investigated. The long-term goal of this work is to use mHealth technologies to facilitate wide-spread implementation of an efficacious behavioral cancer pain intervention - a non-pharmacological approach to pain management. The proposed project's objective is to demonstrate the efficacy of an innovative mobile health Pain Coping Skills Training (mPCST-Community) designed to meet the needs of breast cancer patients with pain in medically underserved areas. mPCST-Community addresses intervention barriers for patients in medically underserved areas as it is delivered with video-conferencing in the patients' community based oncology clinic by a remote therapist, is extended to the patients' home environment using simple mHealth technology, and is low-literacy adapted. The central hypothesis is that mPCST-Community will result in decreased pain compared to a mHealth education attention control group (mHealth-Ed). The rationale of this proposal is that if mPCST-Community is shown to be efficacious it will rapidly increase intervention access for individuals who receive their oncology care in medically underserved areas and ultimately reduce pain-related suffering. Guided by strong preliminary data, a randomized controlled trial will be used to pursue three specific aims: 1) Test the extent to which the mPCST-Community intervention reduces pain, fatigue, disability, and distress, 2) Examine self-efficacy and pain catastrophizing as mediators through which the mPCST-Community leads to reductions in pain, fatigue, disability, and distress, and 3) To evaluate the cost-effectiveness of mPCST-Community. For Aim 1, based on the study team's extensive work demonstrating the efficacy of in-person pain coping skills training protocols and pilot work showing promise for mPCST-Community, it is ex
Interventions
- BEHAVIORAL Mobile Health Pain Coping Skills Training (mPCST)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2021-10-20 |
| Est. Completion | 2024-12-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04175639
The ClinicalTrials.gov registry entry for NCT04175639 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mobile Health Pain Coping Skills Training (mPCST) is the first listed.
NCT04175639 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04175639 about?
NCT04175639 is a clinical study titled "mHealth Behavioral Cancer Pain Intervention for Medically Underserved Patients". The efficacy of a mobile health (mHealth) behavioral cancer pain intervention designed to decrease pain and disability for breast cancer patients in medically underserved areas has not been investigated. The long-term goal of this work is to use mHealth technologies to facilitate wide-spread impleme...
What is the current status of trial NCT04175639?
This trial is currently completed. It is a NA study. The enrollment target is 180 participants. The study started on 2021-10-20. Estimated completion is 2024-12-20.
What interventions are being tested in trial NCT04175639?
The interventions under investigation include: Mobile Health Pain Coping Skills Training (mPCST) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04175639?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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