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

Vera Atema, Marieke van Leeuwen, Hester S.A. Oldenburg, Valesca Retèl, Marc van Beurden, Myra S. Hunter, Neil K. Aaronson*

*Corresponding author for this work

    Research output: Contribution to journalArticleAcademicpeer-review

    6 Citations (Scopus)
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    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.

    Original languageEnglish
    Article number920
    JournalBMC cancer
    Volume16
    Issue number1
    DOIs
    Publication statusPublished - 25 Nov 2016

    Fingerprint

    Cognitive Therapy
    Internet
    Survivors
    Randomized Controlled Trials
    Breast Neoplasms
    Menopause
    Cost-Benefit Analysis
    Therapeutics
    Waiting Lists
    Sweat
    Self Care
    Random Allocation
    Sleep
    Quality of Life
    Psychology
    Costs and Cost Analysis
    Control Groups

    Keywords

    • Breast cancer
    • Cognitive behavioral therapy
    • Cost-effectiveness
    • EHealth
    • Hot flushes
    • Internet-based
    • Menopause
    • Randomized controlled trial
    • Self-management

    Cite this

    Atema, Vera ; van Leeuwen, Marieke ; Oldenburg, Hester S.A. ; Retèl, Valesca ; van Beurden, Marc ; Hunter, Myra S. ; Aaronson, Neil K. / Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors. In: BMC cancer. 2016 ; Vol. 16, No. 1.
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    title = "Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors",
    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.",
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    Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors. / Atema, Vera; van Leeuwen, Marieke; Oldenburg, Hester S.A.; Retèl, Valesca; van Beurden, Marc; Hunter, Myra S.; Aaronson, Neil K.

    In: BMC cancer, Vol. 16, No. 1, 920, 25.11.2016.

    Research output: Contribution to journalArticleAcademicpeer-review

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    T1 - Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors

    AU - Atema, Vera

    AU - van Leeuwen, Marieke

    AU - Oldenburg, Hester S.A.

    AU - Retèl, Valesca

    AU - van Beurden, Marc

    AU - Hunter, Myra S.

    AU - Aaronson, Neil K.

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    KW - Menopause

    KW - Randomized controlled trial

    KW - Self-management

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