Optimizing Psychological Treatment for Pain After Breast Cancer: A Pilot Study
2021年9月29日 更新者：Maja Johannsen、University of Aarhus
Optimization of Psychological Treatment for Pain After Breast Cancer Using the Multiphase Optimization Strategy (MOST): A Pilot Study
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
31
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Central Denmark Region
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Aarhus、Central Denmark Region、丹麦、8000
- Aarhus University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
描述
Inclusion criteria:
- Diagnosis of primary breast cancer stage I-III
- Min. 6 months post breast cancer treatment (i.e., surgery, chemotherapy, and/or radiotherapy). Endocrine treatment, e.g., Letrozole or Tamoxifen, and/or Zoledronic acid and/or Herceptin treatment is allowed during study participation
- Pain corresponding to a min. pain score of >= 3 on pain intensity 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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无干预：候补名单控制
随机分配到条件 1 的参与者在入组后不会立即获得任何治疗成分，但会在研究结束时获得自己选择的治疗成分。
会话总数：研究完成后 2（2 个接触小时）。
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实验性的：正念关注
随机分配到条件 2 的参与者将接受正念注意力治疗部分。
会话总数：2（2 个接触小时）。
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正念注意力治疗部分由呼吸练习组成，分为两节课（每节课 1 小时），为期两周，即每周一节课，课间作业。
会议将在线提供。
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实验性的：去中心化
随机分配到条件 3 的参与者将接受偏心治疗部分。
会话总数：2（2 个接触小时）。
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偏心治疗部分包括一个引导性的意象练习，并在两周内分两次（每次 1 小时）进行操作，即每周一次，课间作业。
会议将在线提供。
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实验性的：价值观和承诺的行动
随机分配到条件 4 的参与者将接受价值观和承诺行动治疗部分。
会话总数：2（2 个接触小时）。
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The Values and committed action treatment component consists of identification of personal values and committed action, and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions.
Sessions will be delivered online.
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实验性的：Mindful attention + Decentering
Participants randomized to condition 5 will receive the Mindful attention treatment component and the Decentering treatment component.
Total number of sessions: 4 (4 contact hours).
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正念注意力治疗部分由呼吸练习组成，分为两节课（每节课 1 小时），为期两周，即每周一节课，课间作业。
会议将在线提供。
偏心治疗部分包括一个引导性的意象练习，并在两周内分两次（每次 1 小时）进行操作，即每周一次，课间作业。
会议将在线提供。
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实验性的：Mindful attention + Values and committed action
Participants randomized to condition 6 will receive the Mindful attention treatment component and the Values and committed action treatment component.
Total number of sessions: 4 (4 contact hours).
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正念注意力治疗部分由呼吸练习组成，分为两节课（每节课 1 小时），为期两周，即每周一节课，课间作业。
会议将在线提供。
The Values and committed action treatment component consists of identification of personal values and committed action, and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions.
Sessions will be delivered online.
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实验性的：Decentering + Values and committed action
Participants randomized to condition 7 will receive the Decentering treatment component and the Values and committed action treatment component.
Total number of sessions: 4 (4 contact hours).
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偏心治疗部分包括一个引导性的意象练习，并在两周内分两次（每次 1 小时）进行操作，即每周一次，课间作业。
会议将在线提供。
The Values and committed action treatment component consists of identification of personal values and committed action, and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions.
Sessions will be delivered online.
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实验性的：Mindful attention + Decentering + Value-based action
Participants randomized to condition 8 will receive the Mindful attention treatment component, the Decentering treatment component, and the Values and committed action treatment component.
Total number of sessions: 6 (6 contact hours).
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正念注意力治疗部分由呼吸练习组成，分为两节课（每节课 1 小时），为期两周，即每周一节课，课间作业。
会议将在线提供。
偏心治疗部分包括一个引导性的意象练习，并在两周内分两次（每次 1 小时）进行操作，即每周一次，课间作业。
会议将在线提供。
The Values and committed action treatment component consists of identification of personal values and committed action, and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions.
Sessions will be delivered online.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Pain intensity (11-point Numeric Rating Scale, NRS)
大体时间：Baseline (T1) to 1 week after last session (Post-intervention, T2)
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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.
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Baseline (T1) to 1 week after last session (Post-intervention, T2)
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Pain interference (the 7-item subscale of the Brief Pain Inventory, BPI)
大体时间：Baseline (T1) to 1 week after last session (Post-intervention, T2)
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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.
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Baseline (T1) to 1 week after last session (Post-intervention, T2)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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疼痛质量（来自麦吉尔疼痛问卷 MPQ 的 22 项疼痛描述符）
大体时间：基线 (T1) 至最后一次会议后 1 周（干预后，T2）
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来自 MPQ 的疼痛描述符构成了一个经过验证的自我报告工具，用于评估上周的疼痛质量（即疼痛类型，即持续性疼痛、间歇性疼痛、神经性疼痛、情感性疼痛）。
答案格式范围：0（无痛）至 10（最痛）；总分范围：0-60（持续性、神经性和间歇性疼痛），0-40（情感性疼痛）。
更高的分数产生更多的痛苦。
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基线 (T1) 至最后一次会议后 1 周（干预后，T2）
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疼痛灾难化（13 项疼痛灾难化量表，PCS）
大体时间：基线 (T1) 至最后一次会议后 1 周（干预后，T2）
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PCS 是一种经过验证的自我报告工具，用于评估疼痛灾难化。
答案格式范围：0（一点也不）到4（一直）；总分范围：0-52。
较高的分数会产生更多的痛苦灾难。
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基线 (T1) 至最后一次会议后 1 周（干预后，T2）
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对癌症复发的恐惧（9 项癌症复发恐惧量表，FCRI）
大体时间：基线 (T1) 至最后一次会议后 1 周（干预后，T2）
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FCRI 是一种经过验证的自我报告工具，用于评估上个月对癌症复发的恐惧。
答案格式范围：0（一点也不）到4（很多）；总分范围0-36。
分数越高，对癌症复发的恐惧就越大。
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基线 (T1) 至最后一次会议后 1 周（干预后，T2）
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幸福感（5 项 WHO-5 幸福感指数，WHO-5）
大体时间：基线 (T1) 至最后一次会议后 1 周（干预后，T2）
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WHO-5 是一种经过验证的自我报告工具，用于评估当前的福祉。
答案格式范围：0（从来没有）到5（一直）；总分范围：0-100。
更高的分数会带来更多的幸福感。
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基线 (T1) 至最后一次会议后 1 周（干预后，T2）
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Pain intensity (11-point Numeric Rating Scale, NRS)
大体时间：Every day for 6 days following the first session (Td) for each treatment component
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Pain intensity during the last 24 hours will be assessed every day for 6 days following the first session (Td) for each treatment component using the NRS.
Answer format range: 0 (no pain) to 10 (worst possible pain); total score range: 0-10.
Higher scores yield more pain.
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Every day for 6 days following the first session (Td) for each treatment component
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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)
大体时间：Every day for 6 days following the first session (Td) for each treatment component
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Pain interference during the last 24 hours will be assessed every day for 6 days following the first session (Td) for each treatment component using 1 aggregated item assessing pain interference across the 7 domains measured with the BPI interference subscale, 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.
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Every day for 6 days following the first session (Td) for each treatment component
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Pain burden (11-point Numeric Rating Scale, NRS)
大体时间：Baseline (T1) to 1 week after last session (Post-intervention, T2)
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The NRS is a validated, self-report instrument assessing pain burden during the last week.
Answer format range: 0 (no burden) to 10 (maximal burden); total score range: 0-10.
Higher scores yield more pain burden.
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Baseline (T1) to 1 week after last session (Post-intervention, T2)
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Psychological distress (the 14-item Hospital Anxiety and Depression Scale, HADS)
大体时间：Baseline (T1) to 1 week after last session (Post-intervention, T2)
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The HADS is a validated, self-report instrument assessing psychological distress during the last week.
Answer format range: 0 (not at all or never) to 3 (most or all of the time); total score range 0-42.
Higher scores yield more distress.
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Baseline (T1) to 1 week after last session (Post-intervention, T2)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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主持人：治疗联盟（12 项工作联盟清单，WAI）修订简表
大体时间：最后一次会议后 1 周（干预后，T2）
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WAI 是一种经过验证的自我报告评估治疗联盟的工具。
答案格式范围：1（从不）到7（一直）；总分范围：12-84。
更高的分数产生更强的治疗联盟。
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最后一次会议后 1 周（干预后，T2）
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中介：正念注意（15 项正念注意意识量表，MAAS）
大体时间：基线 (T1) 至最后一次会议后 1 周（干预后，T2）
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MAAS 是一种经过验证的自我报告工具，用于评估随时间推移的正念状态频率的个体差异。
答案格式范围：1（几乎总是）到 6（几乎从不）；总分范围：1-6。
更高的分数会产生更高水平的注意力。
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基线 (T1) 至最后一次会议后 1 周（干预后，T2）
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中介：正念注意（来自 15 项正念注意意识量表，MAAS 的 2 项）
大体时间：在每个会话之前 (Ts)
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MAAS 项目 13 和 7 将在每次会议 (Ts) 之前进行评估。
答案格式范围：1（几乎总是）到 6（几乎从不）。
更高的分数会产生更高水平的注意力。
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在每个会话之前 (Ts)
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中介：疼痛接受度和活动参与度（20 项慢性疼痛接受量表，CPAS）
大体时间：基线 (T1) 至最后一次会议后 1 周（干预后，T2）
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CPAS 是一种经过验证的自我报告工具，用于评估疼痛接受度和活动参与度。
答案格式范围：0（从不为真）到 6（总是为真）；子量表得分范围：0-54（疼痛接受子量表），0-66（活动参与子量表）。
更高的分数会产生更多的接受度和活动参与度。
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基线 (T1) 至最后一次会议后 1 周（干预后，T2）
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Qualitative Interviews
大体时间：10-14 days after last session
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Participants will be invited to participate in a 30-minutes semi-structured individual interview 10-14 days after their last session.
The interview serves to support the validation of the treatment components and to provide in-depth knowledge about the participants' experiences through their qualitative comments.
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10-14 days after last session
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Moderator: Demographic characteristics
大体时间：Baseline (T1)
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Socio-demographic characteristics will be assessed using single questions (e.g., municipality, marital status, income, work status).
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Baseline (T1)
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Moderator: Clinical characteristics
大体时间：Baseline (T1)
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Clinical characteristics will be assessed using single questions (e.g., date of surgery, adjuvant therapy).
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Baseline (T1)
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Moderator: Treatment expectancy
大体时间：Baseline (T1)
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Treatment expectancy will be assessed using a single question regarding the extent to which the participant believes that the intervention will reduce pain and increase overall well-being.
Answer format range: 1 (not at all) to 5 (a great deal); total score range: 1-5.
Higher scores indicate stronger expectations that the intervention will lead to a positive outcome.
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Baseline (T1)
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Moderator: Home work
大体时间：Before each session (Ts) and 1 week after last session (Post-intervention, T2)
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Homework will be assessed with 4 single items related to i) whether home work has been conducted (yes/no), and the ii) type, iii) frequency (number of days per week), and iv) duration of completed homework (average number of minutes per day).
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Before each session (Ts) and 1 week after last session (Post-intervention, T2)
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Mediator: Mindful attention (1 item from the 15-item Mindful Attention Awareness Scale, MAAS)
大体时间：Every day for 6 days following the first session for each treatment component (Td)
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MAAS item 6 will be assessed every day for 6 days following the first session (Td) for each treatment component.
Answer format range: 1 (almost always) to 6 (almost never).
Higher scores yield higher levels of mindful attention.
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Every day for 6 days following the first session for each treatment component (Td)
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Mediator: Decentering (the 11-item subscale of the Experiences Questionnaire, EQ)
大体时间：Baseline (T1) to 1 week after last session (Post-intervention, T2)
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The EQ is a validated, self-report instrument assessing decentering.
Answer format range: 1 (do not agree at all) to 5 (agree completely); total score range: 11-55.
Higher scores yield higher levels of decentering.
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Baseline (T1) to 1 week after last session (Post-intervention, T2)
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Mediator: Decentering (2 items from the 11-item subscale of the Experiences Questionnaire, EQ)
大体时间：Before each session (Ts)
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EQ items 5 and 7 will be assessed before each session (Ts).
Answer format range: 1 (do not agree at all) to 5 (agree completely).
Higher scores yield higher levels of decentering.
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Before each session (Ts)
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Mediator: Decentering (1 item from the 11-item subscale of the Experiences Questionnaire, EQ)
大体时间：Every day for 6 days following the first session for each treatment component (Td)
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EQ item 5 will be assessed every day for 6 days following the first session (Td) for each treatment component.
Answer format range: 1 (do not agree at all) to 5 (agree completely).
Higher scores yield higher levels of decentering.
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Every day for 6 days following the first session for each treatment component (Td)
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Mediator: Pain acceptance and activity engagement (2 items from the 20-item Chronic Pain Acceptance Scale, CPAS)
大体时间：Before each session (Ts)
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CPAS items 1 and 12 will be assessed before each session (Ts).
Answer format range: 0 (never true) to 6 (always true).
Higher scores yield more acceptance and activity engagement.
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Before each session (Ts)
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Mediator: Pain acceptance and activity engagement (1 item from the 20-item Chronic Pain Acceptance Scale, CPAS)
大体时间：Every day for 6 days following the first session for each treatment component (Td)
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CPAS item 1 will be assessed every day for 6 days following the first session (Td) for each treatment component.
Answer format range: 0 (never true) to 6 (always true).
Higher scores yield more acceptance and activity engagement.
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Every day for 6 days following the first session for each treatment component (Td)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Maja Johannsen, PhD、University of Aarhus
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年3月1日
初级完成 (实际的)
2021年7月1日
研究完成 (实际的)
2021年8月1日
研究注册日期
首次提交
2021年3月23日
首先提交符合 QC 标准的
2021年4月9日
首次发布 (实际的)
2021年4月12日
研究记录更新
最后更新发布 (实际的)
2021年9月30日
上次提交的符合 QC 标准的更新
2021年9月29日
最后验证
2021年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.