BACKGROUND Mindfulness has been applied to improve cancer care by enhancing psychological well-being. However, little is known about its impact on cognitive impairment experienced by cancer patients after chemotherapy. Mindfulness may be relevant in tackling cognitive impairment by decreasing emotional distress and fatigue, by decreasing inflammation, and by strengthening functional brain connectivity. The aim of the present study protocol is to evaluate the efficacy and mechanisms of a mindfulness-based intervention to reduce cognitive impairment in breast cancer patients after chemotherapy. METHODS/DESIGN The present study is a three-arm, parallel-group, randomized controlled trial with assessments at baseline, 1 to 3 weeks after the intervention and at 3 months' follow-up. One hundred and twenty breast cancer patients who ended treatment a minimum of 6 months and a maximum of 5 years before, and who have cognitive complaints, will be enrolled. They will be randomized into one of the following three study arms: (1) a mindfulness-based intervention group (n = 40), (2) an active control condition based on physical training (n = 40), or (3) a treatment as usual (TAU) control group (n = 40). Both the mindfulness-based intervention and the active control condition consist of four group sessions (3 h for the mindfulness condition and 2 h for the physical training) spread over 8 weeks. The primary outcomes will be cognitive symptoms as measured by the Cognitive Failure Questionnaire and changes in functional brain connectivity in the attention network. Secondary outcomes will be (1) levels of emotional distress, fatigue, mindfulness, quality of life; (2) neurocognitive tests; (3) structural and functional brain changes using MR imaging and (4) measures of inflammation. DISCUSSION The study will examine the impact of a mindfulness-based intervention on cognitive impairment in breast cancer patients. If the findings of this study confirm the effectiveness of a mindfulness-based program to reduce cognitive impairment, it will be possible to improve quality of life for ex-cancer patients. We will inform health care providers about the potential use of a mindfulness-based intervention as a non-pharmaceutical, low-threshold mental health intervention to improve cognitive impairment after cancer. TRIAL REGISTRATION ClinicalTrials.gov, ID: NCT03736460. Retrospectively registered on 8 November 2018.

中文翻译：

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对化疗后认知障碍的乳腺癌患者进行基于正念的干预：三组随机对照试验的研究方案。


背景技术正念已被应用于通过增强心理健康来改善癌症护理。然而，人们对其对化疗后癌症患者认知障碍的影响知之甚少。正念可能通过减少情绪困扰和疲劳、减少炎症和加强大脑功能连接来解决认知障碍。本研究方案的目的是评估基于正念的干预措施的功效和机制，以减少乳腺癌患者化疗后的认知障碍。方法/设计本研究是一项三臂、平行组、随机对照试验，在基线、干预后 1 至 3 周以及 3 个月的随访时进行评估。将招募 120 名在至少 6 个月、最多 5 年前结束治疗且有认知问题的乳腺癌患者。他们将被随机分配到以下三个研究组之一：（1）基于正念的干预组（n = 40），（2）基于体能训练的主动控制条件组（n = 40），或（3）照常治疗 (TAU) 对照组 (n = 40)。基于正念的干预和主动控制条件均由四组课程组成（正念条件 3 小时，体能训练 2 小时），持续 8 周。主要结果将是通过认知失败问卷测量的认知症状以及注意力网络中功能性大脑连接的变化。次要结果是（1）情绪困扰、疲劳、正念、生活质量的水平； (2) 神经认知测试； (3) 使用 MR 成像进行大脑结构和功能的变化，以及 (4) 炎症测量。 讨论 该研究将探讨基于正念的干预对乳腺癌患者认知障碍的影响。如果这项研究的结果证实了基于正念的计划在减少认知障碍方面的有效性，那么就有可能改善癌症患者的生活质量。我们将向医疗保健提供者通报基于正念的干预措施作为非药物、低阈值心理健康干预措施的潜在用途，以改善癌症后的认知障碍。试验注册 ClinicalTrials.gov，ID：NCT03736460。追溯注册日期为2018年11月8日。