Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain
Condition: Neurofibromatosis Type 1; Plexiform Neurofibromas
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Neurofibroma, Plexiform; Chronic Pain
Study type: Interventional
Phase: Phase 3

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.
    

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 greater than or
           equal to 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 National Institutes of Health (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.
    

Intervention name(s): Acceptance and Commitment Therapy (ACT)
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Psychological Intervention; Coping; Mindfulness; Randomized