The Nethersole School of Nursing, The Chinese University of Hong Kong Faculty of Medicine, Hong Kong, China.
The Nethersole School of Nursing, The Chinese University of Hong Kong Faculty of Medicine, Hong Kong, China
BMJ Open. 2024 Jul 23;14(7):e082090. doi: 10.1136/bmjopen-2023-082090.
Cancer-related fatigue is common in patients with advanced lung cancer. It not only interferes with patients' health-related quality of life, but also increases the caregiving burden of their caregivers. Acceptance and commitment therapy is emerging as a novel way to advocate accepting negative experiences and taking effective actions based on their own values to help patients commit meaningful actions in the course of cancer diseases. This trial aims to test the feasibility, acceptability and preliminary effects of acceptance and commitment therapy for fatigue interference in patients with advanced lung cancer and the caregiver burden.
A two-arm, assessor-blind pilot randomised controlled trial will be conducted. A total of 40 advanced lung cancer patient-caregiver dyads, who live in rural areas, will be recruited from a university-affiliated hospital in central China. The participants will be randomised to receive an online six-session acceptance and commitment therapy (i.e. involving metaphors, experiential exercises and mindfulness exercises facilitated by virtual reality technology) plus health education (intervention group, n=20) or health education (control group, n=20). Outcomes will be measured at baseline and 1 week postintervention. The primary outcomes are study feasibility (i.e. eligibility rate, recruitment rate, attrition rate and adherence rate), fatigue interference and caregiver burden. The secondary outcomes are health-related quality of life, meaning in life, psychological flexibility and mindful attention. Semistructured interviews will be conducted to explore the feasibility and experiences of the intervention in a subsample of 10 participants from the intervention group.
This study has been approved by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (CREC Ref. No. 2023.030) and the Medical Ethics Committee of Xiangya Hospital Central South University (No. 202305336). The findings will be disseminated in peer-reviewed journals and through local or international conference presentations.
NCT05885984.
癌症相关疲劳在晚期肺癌患者中很常见。它不仅会干扰患者的健康相关生活质量，还会增加照顾者的负担。接受和承诺疗法作为一种新的方法正在出现，它倡导接受负面体验，并基于自己的价值观采取有效行动，帮助患者在癌症病程中采取有意义的行动。本试验旨在测试接受和承诺疗法对晚期肺癌患者及其照顾者疲劳干扰和照顾者负担的可行性、可接受性和初步效果。
这是一项两臂、评估者盲法的先导随机对照试验。总共将从中国中部一所大学附属医院招募 40 对居住在农村地区的晚期肺癌患者-照顾者。参与者将被随机分配接受在线六节接受和承诺疗法（即通过虚拟现实技术提供隐喻、体验式练习和正念练习）加健康教育（干预组，n=20）或健康教育（对照组，n=20）。结果将在基线和干预后 1 周进行测量。主要结果是研究的可行性（即合格率、招募率、失访率和依从率）、疲劳干扰和照顾者负担。次要结果是健康相关生活质量、生活意义、心理灵活性和正念注意力。将对干预组的 10 名参与者进行半结构式访谈，以探索干预的可行性和经验。
本研究已获得香港中文大学-新界东联合临床研究伦理委员会（CREC 注册号 2023.030）和中南大学湘雅医院医学伦理委员会（编号 202305336）的批准。研究结果将在同行评议期刊上发表，并通过当地或国际会议报告。
NCT05885984。
