Laidsaar-Powell Rebekah, Giunta Sarah, Beatty Lisa, Butow Phyllis, Costa Daniel, Lam Aaron, Juraskova Ilona, Cook Olivia, Crawford-Williams Fiona, Rankin Nicole M, Shaw Joanne
Psycho-Oncology Co-operative Research Group, University of Sydney, Sydney, Australia; School of Psychology, University of Sydney, Sydney, Australia.
Psycho-Oncology Co-operative Research Group, University of Sydney, Sydney, Australia; School of Psychology, University of Sydney, Sydney, Australia.
Contemp Clin Trials. 2025 Jan;148:107749. doi: 10.1016/j.cct.2024.107749. Epub 2024 Nov 17.
Family or friend carers of people with cancer report high levels of depression, anxiety, caregiving strain, and unmet needs. Limited strategies for identification and management of distress have been established among cancer carers. This paper describes the protocol of two linked studies: Study 1a, a distress screening and stepped care pathway feasibility study and Study 1b, a hybrid implementation-effectiveness Randomised Controlled Trial (RCT) to assess the benefit of a comprehensive, carer-centred online Cognitive Behavioural Therapy (iCBT) program for carers with anxiety and depression.
For Study 1a, 300 cancer carers will be screened for distress. Carers with low distress will be referred to publicly available carer resources. Carers scoring 4 and higher on the distress thermometer will complete depression and anxiety measures. Carers with high anxiety/depression will be recommended psychological therapy. Carers with mild/moderate anxiety and/or depression will be allocated to the Carers iCBT Program, evaluated via a RCT with waitlist control group (Study 1b). For Study 1b, intervention group carers will receive access to a 6-lesson self-directed online iCBT program. Waitlist-controls will access the intervention at 14 weeks. Intervention and control groups will complete baseline, 6 week, and 14 week self-report measures; controls will complete additional measures at 20 and 28 weeks. A sample size of n = 166 carers in the iCBT RCT is needed.
If acceptable, feasible and effective, this pathway and iCBT intervention could offer a sustainable, scalable and low-cost approach to identifying and managing distress in carers, and potentially improving patient and carer outcomes.
Australian and New Zealand Clinical Trial Registry number: ACTRN12623001341617p.
癌症患者的家庭或朋友照顾者报告称，他们有高度的抑郁、焦虑、照顾压力和未满足的需求。在癌症照顾者中，针对痛苦识别和管理的策略有限。本文描述了两项相关研究的方案：研究1a，一项痛苦筛查和逐步护理途径可行性研究；研究1b，一项混合实施-效果随机对照试验（RCT），以评估一项全面的、以照顾者为中心的在线认知行为疗法（iCBT）项目对患有焦虑和抑郁的照顾者的益处。
对于研究1a，将对300名癌症照顾者进行痛苦筛查。痛苦程度低的照顾者将被转介到公开可用的照顾者资源处。在痛苦温度计上得分4分及以上的照顾者将完成抑郁和焦虑测量。焦虑/抑郁程度高的照顾者将被推荐接受心理治疗。患有轻度/中度焦虑和/或抑郁的照顾者将被分配到照顾者iCBT项目中，通过与等待名单对照组的随机对照试验进行评估（研究1b）。对于研究1b，干预组的照顾者将可以使用一个6节的自主在线iCBT项目。等待名单对照组将在14周时获得该干预。干预组和对照组将完成基线、6周和14周的自我报告测量；对照组将在20周和28周完成额外的测量。iCBT随机对照试验需要166名照顾者作为样本量。
如果该途径和iCBT干预是可接受的、可行的和有效的，那么它可以提供一种可持续的、可扩展的和低成本的方法来识别和管理照顾者的痛苦，并有可能改善患者和照顾者的结局。
澳大利亚和新西兰临床试验注册编号：ACTRN12623001341617p。
