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NCT02471339 · ClinicalTrials.gov registry record · Phase 3
Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain
A Phase 3 study of Neurofibromatosis Type 1 and Plexiform Neurofibromas, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT02471339: Completed Phase 3 study of Neurofibromatosis Type 1 and Plexiform Neurofibromas, sponsored by National Cancer Institute (NCI).
NCT02471339 is a Phase 3 study of Neurofibromatosis Type 1 and Plexiform Neurofibromas that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 66 participants, below the 157-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02471339, a Phase 3 study of Neurofibromatosis Type 1 and Plexiform Neurofibromas, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- People with neurofibromatosis type I (NF1) and plexiform neurofibroma (PN) tumors often have chronic pain that his hard to control. People usually take medicines for the pain, but they may not work well and might cause side effects. A new strategy called Acceptance and Commitment Training (ACT) may help these people cope with chronic pain. ACT focuses on things like values and living in the moment. Objective: \- To see if Acceptance and Commitment Training improves pain coping in people with NF1 pain. Eligibility: \- People age 16-34 who have NF1, 1 or more PN tumors, and pain that interferes with their daily functioning. Design: * Participants will be screened with a physical exam, medical history, and questions about their pain. * Participants will fill out questionnaires about their pain and feelings. Their heart rate will be measured via electrocardiogram (ECG). * Participants will be divided into 2 groups randomly. One will wait 8 weeks. * The other will start training right away. * Participants will have 2 two-hour sessions with an ACT trainer. They will learn techniques for setting goals based on personal values and other ways to cope with pain. They will get a workbook and a compact disc (CD) to take home for practice. * Participants will do practice exercises at home between sessions. They will get weekly emails with a practice exercise. They will join video chat sessions via home computer with their trainer. * All participants will return to National Institutes of Health (NIH) after 8 weeks for questionnaires and an ECG. The wait group will then start training. They will return 8 weeks later for questionnaires and an ECG. * Six months later, they will complete questionnaires from home by computer.
Primary Outcome
Pain interference mean score changes were compared between the two groups from baseline to 8 weeks using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale.T-scores typically can range from 0 to 100, with "average" scores ranging from 41-59. No subscales are included in this measure. Higher scores indicate more pain interference (worse). A two-way repeated-measures analysis of covariance (ANCOVA) was used to examine changes between groups from baseline
Conditions Studied
Interventions
- BEHAVIORAL Acceptance and Commitment Therapy (ACT)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2015-07-07 |
| Est. Completion | 2020-12-23 |
| Phase | Phase 3 |
What the finished NCT02471339 record still lists
NCT02471339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 157-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (58% lower).
The record links to 2 conditions, with Neurofibromatosis Type 1 appearing as the primary indexed condition, and to 1 intervention - of which Acceptance and Commitment Therapy (ACT) is the first listed.
NCT02471339 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT02471339 about?
NCT02471339 is a clinical study titled "Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain". Background: \- People with neurofibromatosis type I (NF1) and plexiform neurofibroma (PN) tumors often have chronic pain that his hard to control. People usually take medicines for the pain, but they may not work well and might cause side effects. A new strategy called Acceptance and Commitment Tra...
What is the current status of trial NCT02471339?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 2015-07-07. Estimated completion is 2020-12-23.
What conditions does trial NCT02471339 study?
This clinical trial studies the following conditions: Neurofibromatosis Type 1, Plexiform Neurofibromas.
What interventions are being tested in trial NCT02471339?
The interventions under investigation include: Acceptance and Commitment Therapy (ACT) (BEHAVIORAL).
Who is sponsoring clinical trial NCT02471339?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02471339 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02471339's enrollment target sits among peer trials
66 11th of 17 higher than 7 of 17 other Neurofibromatosis Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurofibromatosis Type 1 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.
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