Optimization of Psychological Treatment for Pain After Breast Cancer Using the Multiphase Optimization Strategy (MOST): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 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 is a pilot study that aims to evaluate the feasibility, validity, and preliminary efficacy of three psychological treatment components for pain after breast cancer, which will be evaluated in a larger trial following completion of the present pilot study.
详细描述
The present pilot study is a precursor for a following larger trial and aims to evaluate the i) feasibility, ii) validity, and iii) preliminary efficacy of the three treatment components that will be further investigated in a subsequent larger trial. The present pilot study will employ the same design as will be used in the subsequent larger trial, namely the Multiphase Optimization Strategy (MOST). Specifically, in the subsequent larger trial, MOST will be used to evaluate the efficacy and change processes of three psychological treatment components selected from so-called "third wave" cognitive therapies (CTs), which have been shown to be efficacious in the treatment of pain after breast cancer.
The overall hypothesis is that the selected third wave CT components will target key maintaining psychological factors in pain, thus leading to reductions in the primary outcomes of pain intensity and -interference. Specifically, we hypothesize that:
- 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 and acting automatically in response to thoughts), thereby reducing pain catastrophizing, leading to reductions in pain intensity and -interference.
- Values and committed action (i.e., behavior linked to values and goals) 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
- 未提供
排除标准
- •Metastatic breast cancer (stage IV)
- •Breast cancer recurrence
- •Bilateral breast cancer
- •Other current cancer disease
- •Other current pain condition (e.g., fibromyalgia)
- •Current severe psychiatric disorder (e.g., psychosis)
- •Inability to communicate in Danish
- •Inability 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. Higher scores yield 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. Higher scores yield more pain interference.
次要结局
- 4. 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 1 week after last session (Post-intervention, T2))
- Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS)(Baseline (T1) to 1 week after last session (Post-intervention, T2))
- Pain intensity (11-point Numeric Rating Scale, NRS)(Every day for 6 days following the first session (Td) for each treatment component)
- Pain catastrophizing (the 13-item Pain Catastrophizing Scale, PCS)(Baseline (T1) to 1 week after last session (Post-intervention, T2))
- Pain burden (11-point Numeric Rating Scale, NRS)(Baseline (T1) to 1 week after last session (Post-intervention, T2))
- Fear of cancer recurrence (the 9-item Fear of Cancer Recurrence Inventory, FCRI)(Baseline (T1) to 1 week after last session (Post-intervention, T2))
- Well-being (the 5-item WHO-5 Well-Being Index, WHO-5)(Baseline (T1) to 1 week after last session (Post-intervention, T2))
研究者
Maja Johannsen
Assistant Professor
University of Aarhus