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

NCT01633008 | Completed Early Phase 1

• 2 other identifiers: 12015512-C-0155
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurofibromatosis

Keywords

Modified Brief Pain Inventory; Quality of Life; Pain-Related Coping; Pain-Related Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• Pain improvement

  3 months

Secondary Outcomes (4)

• Value of the ACT for future Ph2 trial.

  6 months

• Psychological well-being & stress changes in parents

  3 months

• Explore improvements of pain interference, abilities, coping, anxiety,depression, etc

  3 months

• Relationship between pain and treatment adherence

  3 months

Study Arms (1)

1

EXPERIMENTAL

Attend three 2-hour sessions held over two consecutive days

Behavioral: ACT Workshop

Interventions

ACT Workshop BEHAVIORAL

The ACT workshops will consist of a patient program and a corresponding parent program, each focusing on helping participants cope with the patient s pain more effectively using ACT techniques

1

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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):
• 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)
• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Babovic-Vuksanovic D, Widemann BC, Dombi E, Gillespie A, Wolters PL, Toledo-Tamula MA, O'Neill BP, Fox E, MacDonald T, Beck H, Packer RJ. Phase I trial of pirfenidone in children with neurofibromatosis 1 and plexiform neurofibromas. Pediatr Neurol. 2007 May;36(5):293-300. doi: 10.1016/j.pediatrneurol.2007.01.009.

  PMID: 17509460 BACKGROUND

• Bach P, Hayes SC. The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: a randomized controlled trial. J Consult Clin Psychol. 2002 Oct;70(5):1129-39. doi: 10.1037//0022-006x.70.5.1129.

  PMID: 12362963 BACKGROUND

• Blount RL, Cohen LL, Frank NC, Bachanas PJ, Smith AJ, Manimala MR, Pate JT. The Child-Adult Medical Procedure Interaction Scale-Revised: an assessment of validity. J Pediatr Psychol. 1997 Feb;22(1):73-88. doi: 10.1093/jpepsy/22.1.73.

  PMID: 9019049 BACKGROUND

MeSH Terms

Conditions

Neurofibromatoses; Depression

Condition Hierarchy (Ancestors)

Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavioral Symptoms; Behavior

Study Officials

• Staci M Peron, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 4, 2012
• Study Start: June 15, 2012
• Primary Completion: May 1, 2014
• Study Completion: January 10, 2017
• Last Updated: September 30, 2019

Record last verified: 2017-01-10

Locations

US (1)