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

This study is currently recruiting participants.
Verified October 6, 2017 by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02471339
First Posted: June 15, 2015
Last Update Posted: October 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
  Purpose

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 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 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 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.

Condition Intervention Phase
Neurofibromatosis Type 1 Plexiform Neurofibromas Other: Acceptance and Commitment Therapy (ACT) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain: A Phase III Clinical Trial

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):

Primary Outcome Measures:
  • compare pain interference mean score changes from baseline to 8 weeks [ Time Frame: 8 weeks ]
  • examine baseline to post-treatment changes in disease-related quality of life, pain severity, depression, pain-related anxiety, and heart rate variability (HRV) [ Time Frame: 8 weeks ]
  • Compare groups in terms of pre-post changes in diseaserelated quality of life, pain severity, depression, pain-related anxiety, and HRV [ Time Frame: 8 weeks ]
  • Examine the pattern of change from baseline to 8 weeks to 32weeks post-intervention [ Time Frame: 32 weeks ]
  • Examine mediators between pre- and post-treatment paininterference [ Time Frame: 1.5 years ]
  • Assess and compare the psychometric properties of the two pain interference measures (PII and PROMIS) [ Time Frame: 1.5 years ]

Estimated Enrollment: 90
Study Start Date: June 1, 2015
Estimated Study Completion Date: June 30, 2018
Estimated Primary Completion Date: January 31, 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Acceptance and Commitment Therapy (ACT)
    Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain.
Detailed Description:

BACKGROUND:

  • Neurofibromatosis type 1 (NF1) is a genetic disorder that affects approximately 1 in 3,500 individuals.
  • A number of common clinical manifestations, including plexiform neurofibromas, can cause frequent and significant pain and impact quality of life.
  • Often, NF1-related pain is not well-controlled with medication and many of the medications cause significant side effects.
  • To our knowledge, only one prior study (by our group) has examined the effectiveness of a psychological intervention for chronic pain in adolescents and young adults (AYA) with NF1.
  • Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain.
  • The goal of ACT is not to eliminate the person s pain, but to optimize the person s functioning despite their pain

OBJECTIVES:

-To compare pain interference mean score changes from baseline to 8 weeks between the ACT intervention group and the waitlist (WL) group.

ELIGIBILITY:

  • Patients 16 - 59 years of age with a confirmed diagnosis of NF1 and >1 plexiform neurofibroma (PN).
  • The patient must obtain a mean score of 2.0 or higher or a score of 3 on three or more items on the Pain Interference Index, and report having pain that interferes with functioning for at least three months.
  • The patient must have regular access to a computer or tablet with internet access.

DESIGN:

  • This is a psychological intervention study to determine the potential benefit of ACT on pain interference, with patients randomized to the ACT intervention or a wait-list control group.
  • Patients will come to the NIH for a 2-day visit (Time 1). After baseline assessments (questionnaires and ECG) are completed, participants in the ACT group will take part in two 2-hour ACT training sessions. At home, this group will receive weekly emails through week 8, and will participate in further ACT training/educational sessions via video chat at weeks 2, 4, and 6.
  • All patients will return to the NIH at week 8 (Time 2) to complete follow-up questionnaires and ECG. At this time, the WL group will cross over and receive the ACT intervention (in-person sessions, weekly emails, and video chat sessions). All patients will complete questionnaires again from home six months following the completion of the intervention.
  • To detect a change of .68 standard deviation on the primary outcome measure between the two groups at .80 power, 41 patients per group are needed.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA FOR PARTICIPANT

    1. Patients must be between 16 and 59 years of age at the time of the baseline assessment. Because the research on the effectiveness of ACT with younger children is still emerging, children 15 and younger will be excluded from the present study.
    2. Diagnosis of NF1 through germline mutation OR clinical diagnosis; for the clinical diagnosis of NF1 all study subjects must have two or more diagnostic criteria for NF1 listed below (NIH Consensus Conference):

      • Six or more cafe-au-lait spots (greater than or equal to 0.5 cm in prepubertal subjects or greater than or equal to 1.5 cm in postpubertal subjects)
      • Greater than or equal to 2 neurofibromas or 1 plexiform neurofibroma
      • Freckling in the axilla or groin
      • Optic glioma
      • Two or more Lisch nodules
      • A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex)
      • A first-degree relative with NF1
    3. Participants must have documentation of a PN, based on either clinical exam or imaging.
    4. Patient must self-report having chronic pain for at least the past 3 months that has interfered with their daily functioning, as assessed by the Pain Interference Index (must get a mean score of 2.0 or higher, or score a 3 on three or more individual items).
    5. Patients must have regular access to a computer or tablet with internet access.
    6. Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
    7. No anticipated major changes in their pain treatment regimen (i.e., new class of pain medication starting or change in the class of pain medication) or enrollment on a new treatment study presumed to impact pain in the near future.
    8. Subjects must be able to read and comprehend the English language, since the highly trained ACT therapists are not fluent enough to conduct the trainings in Spanish or other languages.

EXCLUSION CRITERIA FOR PARTICIPANT

  1. In the opinion of the PI or an AI, the subject has significant cognitive or emotional difficulties that would prevent them from being able to understand and/or participate fully in the intervention or the measures.
  2. Subjects who are participating in any other treatment studies, either medical or behavioral, specifically for pain management.
  3. Subjects who began a medical intervention for treatment of their disease that has a possible impact on pain (including MEK trials) will not be eligible until after one year on the medical treatment; at that time, eligibility will be discussed with the PI of the medical study to assess the stability of the patient s pain and whether further pain-related changes due to the medical treatment are likely.
  4. Inability to travel to the NIH, for example, due to physical limitations, for the in-person evaluation(s).

No groups in regards to gender, race, or ethnicity are being excluded from participation in the trial.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471339


Contacts
Contact: Staci M Peron, Ph.D. (240) 760-6025 martins@mail.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office    888-624-1937      
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Staci M Peron, Ph.D. National Cancer Institute (NCI)
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02471339     History of Changes
Other Study ID Numbers: 150142
15-C-0142
First Submitted: June 12, 2015
First Posted: June 15, 2015
Last Update Posted: October 10, 2017
Last Verified: October 6, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Psychological Intervention
Coping
Mindfulness
Randomized

Additional relevant MeSH terms:
Neurofibromatoses
Neurofibroma
Neurofibromatosis 1
Neurofibroma, Plexiform
Chronic Pain
Nerve Sheath Neoplasms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Peripheral Nervous System Diseases
Neuromuscular Diseases