Efficacy and Mechanistic Testing of a Self-Management Intervention for Managing Chronic Pain With Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 4
- 主要终点
- Change in Pain Intensity
研究概览
简要总结
Cancer survivors who suffer from chronic pain would benefit from a low-cost, self-management intervention they can use at home. This study will evaluate the efficacy of a recorded hypnosis intervention in reducing chronic pain among cancer survivors and will explore its biological and psychological mechanisms.
详细描述
The purpose of this randomized controlled trial is to evaluate if a 4-week recorded hypnosis intervention (RHI) works for reducing chronic pain in 100 adult cancer survivors who have completed active treatment. The RHI will be compared to an attention control condition (relaxation recording). qEEG measurement will be obtained while listening to the RHI at weeks 0, 2, and 4 to explore if brain states are related to hypnotic analgesia during the 4-week study period in 20 study participants.
The study has the following specific aims:
Aim 1: Does the RHI work? Evaluate the efficacy of RHI in reducing self-reported pain intensity (primary outcome), pain interference, anxiety, depression, fatigue and sleep disturbance (secondary outcomes) at 4 weeks compared to the attention control condition (relaxation recording). Hypothesis: RHI will significantly reduce pain intensity, pain interference, anxiety, depression, fatigue, and sleep disturbance at 4 weeks.
Aim 2: For whom does the RHI work? Examine if psychological factors (hypnotic suggestibility, mental absorption, treatment outcome expectancy, fear of cancer recurrence, resilience, self-efficacy) influence the relationship between RHI and pain intensity at weeks 0, 2, and 4.
Aim 3: How does the RHI work? a. Compare brain activity as measured by electroencephalogram (EEG) in cancer survivors with chronic pain (n=30) receiving the RHI relative to the attention control condition (relaxation recording) at weeks 0, 2, and 4. b. Explore the effects of brain activity on pain intensity at weeks 0, 2, and 4. In addition, structured interviews will be conducted with participants to understand facilitators and barriers associated with undergoing EEG at three time points and perceptions on how the intervention works to reduce pain.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •self-reporting moderate or higher pain on average during the last week (> 3 on a 0-10 pain intensity numeric scale)
- •self-reporting experiencing pain at least half of the days in the past 4 weeks
- •self-reporting chronic pain related to cancer or its treatment
- •completed active cancer treatment other than maintenance therapy
- •being > 18 years of age
- •functional fluency in English
- •mentally and physically able to participate and complete surveys
排除标准
- •has a psychiatric condition or symptoms (i.e., diagnosis of paranoid schizophrenia or active paranoid delusional thoughts, as determined via a telephone or in-person screening assessment) that would interfere with study participation.
- •Exclusion Criteria for Optional EEG Measurement:
- •a history of seizure condition within the last year
- •a significant brain injury or skull defect
- •a history of brain cancer.
结局指标
主要结局
Change in Pain Intensity
时间窗: Pre- to Post-treatment (4 weeks)
The Patient Reported Outcomes Measurement Information System® (PROMIS®) v.1.0, 1a - Pain Intensity; minimum value 0, maximum value 10; a lower score indicates a better outcome. A change between pre-treatment (baseline) and post-treatment (4 weeks) scores is reported.
次要结局
- Change in Depression(Pre- to Post-treatment (4 weeks))
- Change in Fatigue(Pre- to Post-treatment (4 weeks))
- Change in Sleep Disturbance(Pre- to Post-treatment (4 weeks))
- Change in Pain Interference(Pre- to Post-treatment (4 weeks))
- Change in Anxiety(Pre- to Post-treatment (4 weeks))
研究者
Linda Eaton
Assistant Professor
University of Washington