title: Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  The study is retrospectively registered at ClinicalTrials.gov on January 26th 2016 ( NCT02672189 ).
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
authors.forename: Vera
authors.initials: V
authors.lastname: Atema
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
authors.forename: Marieke
authors.initials: M
authors.lastname: van Leeuwen
authors.affiliation: Department of Surgical Oncology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
authors.forename: Hester S A
authors.initials: HS
authors.lastname: Oldenburg
authors.affiliation: 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.
authors.forename: Valesca
authors.initials: V
authors.lastname: Retèl
authors.affiliation: Department of Gynecology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.
authors.forename: Marc
authors.initials: M
authors.lastname: van Beurden
authors.affiliation: Department of Psychology (at Guy's), Institute of Psychiatry, Kings College London, 5th floor Bermondsey Wing, Guy's Campus, SE1 9RT, London, UK.
authors.forename: Myra S
authors.initials: MS
authors.lastname: Hunter
authors.affiliation: Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. n.aaronson@nki.nl.
authors.forename: Neil K
authors.initials: NK
authors.lastname: Aaronson
mesh_terms: D000328:Adult; D001943:Breast Neoplasms / Q000150:complications / Q000523:psychology*; D015928:Cognitive Behavioral Therapy / Q000191:economics / Q000379:methods*; D003362:Cost-Benefit Analysis; D005260:Female; D006306:Health Surveys; D019584:Hot Flashes / Q000523:psychology / Q000628:therapy*; D006801:Humans; D020407:Internet; D008593:Menopause; D008875:Middle Aged; D011788:Quality of Life / Q000523:psychology; D012107:Research Design; D012189:Retrospective Studies; D012648:Self Care / Q000523:psychology; D012725:Sexual Behavior / Q000523:psychology; D017741:Survivors / Q000523:psychology*; D013546:Sweating; D016896:Treatment Outcome
keywords: Breast cancer; Cognitive behavioral therapy; Cost-effectiveness; Hot flushes; Internet-based; Menopause; Randomized controlled trial; Self-management; eHealth