Abstract
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).
Highlights
Menopausal symptoms are common and may be severe in younger women who undergo treatment-induced menopause
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
We identify potentially eligible patients through hospital registries and the database of the Netherlands Cancer Registry
Summary
A relatively large percentage of young breast cancer survivors experience treatment-induced menopausal symptoms, with hot flushes being the most common and severe symptom [9, 11,12,13,14]. In the current trial we are evaluating the efficacy and cost-effectiveness of Internet-based CBT in alleviating or reducing menopausal symptoms and HF/NS problem ratings in younger breast cancer survivors who experience treatment-induced menopause. Secondary outcomes include sexual functioning, sleep quality HF/NS frequency, psychological distress and overall HRQOL This trial has several notable strengths, including: (1) the randomized trial design; (2) the multicenter nature of the trial; (3) the comparison of both intervention groups with a waiting- list control group; (4) the use of intention-to-treat analysis; (5) the relatively long-term follow-up; and (6) the inclusion of a cost-effectiveness evaluation. Recruitment and follow up proved to be problematic in our previous group CBT trial (EVA-study) [44] We consider it important to first establish the efficacy of the Internet-based CBT program. If demonstrated to be efficacious and cost-effective, the availability of such a structured supportive intervention program will be a welcome addition to standard medical treatment offered to breast cancer survivors.
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