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

NCT02471339 | Completed Phase 3 Results

• 2 other identifiers: 15014215-C-0142
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neurofibromatosis Type 1; Plexiform Neurofibromas

Keywords

Psychological Intervention; Coping; Mindfulness; Randomized

Outcome Measures

Primary Outcomes (1)

• Mean Pain Interference Mean Score Change From Baseline to 8 Weeks Between the Acceptance and Commitment Therapy Intervention Group and the Waitlist Group

  Pain interference mean score changes were compared between the two groups from baseline to 8 weeks using the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Scale.T-scores typically can range from 0 to 100, with "average" scores ranging from 41-59. No subscales are included in this measure. Higher scores indicate more pain interference (worse). A two-way repeated-measures analysis of covariance (ANCOVA) was used to examine changes between groups from baseline to the 8-week follow-up.

  Baseline and 8 weeks

Secondary Outcomes (9)

• Change in Quality of Life (QOL) for Physical Functioning

  Baseline and 8 weeks

• Mean Pain Acceptance Pre- and Post-treatment

  Baseline and 8 weeks

• Change in Disease-related Pain Severity and Overall Tumor Pain

  Baseline and 8 weeks

• Change in Quality of Life (QOL) for Daily Activities

  Baseline and 8 weeks

• Change in Disease-related Depression

  Baseline and 8 weeks

Other Outcomes (1)

• Number of Participants With Serious and/or Non-serious Adverse Events

  Baseline, and Week 8, 16, 32, and 40.

Study Arms (2)

1/Acceptance and Commitment Therapy (ACT) Group

EXPERIMENTAL

2 Acceptance and Commitment Therapy (ACT) Training Sessions followed by weekly emails and video chats.

Behavioral: Acceptance and Commitment Therapy (ACT)

2/Waitlist (WL) Group

ACTIVE COMPARATOR

Waitlist group - no intervention for first 8 weeks (then will receive Acceptance and Commitment Therapy (ACT) intervention as Arm 1)

Behavioral: Acceptance and Commitment Therapy (ACT)

Interventions

Acceptance and Commitment Therapy (ACT) BEHAVIORAL

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.

1/Acceptance and Commitment Therapy (ACT) Group; 2/Waitlist (WL) Group

Eligibility Criteria

• Age: 16 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients must be between 16 and 59 years of age at the time of the baseline assessment. Because the research on the effectiveness of Acceptance and Commitment Therapy (ACT) with younger children is still emerging, children 15 and younger will be excluded from the present study.
• Diagnosis of Neurofibromatosis Type 1 (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 (National Institutes of Health (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
• Participants must have documentation of a plexiform neurofibromas (PN), based on either clinical exam or imaging.
• 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).
• Patients must have regular access to a computer or tablet with internet access.
• Ability of subject or Legally Authorized Representative (LAR) to understand and the willingness to sign a written informed consent document.
• 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.
• 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.

You may not qualify if:

• In the opinion of the Principal Investigator (PI) or an Associate Investigator (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, specifically for pain management.
• Subjects who began a medical intervention for treatment of their disease that has a possible impact on pain (including Mitogen-activated Protein/Extracellular Signal-regulated Kinase Kinase (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.
• 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.

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 Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Neurofibromatosis 1; Neurofibroma, Plexiform

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Neurofibromatoses; 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; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Peripheral Nervous System Neoplasms; Nervous System Neoplasms

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Staci M. Peron, Ph.D.
• Organization: National Cancer Institute

martins@mail.nih.gov

240-760-6025

Study Officials

• Staci M Peron, Ph.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 15, 2015
• Study Start: July 7, 2015
• Primary Completion: December 23, 2020
• Study Completion: December 23, 2020
• Last Updated: June 14, 2022
• Results First Posted: December 6, 2021

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The protocol, SAP, and data will be shared when published on clinicaltrials.gov indefinitely.
• Access Criteria: http://yoda.yale.edu/

Locations

US (1)