一项针对接受雄激素剥夺治疗的前列腺癌患者管理热潮红和盗汗影响的引导自助认知行为疗法的多中心随机对照试验（MANCAN2）。

A multicentre randomised controlled trial of a guided self-help cognitive behavioural therapy to MANage the impact of hot flushes and night sweats in patients with prostate CANcer undergoing androgen deprivation therapy (MANCAN2).

机构信息

Southampton Clinical Trials Unit, University of Southampton, Southampton, UK.

University Hospital Southampton NHS Foundation Trust, Southampton, UK.

出版信息

Trials. 2023 Jul 10;24(1):450. doi: 10.1186/s13063-023-07325-w.

DOI:10.1186/s13063-023-07325-w

PMID:37430353

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10332063/

Abstract

BACKGROUND

Androgen deprivation therapy (ADT) is prescribed to almost half of all men diagnosed with prostate cancer. Although ADT is effective treatment, with virtually all men with advanced disease showing initial clinical response, it is associated with troublesome side effects including hot flushes and night sweats (HFNS). HFNS can be both frequent and severe and can have a significant impact on quality of life (QoL). They can occasionally be so debilitating that patients stop ADT altogether, despite the increased risk of disease relapse or death. Previous research has found that guided self-help cognitive behavioural therapy (CBT) can be effective in reducing HFNS due to ADT when delivered by a clinical psychologist. MANCAN2 aims test whether we can train the existing NHS Prostate Cancer Nurse Specialist (CNS) team to deliver guided self-help CBT and whether it is effective in reducing the impact of HFNS in men undergoing ADT.

METHODS

MANCAN2 is a phase III multicentre randomised controlled trial and process evaluation. Between 144 and 196 men with prostate cancer who are currently receiving ADT and are experiencing problematic HFNS will be individually randomised in a 1:1 ratio in groups of 6-8 participants to either treatment as usual (TAU) or participation in the guided self-help CBT intervention plus TAU. A process evaluation using the normalisation process theory (NPT) framework will be conducted, to understand the CNS team's experiences of delivering the intervention and to establish the key influencers to its implementation as a routine practice service. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost-effectiveness of the intervention and participant adherence to the trial intervention will also be assessed.

DISCUSSION

MANCAN2 will advance the program of work already conducted in development of management strategies for HFNS. This research will determine whether the severity of ADT-induced HFNS in men with prostate cancer can be reduced by a guided self-help CBT intervention, delivered by the existing NHS prostate cancer CNS team, within a multicentre study. The emphasis on this existing team, if successful, should facilitate translation through to implementation in routine practice.

TRIAL REGISTRATION

ISRCTN reference 58720120 . Registered 13 December 2022.

摘要

背景

雄激素剥夺疗法（ADT）几乎适用于所有被诊断出患有前列腺癌的男性的一半。尽管 ADT 是一种有效的治疗方法，几乎所有晚期疾病的男性最初都表现出临床反应，但它与令人困扰的副作用有关，包括热潮红和盗汗（HFNS）。HFNS 可能既频繁又严重，并对生活质量（QoL）产生重大影响。它们有时会使人衰弱，以至于尽管疾病复发或死亡的风险增加，患者还是会完全停止 ADT。先前的研究发现，当由临床心理学家提供时，引导自助认知行为疗法（CBT）可以有效减少因 ADT 引起的 HFNS。MANCAN2 旨在测试我们是否可以培训现有的 NHS 前列腺癌护士专家（CNS）团队提供引导自助 CBT，以及它是否能有效减少接受 ADT 的男性 HFNS 的影响。

方法

MANCAN2 是一项 III 期多中心随机对照试验和过程评估。144 至 196 名患有前列腺癌且正在接受 ADT 治疗且出现 HFNS 问题的男性将以 6-8 名参与者的小组为单位，以 1:1 的比例进行个体随机分组，分别接受常规治疗（TAU）或接受引导自助 CBT 干预加 TAU。将使用规范化进程理论（NPT）框架进行过程评估，以了解 CNS 团队提供干预措施的经验，并确定其作为常规实践服务实施的关键影响因素。干预措施的实施保真度将通过专家评估进行。还将评估干预措施的成本效益和参与者对试验干预措施的依从性。