Efficacy of MBSR Treatment of Cognitive Impairment Among Breast Cancer Survivors

 描述（由申请人提供）：由于检测和治疗的改善，乳腺癌幸存者（BSC）的生存率有所提高。然而，BCS在治疗后可能会出现认知障碍（CI），BCS在化疗（CT）后长达10年的时间内报告了这一情况。关于减压干预是否能改善平衡计分卡中的认知能力的证据有限.本申请的主要目标是建立基于正念的乳腺癌减压（MBSR（BC））计划，作为BCS中CI的有效治疗方法。具体来说，我们的目标是（1）评估与乳腺癌教育支持（BCES）计划或常规护理（UC）相比，正念减压疗法（BC）在多大程度上改善了停止治疗的乳腺癌患者的认知功能;（2）确定正念减压疗法（BC）获得的认知功能改善是否是通过增加正念、减少沉思和压力来介导的;（3）评估基因变异作为MBSR（BC）改善CI的调节因子;（4）确定MBSR（BC）对医疗保健利用和成本的影响。 为了实现这些目标，我们将在330例接受辅助CT或CT和放疗的I-III期BC BCS中进行随机对照试验（RCT）。在本随机对照试验中，MBSR（BC）将用于讲西班牙语的BCS亚群。参与者将以1：1：1的比例随机分配到（1）6周MBSR（BC）计划;（2）6周BCES计划;或（3）UC。BCES计划将在时间和注意力方面与MBSR（BC）计划相匹配，并与MBSR（BC）的小组支持部分相平行。评估将在基线、6周、12周和6个月时进行，包括临床病史和人口统计学信息、客观神经心理学评估、主观认知和症状测量、成本利用调查和用于遗传分析的血液样本采集。 本研究具有高度的创新性，是第一个随机试验：1）评估MBSR（BC）在BCS中客观神经心理学和认知功能主观改善的疗效; 2）评估MBSR（BC）改善CI的调节因子的遗传特征; 3）提供MBSR试验的西班牙语和英语，以改善认知;（4）在与卫生服务利用费用相关的BCS中，确定MBSR（BC）对CT诱发的CI的影响。 MBSR（BC）通过自我调节对压力事件的注意力和意识，提供促进减压的培训。我们的初步结果表明，MBSR（BC）改善主观认知功能。如果MBSR（BC）被发现是有效的，它将提供证据， 一种可行的非药物方法来管理BCS中的CI。此外，假设的介质的影响的检查可能会产生新的见解定制MBSR（BC）和/或开发额外的干预措施，以帮助BCS。评估遗传多态性以探索风险等位基因是否与认知功能的改善相关，这可能表明特定的遗传特征可能会改变接受MBSR（BC）的患者的CI改善。最后，如果MBSR（BC）被证明是有效的，这可能会显着影响医疗保健利用率 并为临床医生、研究人员和决策者提供必要的证据。

 DESCRIPTION (provided by applicant): Due to improved detection and treatment, survival rates among breast cancer survivors (BSC) have increased. However, BCS may experience cognitive impairment (CI) following treatment, which has been reported by BCS up to 10 years after chemotherapy (CT). There is limited evidence on whether stress- reducing interventions improve CI in BSC. The primary goal of this application is to establish the Mindfulness- Based Stress Reduction for Breast Cancer (MBSR(BC)) program as an effective treatment for CI in BCS. Specifically we aim to (1) evaluate the extent to which MBSR(BC) compared to the Breast Cancer-Education Support (BCES) program or Usual Care (UC) improves cognitive functioning among BCS off treatment; (2) determine if improvements in cognitive functioning achieved from MBSR(BC) are mediated through increased mindfulness and decreased rumination and stress; (3) evaluate genetic variants as moderators of MBSR(BC) on improvements in CI; and (4) determine the impact of MBSR(BC) on healthcare utilization and costs. To achieve these aims, we will conduct a randomized controlled trial (RCT) among 330 BCS with Stage I-III BC who have received adjuvant CT or CT and radiation. Within this RCT, MBSR(BC) will be delivered to a subpopulation of Spanish speaking BCS. Participants will be randomly assigned in a 1:1:1 ratio to (1) the 6- week MBSR(BC) program; (2) the 6-week BCES program; or (3) UC. The BCES program will match the MBSR(BC) program for time and attention and parallel the group support component of MBSR(BC). Assessments will take place at baseline, 6 weeks,12 weeks and 6 months and include clinical history and demographic information, objective neuropsychological assessments, subjective cognitive and symptom measurements, cost utilization surveys and a blood sample collection for genetic analyses. This study is highly innovative to be the first randomized trial to: 1) evaluate the efficacy of MBSR(BC) among BCS for objective neuropsychological and subjective improvements in cognitive functioning; 2) evaluate genetic profiles as moderators of MBSR(BC) on improving CI; 3) offer the MBSR trial in Spanish in addition to English for the purpose of improving cognition; and 4) determine the effect of MBSR(BC) on CT-induced CI among BCS related to health service utilization costs. MBSR(BC) provides training to promote stress reduction through self-regulation of attention and awareness to stressful events. Our preliminary results show that MBSR(BC) improves subjective cognitive functioning. If MBSR(BC) is found to be effective, it will provide evidence of a viable non-pharmacological method for managing CI in BCS. Additionally, the examination of the effects of the hypothesized mediators may yield new insights for tailoring MBSR(BC) and/or developing additional interventions to aid BCS. The assessment of genetic polymorphisms to explore if risk alleles are associated with improvement in cognitive functioning may demonstrate that specific genetic profiles may modify improvements in CI for those receiving MBSR(BC). Finally, if MBSR(BC) is shown to be effective, this may significantly impact healthcare utilization and cost and produce necessary evidence for clinicians, researchers and policymakers.