Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Duke University.
NCT04175639 is a NA study that has completed, run by Duke University. The registered enrollment target is 180 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Pain Severity will be assessed using the Brief Pain Inventory (BPI) by asking patients about pain on a scale of 0 = no pain to 10 = pain as bad as you can imagine.
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 |
What the finished NCT04175639 record still lists
NCT04175639 is an interventional study that assigns participants to a tested intervention. The registered 180 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 (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Mobile Health Pain Coping Skills Training (mPCST) is the first listed.
NCT04175639 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04175639's enrollment target sits among peer trials
180 586th of 2000 higher than 1,397 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01558804 · 180 participants
GRoup A StrePtococcus
- NCT02932176 · 180 participants
Machine Learning for Handheld Vascular Studies
- NCT03384563 · 180 participants · Phase 4
Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane
- NCT03423628 · 180 participants · Phase 1
A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI