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COMPLETED Phase 3

Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain

NCT02471339 · View on ClinicalTrials.gov ↗

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.

Interventions

  • BEHAVIORAL Acceptance and Commitment Therapy (ACT)

Study Locations (1)

Maryland

  • National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2015-07-07
Est. Completion 2020-12-23
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02471339

The ClinicalTrials.gov registry entry for NCT02471339 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 66 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 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02471339 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02471339?

The interventions under investigation include: Acceptance and Commitment Therapy (ACT) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02471339?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial