一项关于基于互联网的认知行为疗法对乳腺癌幸存者治疗引起的更年期症状的随机对照试验的设计。
Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors.
作者信息
Atema Vera, van Leeuwen Marieke, Oldenburg Hester S A, Retèl Valesca, van Beurden Marc, Hunter Myra S, Aaronson Neil K
机构信息
Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
Department of Surgical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
出版信息
BMC Cancer. 2016 Nov 25;16(1):920. doi: 10.1186/s12885-016-2946-1.
BACKGROUND
Menopausal symptoms are common and may be particularly severe in younger women who undergo treatment-induced menopause. Medications to reduce menopausal symptoms are either contra-indicated or have bothersome side effects. Previous studies have demonstrated that face-to-face cognitive behavioral therapy (CBT) is effective in alleviating menopausal symptoms in women with breast cancer. However, compliance with face-to-face CBT programs can be problematic. A promising approach is to use the Internet to make this form of CBT more accessible and feasible for patients. This study is evaluating the efficacy and cost-effectiveness of an Internet-based CBT program, with or without therapist guidance, in alleviating or reducing the severity of menopausal symptoms.
METHODS/DESIGN: In a multicenter, randomized controlled trial we are evaluating the efficacy of two Internet-based CBT programs in alleviating or reducing the impact of menopausal symptoms, and particularly hot flushes and night sweats, in breast cancer survivors who have experienced a treatment-induced menopause. Secondary outcomes include sexual functioning, sleep quality, hot flush frequency, psychological distress, health-related quality of life and cost-effectiveness. We will recruit 248 women who will be randomized to either a therapist guided or a self-management version of the 6-week Internet-based CBT program, or to a usual care, waiting list control group. Self-administered questionnaires are completed at baseline (T0), and at 10 weeks (T1) and 24 weeks (T2) post-randomization.
DISCUSSION
Internet-based CBT is a potentially useful treatment for reducing menopausal symptoms in breast cancer survivors. This study will provide evidence on the efficacy and cost-effectiveness of such an Internet-based CBT program, with or without therapist support. If demonstrated to be efficacious and cost-effective, the availability of such structured supportive intervention programs will be a welcome addition to standard medical treatment offered to cancer patients with treatment-induced menopause.
TRIAL REGISTRATION
The study is retrospectively registered at ClinicalTrials.gov on January 26th 2016 ( NCT02672189 ).
背景
更年期症状很常见，在接受治疗导致更年期的年轻女性中可能尤为严重。用于减轻更年期症状的药物要么有禁忌，要么有令人烦恼的副作用。先前的研究表明，面对面的认知行为疗法（CBT）对缓解乳腺癌女性的更年期症状有效。然而，坚持参加面对面的CBT项目可能存在问题。一种有前景的方法是利用互联网，使这种形式的CBT对患者来说更容易获得且可行。本研究正在评估基于互联网的CBT项目（有或没有治疗师指导）在减轻或降低更年期症状严重程度方面的疗效和成本效益。
方法/设计：在一项多中心随机对照试验中，我们正在评估两个基于互联网的CBT项目在减轻或降低经历治疗导致更年期的乳腺癌幸存者更年期症状的影响方面的疗效，特别是潮热和盗汗。次要结果包括性功能、睡眠质量、潮热频率、心理困扰、健康相关生活质量和成本效益。我们将招募248名女性，她们将被随机分配到为期6周的基于互联网的CBT项目的治疗师指导版或自我管理版，或常规护理、等候名单对照组。在基线（T0）以及随机分组后10周（T1）和24周（T2）完成自我管理问卷。
讨论
基于互联网的CBT是减轻乳腺癌幸存者更年期症状的一种潜在有用的治疗方法。本研究将提供关于这种基于互联网的CBT项目（有或没有治疗师支持）的疗效和成本效益的证据。如果被证明是有效且具有成本效益的，那么这种结构化支持干预项目的可用性将是为经历治疗导致更年期的癌症患者提供的标准医疗治疗中一个受欢迎的补充。
试验注册
该研究于2016年1月26日在ClinicalTrials.gov上进行回顾性注册（NCT02672189）。
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