PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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.
BACKGROUND: 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.
BACKGROUND: NCT05885984.
METHODS: 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.
BACKGROUND: 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.
BACKGROUND: NCT05885984.
摘要：
背景：癌症相关性疲劳在晚期肺癌患者中很常见。它不仅干扰患者与健康相关的生活质量，但也增加了照顾者的照顾负担。接受和承诺疗法正在成为一种新颖的方式，倡导接受负面经验并根据自己的价值观采取有效行动，以帮助患者在癌症疾病过程中采取有意义的行动。该试验旨在测试可行性，接受和承诺治疗对晚期肺癌患者疲劳干扰的可接受性和初步效果以及照顾者负担。
方法：双臂，将进行评估者盲试随机对照试验。共有40名晚期肺癌患者-护理人员二分体，他们生活在农村地区，将从中国中部的一所大学附属医院招募。参与者将被随机分配以接受在线六期接受和承诺疗法（即涉及隐喻，虚拟现实技术促进的体验式练习和正念练习)加上健康教育(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。主要结果是研究可行性(即合格率，招聘率，流失率和遵守率)，疲劳干扰和照顾者负担。次要结果是健康相关的生活质量，生活的意义，心理灵活性和专注的注意力。将进行半结构化访谈，以在干预组10名参与者的子样本中探索干预的可行性和经验。
背景：本研究已获得香港中文大学-新界东联营临床研究伦理委员会的批准（CRECRef.不。2023.030)和中南大学湘雅医院医学伦理委员会(编号202305336）。调查结果将在同行评审的期刊上以及通过当地或国际会议演讲进行传播。
背景：NCT05885984。
方法：双臂，将进行评估者盲试随机对照试验。共有40名晚期肺癌患者-护理人员二分体，他们生活在农村地区，将从中国中部的一所大学附属医院招募。参与者将被随机分配以接受在线六期接受和承诺疗法（即涉及隐喻，虚拟现实技术促进的体验式练习和正念练习)加上健康教育(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。主要结果是研究可行性(即合格率，招聘率，流失率和遵守率)，疲劳干扰和照顾者负担。次要结果是健康相关的生活质量，生活的意义，心理灵活性和专注的注意力。将进行半结构化访谈，以在干预组10名参与者的子样本中探索干预的可行性和经验。
背景：本研究已获得香港中文大学-新界东联营临床研究伦理委员会的批准（CRECRef.不。2023.030)和中南大学湘雅医院医学伦理委员会(编号202305336）。调查结果将在同行评审的期刊上以及通过当地或国际会议演讲进行传播。
背景：NCT05885984。
