Williams Lauren K, Ftanou Maria, Pearson Elizabeth J
Department of Health Services Research, Peter MacCallum Cancer Centre, Level 4, 535 Elizabeth Street, Melbourne, Victoria, 3000, Australia.
Department of Psychology, Peter MacCallum Cancer Centre, 305 Grattan Street, Melbourne, Victoria, 3000, Australia.
Pilot Feasibility Stud. 2022 May 27;8(1):112. doi: 10.1186/s40814-022-01062-8.
Cancer-related fatigue (CRF) is a commonly experienced and often debilitating side effect of cancer treatment that can persist for years after treatment completion. The benefits of cognitive behaviour therapy (CBT) for CRF are well established; however, these interventions are typically not included in standard clinical care. Traditional CBT is resource-intensive, limiting implementation in hospital settings. Stepped-care approaches can offer benefits to more people, using the same personnel as traditional models.
METHOD/DESIGN: This is a single-arm feasibility study. Fifty people with a cancer diagnosis, at least 12 weeks post-treatment or on long-term maintenance treatment, with persistent CRF that is affecting daily activities, will enrol in a stepped-care CBT program.
The stepped-care program involves two steps. Step 1: All participants begin with a 5-week supported self-management CBT progam targeting fatigue. Step 2: If fatigue remains severe or has changed less than the minimal clinically important difference on the fatigue measure after step 1, participants will be offered four sessions of therapist-directed group CBT.
Participants will complete questionnaires at baseline and 6 and 10 weeks. The primary outcome is feasibility of the REFRESH program. The implementation evaluation comprises acceptability, satisfaction, appropriateness, and feasibility of the study intervention, along with administrative data including cost, processes, procedures and implementation. Secondary outcomes are changes in fatigue, quality of life and self-efficacy.
The REFRESH program will be the first stepped-care CBT intervention for persistent CRF in Australia. Assessing feasibility of REFRESH is an important first step to establishing future implementation and efficacy.
癌症相关疲劳（CRF）是癌症治疗中常见且往往使人衰弱的副作用，在治疗结束后可能持续数年。认知行为疗法（CBT）对CRF的益处已得到充分证实；然而，这些干预措施通常不包括在标准临床护理中。传统的CBT资源密集，限制了在医院环境中的实施。阶梯式护理方法可以让更多人受益，使用与传统模式相同的人员。
方法/设计：这是一项单臂可行性研究。50名患有癌症诊断、治疗后至少12周或正在接受长期维持治疗、患有持续影响日常活动的CRF的患者将参加阶梯式护理CBT项目。
阶梯式护理项目包括两个步骤。步骤1：所有参与者首先开始为期5周的针对疲劳的支持性自我管理CBT项目。步骤2：如果在步骤1后疲劳仍然严重或在疲劳测量上的变化小于最小临床重要差异，参与者将接受四节由治疗师指导的团体CBT。
参与者将在基线、6周和10周时完成问卷调查。主要结果是REFRESH项目的可行性。实施评估包括研究干预措施的可接受性、满意度、适宜性和可行性，以及包括成本、流程、程序和实施情况在内的管理数据。次要结果是疲劳、生活质量和自我效能的变化。
REFRESH项目将是澳大利亚首个针对持续性CRF的阶梯式护理CBT干预措施。评估REFRESH的可行性是确定未来实施和疗效的重要第一步。
