Efficacy of internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors: Results of a randomized controlled trial

PURPOSE We evaluated the effect of Internet-based cognitive behavioral therapy (iCBT), with or without therapist support, on the perceived impact of hot flushes and night sweats (HF/NS) and overall levels of menopausal symptoms (primary outcomes), sleep quality, HF/NS frequency, sexual functioning, psychological distress, and health-related quality of life in breast cancer survivors with treatment-induced menopausal symptoms. PATIENTS AND METHODS We randomly assigned 254 breast cancer survivors to a therapist-guided or a selfmanaged iCBT group or to a waiting list control group. The 6-week iCBT program included psycho-education, behavior monitoring, and cognitive restructuring. Questionnaires were administered at baseline and at 10 weeks and 24 weeks postrandomization. We used mixed-effects models to compare the intervention groups with the control group over time. Significance was set at P <.01. An effect size (ES) of .20 was considered small, .50 moderate and clinically significant, and .80 large. RESULTS Compared with the control group, the guided and self-managed iCBT groups reported a significant decrease in the perceived impact of HF/NS (ES, .63 and .56, respectively; both P <.001) and improvement in sleep quality (ES, .57 and .41; both P <001). The guided group also reported significant improvement in overall levels of menopausal symptoms (ES, .33; P = .003), and NS frequency (ES, .64; P