Mosher Catherine E, Secinti Ekin, Kroenke Kurt, Helft Paul R, Turk Anita A, Loehrer Patrick J, Sehdev Amikar, Al-Hader Ahmad A, Champion Victoria L, Johns Shelley A
Department of Psychology, Indiana University-Purdue University Indianapolis, 402 North Blackford Street, LD 124, Indianapolis, IN, 46202, USA.
Indiana University School of Medicine, Center for Health Services Research, Regenstrief Institute, 1101 W. 10th Street, Indianapolis, IN, 46202, USA.
Pilot Feasibility Stud. 2021 Apr 20;7(1):99. doi: 10.1186/s40814-021-00837-9.
Fatigue interference with activities, mood, and cognition is one of the most prevalent and bothersome 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 jointly addressing cancer patient fatigue interference and caregiver burden are lacking. In pilot studies, acceptance and commitment therapy (ACT) has shown promise for addressing symptom-related suffering in cancer patients. The current pilot trial seeks to test a novel, dyadic ACT intervention for both advanced GI cancer patients with moderate-to-severe fatigue interference and their family caregivers with significant caregiving burden or distress.
A minimum of 40 patient-caregiver dyads will be randomly assigned to either the ACT intervention or an education/support control condition. Dyads in both conditions attend six weekly 50-min telephone sessions. Outcomes are assessed at baseline as well as 2 weeks and 3 months post-intervention. We will evaluate the feasibility, acceptability, and preliminary efficacy of ACT for 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.
Findings will inform a large-scale trial of intervention efficacy. Results will also lay the groundwork for further novel applications of ACT to symptom interference with functioning and caregiver burden in advanced cancer.
ClinicalTrials.gov , NCT04010227 . Registered 8 July 2019.
疲劳对活动、情绪和认知的干扰是晚期胃肠道（GI）癌症患者最普遍且困扰的问题之一。由于疲劳会干扰患者的功能，家庭照顾者常常报告因责任增加而感到负担沉重。目前缺乏基于证据的联合解决癌症患者疲劳干扰和照顾者负担的干预措施。在试点研究中，接受与承诺疗法（ACT）已显示出在解决癌症患者症状相关痛苦方面的前景。当前的试点试验旨在测试一种新颖的、针对患有中度至重度疲劳干扰的晚期胃肠道癌症患者及其有显著照顾负担或困扰的家庭照顾者的二元ACT干预措施。
至少40对患者-照顾者二元组将被随机分配到ACT干预组或教育/支持对照组。两组均参加为期六周、每周一次、每次50分钟的电话会议。在基线以及干预后2周和3个月时评估结果。我们将评估ACT在改善患者疲劳干扰和照顾者负担方面的可行性、可接受性和初步疗效。次要结果包括患者睡眠干扰以及患者和照顾者在日常活动中的参与度、心理灵活性和生活质量。我们还将探讨ACT对患者和照顾者使用身心健康服务的影响。
研究结果将为大规模干预疗效试验提供信息。结果也将为ACT在晚期癌症中对功能症状干扰和照顾者负担的进一步新应用奠定基础。
ClinicalTrials.gov，NCT04010227。2019年7月8日注册。
