Nottingham University Hospitals NHS Trust, Nottingham, UK
Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.
BMJ Open. 2021 Jun 1;11(6):e051091. doi: 10.1136/bmjopen-2021-051091.
Survivors of childhood brain tumours have the poorest health-related quality of life of all cancer survivors due to the multiple physical and psychological sequelae of brain tumours and their treatment. Remotely delivered acceptance and commitment therapy (ACT) may be a suitable and accessible psychological intervention to support young people who have survived brain tumours. This study aims to assess the feasibility and acceptability of remotely delivered ACT to improve quality of life among these young survivors.
This study is a two-arm, parallel group, randomised controlled trial comparing ACT with waitlist control at 12-week follow-up as the primary endpoint. Seventy-two participants will be recruited, who are aged 11-24 and have completed brain tumour treatment. Participants will be randomised to receive 12 weeks of ACT either immediately or after a 12-week wait. The DNA-v model of ACT will be employed, which is a developmentally appropriate model for young people. Feasibility will be assessed using the proportion of those showing interest who consent to the trial and complete the intervention. Acceptability will be assessed using participant evaluations of the intervention, alongside qualitative interviews and treatment diaries analysed thematically. A range of clinical outcome measures will also assess physical and mental health, everyday functioning, quality of life and service usage at 12-week follow-up. The durability of treatment effects will be assessed by further follow-up assessments at 24 weeks, 36 weeks and 48 weeks.
Ethical approval was given by East Midlands, Nottingham 1 Research Ethics Committee (Reference: 20/EM/0237). Study results will be disseminated in peer-reviewed journals, through public events and relevant third sector organisations.
ISRCTN10903290; NCT04722237.
由于脑肿瘤及其治疗的多种身体和心理后遗症，脑肿瘤幸存者的健康相关生活质量是所有癌症幸存者中最差的。远程提供的接受和承诺疗法（ACT）可能是一种合适且易于获得的心理干预措施，可以为脑肿瘤幸存者提供支持。本研究旨在评估远程提供的 ACT 改善这些年轻幸存者生活质量的可行性和可接受性。
这是一项两臂、平行组、随机对照试验，以 12 周随访时的主要终点比较 ACT 与等待对照。将招募 72 名年龄在 11-24 岁之间且已完成脑肿瘤治疗的参与者。参与者将随机分配接受 12 周的 ACT，要么立即进行，要么在等待 12 周后进行。将采用 DNA-v 模型的 ACT，这是一种适合年轻人的发展适当的模型。可行性将通过表现出对试验感兴趣的参与者中同意参加试验并完成干预的比例来评估。可接受性将通过参与者对干预的评价、定性访谈和主题分析的治疗日记来评估。一系列临床结果测量也将在 12 周随访时评估身心健康、日常功能、生活质量和服务使用情况。通过 24 周、36 周和 48 周的进一步随访评估来评估治疗效果的持久性。
东米德兰兹、诺丁汉 1 研究伦理委员会（参考号：20/EM/0237）已批准伦理。研究结果将在同行评议的期刊、公开活动和相关的第三部门组织中传播。
ISRCTN82003544。
