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NCT02783755 · ClinicalTrials.gov registry record · NA
A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT02783755 is a NA study that has completed, run by Duke University. The registered enrollment target is 20 participants.
The verdict
NCT02783755, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is two-fold. First, the investigator will develop a low-literacy Mobile Pain Coping Skills Training (mPCST) protocol for cancer patients with pain (i.e., therapist manual, patient manual including handouts, and the smartphone materials) as well as a beta version of the basic smartphone components with the assistance of experts in the field. Next, an iterative development design using focus groups with women who have breast cancer and pain accrued from medically underserved areas will be used to refine the developed mPCST protocol and basic smart phone components. The protocol-designed to reduce cancer pain and disability in patients with low literacy in medically underserved areas-will be delivered via tele-video conferencing sessions in the community clinic. The smartphone tools (e.g., simple text messages, images, and preloaded intervention content) will allow the intervention to extend into the patients' homes. The second study purpose is to pilot test the feasibility, acceptability, and efficacy of the developed protocol. The investigator will also obtain an estimate of the effect size of the developed protocol to decrease pain. Focus group data will be managed and evaluated in a systematic format using a grounded theory approach. Data analyses for the pilot testing period of the study will be assessed by examining accrual, attrition, and adherence to the intervention. Simple t-tests will be used to examine pre- to post-intervention differences in pain and the other outcomes of interest. There are minimal risk or safety issues related to this study.
Interventions
- BEHAVIORAL Device: smartphone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-05 |
| Est. Completion | 2017-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02783755
The ClinicalTrials.gov registry entry for NCT02783755 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 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 Device: smartphone is the first listed.
NCT02783755 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02783755 about?
NCT02783755 is a clinical study titled "A mHealth Behavioral Cancer Pain Protocol for Medically Underserved Communities". The purpose of this study is two-fold. First, the investigator will develop a low-literacy Mobile Pain Coping Skills Training (mPCST) protocol for cancer patients with pain (i.e., therapist manual, patient manual including handouts, and the smartphone materials) as well as a beta version of the basi...
What is the current status of trial NCT02783755?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2016-05. Estimated completion is 2017-06-30.
What interventions are being tested in trial NCT02783755?
The interventions under investigation include: Device: smartphone (BEHAVIORAL).
Who is sponsoring clinical trial NCT02783755?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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