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

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Brief Title

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

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

Brief 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 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.
    

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 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.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Feasibility

Secondary Outcome

 Quality of life

Condition

Neurofibromatosis Type 1

Intervention

Acceptance and Commitment Therapy (ACT)

Study Arms / Comparison Groups

 1/ACT
Description:  2 ACT Training Sessions followed by weekly emails and video chats

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

67

Start Date

July 7, 2015

Completion Date

December 23, 2020

Primary Completion Date

December 23, 2020

Eligibility 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.
      

Gender

All

Ages

16 Years - 59 Years

Accepts Healthy Volunteers

No

Contacts

Staci M Peron, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02471339

Organization ID

150142

Secondary IDs

15-C-0142

Responsible Party

Sponsor

Study Sponsor

National Cancer Institute (NCI)


Study Sponsor

Staci M Peron, Ph.D., Principal Investigator, National Cancer Institute (NCI)


Verification Date

January 27, 2021