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

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).

A meta‐analysis of the efficacy of cognitive behavior therapy on quality of life and psychological health of breast cancer survivors and patients

“…Our findings showed that CBT is an effective treatment for QOL and psychological health of breast cancer survivors and patients. Recently, other delivery formats (eg, telephone‐delivered and internet‐based) have been shown to be equally effective and have the potential to significantly increase access to CBT . But this conclusion requires further research before such treatments can be applied to have comparable long‐term reliability and availability.…”

“…Recently, other delivery formats (eg, telephone-delivered and internet-based) have been shown to be equally effective and have the potential to significantly increase access to CBT. 33 But this conclusion requires further research before such treatments can be applied to have comparable long-term reliability and availability. Cognitive behavior therapy showed more effect in depression of breast cancer patients in America than in other countries.…”

The Effectiveness of Cognitive Behavioral Therapy on Marital Intimacy and Identification of the Basic Psychological Needs Among Couples Referring to Counseling Centers

“…The results show that cognitive-behavioral training has been effective in marital intimacy and identifying basic psychological needs among couples. These results are in line with the findings of Mohaddassi et al [19], Karimi and Khalatbari [21], Bagheri and Samsam Shariat [22], Ehsan Nejad et al [25], Pourmusa et al [27], and Hummel et al [18].…”

“…Also, previous results show that cognitive-behavioral therapy had a significant impact on the intimacy and marital satisfaction of betrayed women [19] and has a significant effect on increasing marital satisfaction, especially in improving communication and marital conflict, marital burnout resolution skills of couples, and their sexual relationships [23,24]. Also, this approach is effective in enhancing marital satisfaction and sexual satisfaction in postmenopausal women [25] and is effective in improving women's quality of life and happiness [26,27].…”

European Menopause and Andropause Society (EMAS) and International Gynecologic Cancer Society (IGCS) position statement on managing the menopause after gynecological cancer: focus on menopausal symptoms and osteoporosis

“…Clinicians should be aware of potential drug interactions with anticancer and adjuvant therapies (eg, see refs 21 22). Cognitive behavioral therapy may also improve menopause symptoms 23. For problems related to vulvovaginal atrophy, a variety of lubricants and bioadhesive moisturizers are available.…”