Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain
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|ClinicalTrials.gov Identifier: NCT02471339|
Recruitment Status : Recruiting
First Posted : June 15, 2015
Last Update Posted : February 8, 2018
- 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.
- To see if Acceptance and Commitment Training improves pain coping in people with NF1 pain.
- People age 16 34 who have NF1, 1 or more PN tumors, and pain that interferes with their daily functioning.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Neurofibromatosis Type 1 Plexiform Neurofibromas||Other: Acceptance and Commitment Therapy (ACT)||Phase 3|
- 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
-To compare pain interference mean score changes from baseline to 8 weeks between the ACT intervention group and the waitlist (WL) group.
- Patients 16 - 59 years of age with a confirmed diagnosis of NF1 and >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.
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|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|
|Study Start Date :||June 1, 2015|
|Estimated Primary Completion Date :||January 31, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Other: Acceptance and Commitment Therapy (ACT)
- compare pain interference mean score changes from baseline to 8 weeks [ Time Frame: 8 weeks ]
- examine baseline to post-treatment changes in disease-related quality of life, pain severity, depression, pain-related anxiety, and heart rate variability (HRV) [ Time Frame: 8 weeks ]
- Compare groups in terms of pre-post changes in diseaserelated quality of life, pain severity, depression, pain-related anxiety, and HRV [ Time Frame: 8 weeks ]
- Examine the pattern of change from baseline to 8 weeks to 32weeks post-intervention [ Time Frame: 32 weeks ]
- Examine mediators between pre- and post-treatment paininterference [ Time Frame: 1.5 years ]
- Assess and compare the psychometric properties of the two pain interference measures (PII and PROMIS) [ Time Frame: 1.5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471339
|Contact: Staci M Peron, Ph.D.||(240) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Principal Investigator:||Staci M Peron, Ph.D.||National Cancer Institute (NCI)|