Background

Depression and anxiety are common problems among breast cancer survivors. Carer support is one of the most important determinants of women's psychological wellbeing. Survivors' distress can be alleviated by giving carers access to survivors' evidence-based treatment, which will help carers understand what survivors have been going through and help survivors feel more supported. Given the limited access to evidence-based treatments, an adapted internet-delivered cognitive behavioural therapy (iCBT) intervention for breast cancer survivors, but also open for carers' access, has the potential to decrease survivors' depression and anxiety symptoms and improve cancer-related communication and relationship quality between survivors and carers.

Objectives

This study evaluates (1) the effectiveness of a guided iCBT intervention for depression and/or anxiety symptoms among breast cancer survivors with and without main carer access, and (2) the acceptability and satisfaction with the iCBT programme.

Method

In this pilot study comparing the effectiveness of an adapted 7-week iCBT without main carer access against the iCBT with main carer access and treatment-as-usual control, 108 breast cancer survivors will be recruited and then randomised to either (1) treatment (n = 72) or (2) treatment-as-usual control group (n = 36) with a 2:1 ratio. The participants in the treatment group will be assigned to either iCBT alone or iCBT with the main carer also having access to the same content based on their preference. The primary outcome measure is the Hospital Anxiety and Depression Scale, and alongside secondary measures such as Cancer-Related Quality of Life, Breast Cancer Worry Scale, Brief COPE, and Medical Outcomes Study Social Support Survey will be completed by the survivors at baseline, post-treatment, and 2-month follow-up. Survivors who have carers will also complete Survivor-Carer Cancer Communication and Relationship Quality measures to provide insights into the effects of carer access. To assess the acceptability and satisfaction with the programme, survivors and their main carers will fill out the Helpful Aspects of Therapy Form (HAT) and Satisfaction with Online Treatment (SAT). Programme effectiveness and the effects of carer access on primary and secondary outcome measures will be evaluated on intention-to-treat and per-protocol basis using Linear-Mixed-Models.

Discussion

This is the first trial comparing the effectiveness and acceptability of iCBT with and without carer access for depression and anxiety among breast cancer survivors. The findings of this study will provide novel data on the acceptability of iCBT programmes for breast cancer survivors and the impact of carer access on them and their carers.

中文翻译：

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一项随机对照试验，比较了互联网提供的认知行为疗法 (iCBT) 与主要护理人员访问与常规治疗对乳腺癌幸存者抑郁和焦虑的影响：研究方案

背景

抑郁和焦虑是乳腺癌幸存者的常见问题。照顾者的支持是女性心理健康最重要的决定因素之一。可以通过让照顾者获得幸存者的循证治疗来减轻幸存者的痛苦，这将有助于照顾者了解幸存者的经历并帮助幸存者感到更多的支持。鉴于获得基于证据的治疗的机会有限，针对乳腺癌幸存者的适应性互联网提供的认知行为疗法 (iCBT) 干预，但也对护理人员开放，有可能减少幸存者的抑郁和焦虑症状并改善癌症-幸存者和照顾者之间的相关沟通和关系质量。

目标

本研究评估 (1) 引导式 iCBT 干预对有和没有主要照顾者的乳腺癌幸存者的抑郁和/或焦虑症状的有效性，以及 (2) 对 iCBT 计划的可接受性和满意度。

方法

在这项试点研究中，比较了经过调整的 7 周 iCBT（没有主要照顾者访问）与 iCBT 与主要照顾者访问和常规治疗控制的有​​效性，将招募 108 名乳腺癌幸存者，然后随机接受（1）治疗（n  = 72) 或 (2) 照常治疗对照组 ( n = 36)，比例为 2:1。治疗组的参与者将被分配到单独的 iCBT 或 iCBT，主要护理人员也可以根据他们的偏好访问相同的内容。主要结果测量是医院焦虑和抑郁量表，以及癌症相关生活质量、乳腺癌担忧量表、简要 COPE 和医疗结果研究社会支持调查等次要测量将由幸存者在基线、术后完成-治疗和2个月的随访。有照顾者的幸存者还将完成幸存者-照顾者癌症沟通和关系质量措施，以深入了解照顾者访问的影响。评估项目的可接受性和满意度，幸存者及其主要照顾者将填写治疗表 (HAT) 和在线治疗满意度 (SAT) 的有用方面。将使用线性混合模型在意向治疗和每个方案的基础上评估计划有效性和护理人员访问对主要和次要结果测量的影响。

讨论

这是第一项比较 iCBT 的有效性和可接受性的试验，无论是否有看护者访问乳腺癌幸存者的抑郁和焦虑。这项研究的结果将提供关于 iCBT 计划对乳腺癌幸存者的可接受性以及护理人员访问对他们及其护理人员的影响的新数据。