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NCT03207360 · ClinicalTrials.gov registry record · NA
Pain Coping Skills and Meaning-Centered Intervention
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
NCT03207360 is a NA study that has completed, run by Duke University. The registered enrollment target is 31 participants.
The verdict
NCT03207360, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
Study Summary
The proposed study seeks to develop and test a novel psychosocial pain management intervention for patients with advanced cancer. It is hypothesized that the intervention will demonstrate feasibility, acceptability, and preliminary efficacy. The first aim is to develop a combined pain coping skills training and meaning-centered psychotherapy intervention. The second aim is to test the intervention's feasibility and acceptability as well as preliminary efficacy for improving primary outcomes (i.e., pain, pain interference, and meaning in life) and secondary outcomes. Two efficacious, theory-driven interventions will be integrated to address pain management by teaching pain coping skills with a novel emphasis on enhancing a sense of meaning in life. Participants will be patients with advanced cancer and moderate-to-severe pain. The study will be conducted in two phases. Phase I of the study will be intervention development. The intervention content will be guided by theory and mentoring from a team of leading experts in pain management and meaning-centered psychotherapy. Initial intervention content will be further informed by interviews with patients with advanced cancer. Content will then be refined through an iterative patient testing process. Phase II of the study will be a single-arm pilot trial testing the intervention. The intervention will be delivered in-person and consist of four, 45-to-60 minute therapy sessions delivered using videoconferencing technology. Study measures will be collected at baseline (0 weeks), immediately post-intervention (5 weeks), and 4-weeks post-intervention (9 weeks).
Interventions
- BEHAVIORAL Pain Coping Skills
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2017-11-17 |
| Est. Completion | 2020-02-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03207360
The ClinicalTrials.gov registry entry for NCT03207360 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 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 Pain Coping Skills is the first listed.
NCT03207360 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03207360 about?
NCT03207360 is a clinical study titled "Pain Coping Skills and Meaning-Centered Intervention". The proposed study seeks to develop and test a novel psychosocial pain management intervention for patients with advanced cancer. It is hypothesized that the intervention will demonstrate feasibility, acceptability, and preliminary efficacy. The first aim is to develop a combined pain coping skills ...
What is the current status of trial NCT03207360?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2017-11-17. Estimated completion is 2020-02-11.
What interventions are being tested in trial NCT03207360?
The interventions under investigation include: Pain Coping Skills (BEHAVIORAL).
Who is sponsoring clinical trial NCT03207360?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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