Acceptance and Commitment Therapy for Fatigue Interference in Metastatic Breast Cancer

项目总结/摘要 疲劳对活动、情绪和认知的干扰是最普遍和最令人担忧的问题之一 转移性乳腺癌患者。到目前为止，还没有基于证据的干预措施来减少疲劳 在转移性乳腺癌患者和其他晚期癌症人群中进行干预。在试点研究中， 接受和承诺疗法（ACT）已显示出减少与抑郁症相关的痛苦的潜力， 癌症患者。我们最近在转移性乳腺癌中进行了一项试点研究，测试了一种新的电话- 基于ACT的干预结合正念练习（例如，冥想，进行活动， 意识），识别个人价值观并参与与这些价值观一致的活动。 干预措施显示了强有力的证据，证明了减少 疲劳干扰活动、情绪和认知。拟议的第二阶段试验旨在更明确地 检查我们基于电话的ACT干预对转移性乳腺癌女性的疗效， 正在经历疲劳干扰在这项试验中，250名妇女将被随机分配到相同的数字， ACT干预或教育/支持控制条件。这两种情况下的妇女将参加六个 每周50分钟的电话会议。本研究的主要目的是测试基于电话的 疲劳干扰ACT。次要结果包括睡眠干扰，参与日常活动， 和生活质量。将在基线、干预后2周以及干预后3个月和6个月评估结局。 干预这项试验还将检查心理灵活性（定义为完全意识）是否增加 同时坚持与个人价值观相一致的行动，解释了有益的效果 ACT对疲劳干扰的影响在证明ACT的有效性后，干预措施可以广泛应用。 扩散到转移性乳腺癌患者。这次试验也将为进一步应用奠定基础 并在广泛的癌症人群和功能结果中测试ACT。

Project Summary/Abstract Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of metastatic breast cancer patients. To date, there are no evidence-based interventions for reducing fatigue interference in metastatic breast cancer patients and other advanced cancer populations. In pilot studies, Acceptance and Commitment Therapy (ACT) has shown potential for reducing symptom-related suffering in cancer patients. We recently conducted a pilot study in metastatic breast cancer that tested a novel telephone- based ACT intervention combining mindfulness exercises (e.g., meditations, performing activities with greater awareness) with identification of personal values and engagement in activities consistent with these values. The intervention showed strong evidence of feasibility, acceptability, and promise with respect to reducing fatigue interference with activities, mood, and cognition. The proposed Phase II trial seeks to more definitively examine the efficacy of our telephone-based ACT intervention for women with metastatic breast cancer who are experiencing fatigue interference. In this trial, 250 women will be randomly assigned in equal numbers to either the ACT intervention or an education/support control condition. Women in both conditions will attend six weekly 50-minute telephone sessions. The primary aim of this study is to test the effect of telephone-based ACT on fatigue interference. Secondary outcomes include sleep interference, engagement in daily activities, and quality of life. Outcomes will be assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post- intervention. This trial will also examine whether increases in psychological flexibility, defined as full awareness of the present moment while persisting in action aligned with personal values, account for the beneficial effect of ACT on fatigue interference. After demonstrating ACT's efficacy, the intervention can be widely disseminated to metastatic breast cancer patients. This trial will also lay the groundwork for further application and testing of ACT with a wide range of cancer populations and functional outcomes.