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NCT01633008 · ClinicalTrials.gov registry record · Early Phase 1
Acceptance and Commitment Therapy for Adolescents and Young Adults With Neurofibromatosis and Chronic Pain
A Early Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 28
- Enrollment target
NCT01633008: Completed Early Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01633008 is a Early Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01633008, a Early Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
Background: * Neurofibromatosis type 1 (NF1) is a genetic disorder that can cause frequent and significant pain. This pain can have a severe impact on a person s quality of life. * Acceptance and Commitment Therapy (ACT) is a new type of therapy that may help people manage pain. It teaches behavioral techniques that can be used to change how people react to pain. ACT may help people with NF1 cope better with the pain associated with the disorder. Researchers want to test ACT techniques to see if they can improve coping in people with NF1 pain. Objectives: \- To see if ACT can help treat chronic pain in adolescents and young adults who have NF1. Eligibility: \- Adolescents and young adults between 12 and 21 years of age who have chronic pain associated with NF1. Design: * Participants will be screened with a physical exam and medical history. They will also complete a set of questionnaires about their pain levels, quality of life, and medications that they are taking. * Participants will take part in a training workshop for ACT. It will consist of three 2-hour sessions over 2 consecutive days. The workshop will teach techniques for setting goals that reflect personal values, and changing the focus from pain avoidance to pain management. There will be practice exercises between each session. * At the end of the workshop, participants will receive a workbook with the exercises to continue to practice at home. Participants will be encouraged to spend at least 20 minutes, three times per week, on these practice exercises. * There will be a followup phone call to check on pain management after the workshop. * Three months after the first study visit, participants will complete the study questionnaires again from home. They will provide more information about how they are managing their pain. The questionnaires will be returned by mail in an envelope provided by the study team.
Interventions
- BEHAVIORAL ACT Workshop
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2012-06-15 |
| Est. Completion | 2017-01-10 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01633008
The ClinicalTrials.gov registry entry for NCT01633008 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ACT Workshop is the first listed.
NCT01633008 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01633008 about?
NCT01633008 is a clinical study titled "Acceptance and Commitment Therapy for Adolescents and Young Adults With Neurofibromatosis and Chronic Pain". Background: * Neurofibromatosis type 1 (NF1) is a genetic disorder that can cause frequent and significant pain. This pain can have a severe impact on a person s quality of life. * Acceptance and Commitment Therapy (ACT) is a new type of therapy that may help people manage pain. It teaches behavior...
What is the current status of trial NCT01633008?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 28 participants. The study started on 2012-06-15. Estimated completion is 2017-01-10.
What interventions are being tested in trial NCT01633008?
The interventions under investigation include: ACT Workshop (BEHAVIORAL).
Who is sponsoring clinical trial NCT01633008?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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