Acceptance and Commitment Therapy for Fear of Recurrence in Breast Cancer Survivors

项目摘要/摘要 在接受早期癌症治疗后，大多数幸存者担心复发的可能性。虽然温和而温和 对于许多人来说，这些恐惧是间歇性的，对于大约40%的幸存者来说，这些恐惧变得具有临床意义，对他们来说是不利的 影响情绪、应对和生活质量，同时增加医疗保健使用量和相关 成本。尤其脆弱的是乳腺癌幸存者(BC)，他们临床报告的可能性高出33%。 与其他幸存者相比，他们对癌症复发(FCR)的严重恐惧。此外，FCR是最未得到满足的需求 然而，在BCS中，缺乏对FCR的循证治疗。认知行为疗法有 是对FCR进行最频繁测试的干预措施，产生的效果不大。一个理论上截然不同的 更适合BCS的FCR经验的方法是接受和承诺疗法 (表演)。ACT的目标是增加心理灵活性，从而使困难的内部体验(例如，恐惧 思想和感受)较少干扰有意义的活动和生活质量。心理灵活性是 包括正念/接受过程(即，对当下的同情关注)和 承诺/行为改变过程(即，确定并按照个人价值观行事)。我们的团队 在BCS和临床FCR中进行了一项三组试点随机对照试验，比较了基于组的ACT和 关注匹配的生存教育(SE)组和增强型日常护理(EUC；简要指导 自我管理的读数)。快速招聘(12周内招聘91人)和高留职率(94.5%至6%) 几个月)证明了突出的可行性。我们6周的ACT干预在以下方面优于SE和EUC 在干预后6个月，降低FCR并改善其他几个结果。基于这些有希望的 先导试验结果，我们提出了一项ACT与CBT和EUC比较的3 ARM III期随机对照试验 对于早期(I-IIIA)BCS，治疗后0-5年(N=375)报告有临床意义的FCR。全 发言将通过视频会议进行。使用印第安纳州癌症登记处和印第安纳州 患者护理数据库网络，我们将从五个肿瘤学机构招募BCS，其中包括一个 专门照顾不同种族、民族和经济状况的幸存者。具体目标是：(1)测试 基于小组的ACT与CBT和EUC在FCR(主要结果)和焦虑方面的疗效比较， 12岁以上的抑郁症状、创伤后应激、回避性应对和生活质量(次要结果) (2)检查心理灵活性的变化，作为ACT对12个月FCR影响的中介； (3)对ACT、CBT和EUC进行比较评估，以确定成本效益干预措施 对于FCR。我们证明ACT疗效的能力将使其广泛传播到BCS。发现 还将为ACT在不同癌症人群和健康人群中的进一步应用和改进测试提供信息- 相关结果。

PROJECT SUMMARY / ABSTRACT Following treatment for early-stage cancer, most survivors fear the possibility of a recurrence. While mild and intermittent for many, these fears become clinically significant for approximately 40% of survivors, adversely affecting mood, coping, and quality of life while simultaneously increasing healthcare use and associated costs. Particularly vulnerable are breast cancer survivors (BCS) who are 33% more likely to report clinically significant fear of cancer recurrence (FCR) than other survivors. Additionally, FCR is the top unmet need among BCS, yet evidence-based treatments for FCR are lacking. Cognitive Behavioral Therapy (CBT) has been the most frequently tested intervention for FCR, yielding modest effect sizes. A theoretically distinct approach that may be better suited to BCS' experiences with FCR is Acceptance and Commitment Therapy (ACT). The goal of ACT is to increase psychological flexibility so that difficult internal experiences (e.g., fearful thoughts and feelings) interfere less with meaningful activities and quality of life. Psychological flexibility is comprised of mindfulness/acceptance processes (i.e., compassionate attention to the present moment) and commitment/behavior change processes (i.e., identifying and acting in line with personal values). Our team conducted a 3-arm pilot randomized controlled trial in BCS with clinical FCR comparing group-based ACT to an attention-matched survivorship education (SE) group and enhanced usual care (EUC; brief coaching with self-administered readings). Rapid recruitment (91 BCS in 12 weeks) and high retention (94.5% through 6 months) demonstrated outstanding feasibility. Our 6-week ACT intervention was superior to SE and EUC in reducing FCR and improving several other outcomes at 6 months post-intervention. Based on these promising pilot trial results, we propose a 3-arm phase III randomized controlled trial of ACT compared to CBT and EUC for early stage (I-IIIA) BCS 0-5 years post-treatment (N=375) reporting clinically significant FCR. All interventions will be delivered via videoconferencing. Using the Indiana State Cancer Registry and Indiana Network for Patient Care database, we will recruit BCS from five oncology facilities, including one that specializes in the care of racially, ethnically, and economically diverse survivors. Specific aims are to: (1) test the efficacy of group-based ACT compared to CBT and EUC on FCR (primary outcome) and anxiety, depressive symptoms, post-traumatic stress, avoidant coping, and quality of life (secondary outcomes) over 12 months; (2) examine change in psychological flexibility as a mediator of ACT's effects on FCR over 12 months; and (3) perform comparative assessment of ACT, CBT, and EUC to determine the cost-effective intervention for FCR. Our ability to demonstrate ACT's efficacy will lead to its widespread dissemination to BCS. Findings will also inform further application and refined testing of ACT with various cancer populations and health- related outcomes.