Acceptance and Commitment Therapy for Fatigue Interference in Advanced Gastrointestinal Cancer Patients and Caregiver Burden

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 晚期胃肠道（GI）癌症患者。由于疲劳干扰患者功能， 照料者经常报告说，他们感到责任越来越重。循证干预措施 缺乏解决癌症患者疲劳干扰和护理者负担的措施。在试点研究中， 承诺疗法（ACT）已经显示出减少与癌症相关的痛苦的潜力 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ACT干预措施 结合接受和正念练习（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。 这种基于电话的干预显示了强有力的可行性，可接受性和承诺， 减少疲劳对活动、情绪和认知的干扰。拟议的试验性研究是在此基础上进行的 以患者为中心的工作，以测试一种新的，二元ACT干预晚期GI癌症患者， 中重度疲劳干扰和家庭照顾者负担显著。在这次审判中， 将40名患者-护理人员配对以相同数量随机分配至ACT干预组或 教育/支持控制条件。两人在这两种情况下每周都会参加六次50分钟的电话会议 sessions.将在基线、干预后2周和干预后3个月评估结局。 我们将评估ACT改善患者疲劳的可行性、可接受性和初步疗效 干扰和照顾者负担。次要结局包括患者睡眠干扰和患者和 护理人员参与日常活动，心理灵活性和生活质量。我们亦会探讨 ACT对患者和照顾者身心健康服务使用的影响。研究结果将告知 R 01申请进行大规模干预效果试验。结果还将为以下方面奠定基础： 一项研究计划，重点是ACT的新应用，以症状干扰功能， 晚期癌症的护理负担。

Project Summary/Abstract Fatigue interference with activities, mood, and cognition is one of the most prevalent and distressing concerns of advanced gastrointestinal (GI) cancer patients. As fatigue interferes with patient functioning, family caregivers often report feeling burdened by increasing responsibilities. Evidence-based interventions addressing cancer patient fatigue interference and caregiver burden are lacking. 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 ACT intervention combining acceptance and mindfulness exercises (e.g., meditations, performing activities with greater awareness) with identification of personal values and engagement in activities consistent with these values. This telephone-based intervention showed strong evidence of feasibility, acceptability, and promise for reducing fatigue interference with activities, mood, and cognition. The proposed pilot study builds upon this patient-focused work to test a novel, dyadic ACT intervention for both advanced GI cancer patients with moderate-severe fatigue interference and their family caregivers with significant caregiving burden. In this trial, 40 patient-caregiver dyads will be randomly assigned in equal numbers to either the ACT intervention or an education/support control condition. Dyads in both conditions will attend six weekly 50-minute telephone sessions. Outcomes will be assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. We will evaluate the feasibility, acceptability, and preliminary efficacy of ACT on improving patient fatigue interference and caregiver burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily activities, psychological flexibility, and quality of life. We will also explore the effects of ACT on patient and caregiver physical and mental health service use. Study findings will inform an R01 application to conduct a large-scale trial of intervention efficacy. Results will also provide a foundation for a program of research focused on the novel application of ACT to symptom interference with functioning and caregiver burden in advanced cancer.