Acceptance and Commitment Therapy for Adolescents and Young Adults With Neurofibromatosis and Chronic Pain

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Brief Title

Acceptance and Commitment Therapy for Adolescents and Young Adults With Neurofibromatosis and Chronic Pain

Official Title

Acceptance and Commitment Therapy for Adolescents and Adults With Neurofibromatosis Type 1 and Chronic Pain: A Pilot Study

Brief 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.
    

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,
           scoliosis, and chronic headaches, 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, no studies have examined the effectiveness of behavioral interventions
           for chronic pain in individuals 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 or distress.

             -  In helping individuals with pain, the goal of ACT is not to eliminate the person s
                pain, but to optimize the person s quality of life despite their pain.

      Objectives:

        -  To evaluate whether the Acceptance and Commitment Therapy (ACT) group demonstrates
           improvement on the Modified Brief Pain Inventory scale from baseline to 3 months in
           adolescents and young adults with NF1 and chronic pain.

        -  To examine changes in patient s functional ability, quality of life, pain-related
           coping, pain-related anxiety, pain severity, and depression from baseline to 3 months

        -  To examine the effects of ACT on parents psychological well-being, overall stress, and
           ability to cope with their child s pain

        -  To explore the relationship between changes in patients pain interference, functional
           ability, pain-related coping, pain-related anxiety, pain severity, depression and
           treatment adherence with demographic variables, parent stress, and parent coping

        -  To collect preliminary data on the value of ACT to guide the potential development of a
           future phase II trial

      Eligibility:

      Patients ages 12 to 21 with a confirmed diagnosis of NF1.-Parents of participating
      patients.-The patient must indicate a score of 3 or higher on a pain item (1 5 scale) from a
      quality of life measure assessing the extent to which pain has interfered with the patient s
      daily functioning over the past month.

      Design:

        -  This is a behavioral study to determine the feasibility and potential benefit of an ACT
           intervention on pain interference from baseline to 3 months post-intervention.

        -  A sample size of 12 patients is needed to provide 90% power for detecting a change of
           .77 standard deviations on the total pain interference score of the M-BPI using a
           1-sided .1 level test.

        -  ACT workshops will be scheduled multiple times over approximately five months and will
           be comprised of three 2-hour sessions held over two consecutive days

        -  Measures assessing pain interference, pain coping, pain-related anxiety, quality of
           life, functional disability, depression, and pain severity will be administered to
           patients prior to the ACT intervention and 3 months later.

        -  At the same time points, a parent or legal guardian of each patient will complete
           measures assessing their child s quality of life, functional disability, depression, and
           pain severity, as well as the parent s own psychological functioning and ability to cope
           with their child s pain
    

Study Phase

Early Phase 1

Study Type

Interventional


Primary Outcome

Pain improvement

Secondary Outcome

 Value of the ACT for future Ph2 trial.

Condition

Neurofibromatosis

Intervention

ACT Workshop

Study Arms / Comparison Groups

 1
Description:  Attend three 2-hour sessions held over two consecutive days

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

28

Start Date

June 15, 2012

Completion Date

January 10, 2017

Primary Completion Date

May 1, 2014

Eligibility Criteria

        -  INCLUSION CRITERIA FOR PARTICIPANT:

        Subjects must be between 12 and 21 years of age at the time of the intervention. Because
        the research on the effectiveness of ACT with children younger than 12 is still emerging,
        children 11 and younger will be excluded from the present study.

        For the clinical diagnosis of NF1 all study subjects must have two or more diagnostic
        criteria for NF1 listed below (NIH Consensus Conference):

          1. 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 postpuberta subjects)

          2. Greater than or equal to 2 neurofibromas or 1 plexiform neurofibroma

          3. Freckling in the axilla or groin

          4. Optic glioma

          5. Two or more Lisch nodules

          6. A distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of
             long bone cortex)

          7. A first-degree relative with NF1

             Response of 3 or higher on a pain item (1 5 scale) from a self-report quality of life
             measure (Impact of Pediatric Illness Scale) assessing the extent to which pain has
             interfered with the patient s daily functioning over the past month.

             Ability of subject or Legally Authorized Representative (LAR) to understand and the
             willingness to sign a written informed consent document.

             Subjects may be participating in other medical interventions for the treatment of
             their disease, or standard care techniques for pain management.

             No anticipated major changes in their pain regimen or enrollment on a new treatment
             study in the near future.

             Subjects must be able to read and comprehend the English language.

             EXCLUSION CRITERIA FOR PARTICIPANT:

             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.

             Subjects who are participating in any other treatment studies, either medical or
             behavioral, for pain management.

             Subjects who are scheduled to begin a new drug protocol for the treatment of their NF1
             during the time of their enrollment on the current study.

             Inability to travel to the NIH, for example, due to physical limitations, for the
             scheduled workshop and evaluations.

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

             INCLUSION CRITERIA FOR PARENTS:

             Parents must have a child with NF1 who is participating in this protocol as a patient.

             Ability to read and comprehend the English language.

             Ability to understand and the willingness to sign a written informed consent document.

             If a minor patient meets all eligibility criteria but his or her parent does not
             (i.e., in the case where a parent does not speak English), the patient will not be
             allowed to participate.
      

Gender

All

Ages

12 Years - 99 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Staci M Peron, Ph.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01633008

Organization ID

120155

Secondary IDs

12-C-0155

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 10, 2017