Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors

BMC Cancer

Study Protocol

Marc van Beurden¹  Myra S. Hunter²  Hester S. A. Oldenburg³  Marieke van Leeuwen⁴  Neil K. Aaronson⁴  Vera Atema⁴  Valesca Retèl⁵ 

[1] Department of Gynecology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands;Department of Psychology (at Guy’s), Institute of Psychiatry, Kings College London, 5th floor Bermondsey Wing, Guy’s Campus, SE1 9RT, London, UK;Department of Surgical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands;Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands;Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands;Department of HTSR, School of Governance and Management, University of Twente, PO Box 217, 7500 AE, Enschede, The Netherlands;

关键词: Breast cancer;    Menopause;    Hot flushes;    Cognitive behavioral therapy;    Internet-based;    Self-management;    eHealth;    Randomized controlled trial;    Cost-effectiveness;   

DOI  :  10.1186/s12885-016-2946-1

 received in 2016-07-01, accepted in 2016-11-10,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundMenopausal 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/designIn 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.DiscussionInternet-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 registrationThe study is retrospectively registered at ClinicalTrials.gov on January 26th 2016 (NCT02672189).

【 授权许可】

CC BY   
© The Author(s). 2016