Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2016 Nov 25;16(1):920.
doi: 10.1186/s12885-016-2946-1.

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

Vera Atema  1 , Marieke van Leeuwen  1 , Hester S A Oldenburg  2 , Valesca Retèl  1   3 , Marc van Beurden  4 , Myra S Hunter  5 , Neil K Aaronson  6
Affiliations
Randomized Controlled Trial

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

Vera Atema et al. BMC Cancer. .

Abstract

Background: 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.

Methods/design: 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.

Discussion: 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.

Trial registration: The study is retrospectively registered at ClinicalTrials.gov on January 26th 2016 ( NCT02672189 ).

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

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Overview of the overall trial design
See this image and copyright information in PMC

References

    1. GLOBOCAN 2012: Estimated cancer incidence, mortality, and prevalence worldwide in 2012. [http://globocan.iarc.fr/Pages/fact_sheets_population.aspx]
    1. Coleman MP, Forman D, Bryant H, Butler J, Rachet B, Maringe C, Nur U, Tracey E, Coory M, Hatcher J, et al. Cancer survival in Australia, Canada, Denmark, Norway, Sweden, and the UK, 1995–2007 (the International Cancer Benchmarking Partnership): an analysis of population-based cancer registry data. Lancet. 2011;377(9760):127–138. doi: 10.1016/S0140-6736(10)62231-3. - DOI - PMC - PubMed
    1. Society. AC: Cancer Facts Figures - 2000. Atlanta; 2003.
    1. Bines J, Oleske DM, Cobleigh MA. Ovarian function in premenopausal women treated with adjuvant chemotherapy for breast cancer. J Clin Oncol. 1996;14(5):1718–1729. - PubMed
    1. Shapiro CL, Recht A. Side effects of adjuvant treatment of breast cancer. N Engl J Med. 2001;344(26):1997–2008. doi: 10.1056/NEJM200106283442607. - DOI - PubMed

Publication types

MeSH terms

Associated data