NCT02471339已完成3 期
Acceptance and Commitment Training for Adolescents and Young Adults With Neurofibromatosis Type 1, Plexiform Neurofibromas, and Chronic Pain: A Phase III Clinical Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Mean Pain Interference Mean Score Change From Baseline to 8 Weeks Between the Acceptance and Commitment Therapy Intervention Group and the Waitlist Group
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Mean Pain Interference Mean Score Change From Baseline to 8 Weeks Between the Acceptance and Commitment Therapy Intervention Group and the Waitlist Group
时间窗: Baseline and 8 weeks
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.
次要结局
- 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)
- Change in Pain-related Anxiety(Baseline and 8 weeks)
- Change in Heart Rate Variability (HRV)(Baseline and 8 weeks)
- Pain Interference Patient-Reported Outcomes Measurement Information System (PROMIS) II(Baseline and 8 weeks)
- Measure of Pain Inflexibility Pre- and Post-treatment(Baseline and 8 weeks)
研究者
Staci Peron, Ph.D.
Principal Investigator
National Cancer Institute (NCI)
研究点 (2)
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