Optimizing Psychological Treatment for Pain After Breast Cancer: A Factorial Design Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Pain intensity (11-point Numeric Rating Scale, NRS)
研究概览
简要总结
The present study aims to optimize psychological treatment for pain after breast cancer by identifying active treatment components. Specifically, a factorial design will be used to evaluate the efficacy and change processes of three psychological treatment components, which have been shown to be efficacious in the treatment of pain after breast cancer.
详细描述
There is a need for optimization of psychological treatment of pain after breast cancer. Optimization relies on knowledge about the active components of existing treatments. Guided by the Multiphase Optimization Strategy (MOST), the present study aims to address this challenge by identifying active contemporary cognitive behavioral therapy components for breast cancer-related pain. Consistent with the Optimization phase of the MOST framework, a full factorial design will be used to evaluate the efficacy and change processes of three selected treatment components.The overall hypothesis is that the three components will target key maintaining psychological factors in pain, thus leading to reductions in the primary outcomes of pain intensity and -interference. The treatment components and their hypothesized mechanisms of action are as follows:
- Mindful attention practices will increase attentional control (i.e., the ability to intentionally focus and intentionally shift one's attention), thereby reducing pain hypervigilance, leading to reductions in pain intensity and -interference.
- Decentering practices will reduce fusion with thoughts (i.e., getting caught up in one's thoughts, feelings and inner experiences), thereby reducing pain catastrophizing, leading to reductions in pain intensity and -interference.
- Values and committed action (i.e., behavior congruent with one's values) will increase acceptance of discomfort and reduce avoidant behavior, leading to reductions in pain intensity and -interference.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary breast cancer stage I-III
- •Min. 6 months post primary treatment (i.e., surgery, chemotherapy, and/or radiotherapy). Endocrine treatment, e.g., Letrozol or Tamoxifen, and/or Zoledronic acid and/or Herceptin treatment is allowed during study participation
- •Pain corresponding to a pain score of >= 3 on pain intensity and/or pain interference measured by 11-point Numeric Rating Scales (NRSs)
- •Sufficient ability to communicate in Danish
- •Sufficient ability to participate in an online-delivered intervention
排除标准
- •Non-curable breast cancer (stage IV)
- •Breast cancer recurrence
- •Bilateral breast cancer
- •Other current cancer disease
- •Other primary pain condition (e.g., fibromyalgia)
- •Current severe psychiatric disorder (e.g., psychosis) hindering study participation
- •Insufficient ability to communicate in Danish
- •Insufficient ability to participate in an online-delivered intervention
结局指标
主要结局
Pain intensity (11-point Numeric Rating Scale, NRS)
时间窗: Baseline (T1) to 1 week after last session (Post-intervention, T2)
The NRS is a validated, self-report instrument assessing pain intensity during the last week. Answer format range: 0 (no pain) to 10 (worst possible pain); total score range: 0-10. A higher score yields more pain.
Pain interference (the 7-item subscale of the Brief Pain Inventory, BPI)
时间窗: Baseline (T1) to 1 week after last session (Post-intervention, T2)
The BPI is a validated, self-report instrument assessing clinical pain. The BPI pain interference subscale assesses pain interference during the last week across 7 domains, i.e., general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Answer format range: 0 (no interference) to 10 (maximal interference); total score range: 0-10. A higher score yields more pain.
次要结局
- Pain intensity (11-point Numeric Rating Scale, NRS)(Every day for 6 days following the first session (Td) for each treatment component)
- Pain interference (the 7-item subscale of the Brief Pain Inventory, BPI)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Pain burden (11-point Numeric Rating Scale, NRS)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Well-being (the 5-item WHO-5 Well-Being Index, WHO-5)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Pain interference (1 aggregated item assessing pain interference during the last 24 hours within the 7 domains measured with the Brief Pain Inventory, BPI, interference subscale)(Every day for 6 days following the first session (Td) for each treatment component)
- Pain quality (the 22-item pain descriptors from the McGill Pain Questionnaire, MPQ)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Pain frequency (1 item)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Fear of cancer recurrence (the 9-item Fear of Cancer Recurrence Inventory, FCRI)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
- Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS)(Baseline (T1) to 12 weeks after post-intervention (T2) (Follow-up, T3))
研究者
Bobby Zachariae
Professor
University of Aarhus