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NCT02791646 · ClinicalTrials.gov registry record · NA
Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 327
- Enrollment target
NCT02791646: Completed NA study, sponsored by Duke University.
NCT02791646 is a NA study that has completed, run by Duke University. The registered enrollment target is 327 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02791646, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 327 participants
- Enrollment target
Study Summary
This trial is a sequential multiple assignment randomized trial (SMART), that will examine response to differing doses of a behavioral cancer pain intervention (Pain Coping Skills Training \[PCST\]) and subsequent response-based adjustments to doses. Cancer patients with pain will initially be randomized to receive either PCST-Full or PCST-Brief. Participants who do not report pain reduction to their initially assigned intervention will be re-randomized to receive either maintenance or an increased level of intervention. Participants who report pain reduction to their initially assigned intervention will be re-randomized to either a maintenance dose or no further treatment. Intervention responses will be compared across conditions using a standard two-sided, two-sample t-test. Techniques typically used for SMART studies will be used to compare intervention dosage sequences across PCTS that adjusts to initial dosage based on patient responses. The risk and safety issues in this trial are low and limited to those common to a psychosocial intervention (e.g., loss of confidentiality).
Primary Outcome
Pain intensity will be assessed by asking patients about their pain at its "worst", "least", "average", and "now". Patients will answer on a scale where 0 = "no pain" to 10 = "pain as bad as you can imagine". The worst, least, and average items will be asked in reference to the last 7 days. A composite averaged score of these four items will be used to represent pain intensity.
Interventions
- BEHAVIORAL Pain Coping Skills Training Full
- BEHAVIORAL Pain Coping Skills Brief
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 327 participants |
| Start Date | 2016-11-23 |
| Est. Completion | 2021-08-13 |
| Phase | NA |
What the finished NCT02791646 record still lists
NCT02791646 is an interventional study that assigns participants to a tested intervention. The registered 327 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 (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Pain Coping Skills Training Full is the first listed.
NCT02791646 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02791646 about?
NCT02791646 is a clinical study titled "Optimizing Delivery of a Behavioral Cancer Pain Intervention Using a SMART". This trial is a sequential multiple assignment randomized trial (SMART), that will examine response to differing doses of a behavioral cancer pain intervention (Pain Coping Skills Training \[PCST\]) and subsequent response-based adjustments to doses. Cancer patients with pain will initially be rando...
What is the current status of trial NCT02791646?
This trial is currently completed. It is a NA study. The enrollment target is 327 participants. The study started on 2016-11-23. Estimated completion is 2021-08-13.
What interventions are being tested in trial NCT02791646?
The interventions under investigation include: Pain Coping Skills Training Full (BEHAVIORAL), Pain Coping Skills Brief (BEHAVIORAL).
Who is sponsoring clinical trial NCT02791646?
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 NCT02791646's enrollment target sits among peer trials
327 309th of 2000 higher than 1,691 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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