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 Retel, Marc van Beurden, Myra S. Hunter, Neil K. Aaronson*

*Corresponding author for this work

Research output: Contribution to journalArticleScientificpeer-review

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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) postrandomization.

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
DOIs
Publication statusPublished - 25 Nov 2016

Keywords

  • Breast cancer
  • Menopause
  • Hot flushes
  • Cognitive behavioral therapy
  • Internet-based
  • Self-management
  • eHealth
  • Randomized controlled trial
  • Cost-effectiveness
  • QUALITY-OF-LIFE
  • PLACEBO-CONTROLLED TRIAL
  • SF-36 HEALTH SURVEY
  • HOT FLUSHES
  • NIGHT SWEATS
  • REPLACEMENT THERAPY
  • SALPINGO-OOPHORECTOMY
  • DOUBLE-BLIND
  • SELF-HELP
  • WOMEN

Cite this

Atema, Vera ; van Leeuwen, Marieke ; Oldenburg, Hester S. A. ; Retel, 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.
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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) postrandomization.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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author = "Vera Atema and {van Leeuwen}, Marieke and Oldenburg, {Hester S. A.} and Valesca Retel and {van Beurden}, Marc and Hunter, {Myra S.} and Aaronson, {Neil K.}",
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language = "English",
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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.; Retel, Valesca; van Beurden, Marc; Hunter, Myra S.; Aaronson, Neil K.

In: BMC Cancer, Vol. 16, 920, 25.11.2016.

Research output: Contribution to journalArticleScientificpeer-review

TY - JOUR

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 - Retel, Valesca

AU - van Beurden, Marc

AU - Hunter, Myra S.

AU - Aaronson, Neil K.

PY - 2016/11/25

Y1 - 2016/11/25

N2 - 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) postrandomization.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.

AB - 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) postrandomization.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.

KW - Breast cancer

KW - Menopause

KW - Hot flushes

KW - Cognitive behavioral therapy

KW - Internet-based

KW - Self-management

KW - eHealth

KW - Randomized controlled trial

KW - Cost-effectiveness

KW - QUALITY-OF-LIFE

KW - PLACEBO-CONTROLLED TRIAL

KW - SF-36 HEALTH SURVEY

KW - HOT FLUSHES

KW - NIGHT SWEATS

KW - REPLACEMENT THERAPY

KW - SALPINGO-OOPHORECTOMY

KW - DOUBLE-BLIND

KW - SELF-HELP

KW - WOMEN

U2 - 10.1186/s12885-016-2946-1

DO - 10.1186/s12885-016-2946-1

M3 - Article

VL - 16

JO - BMC Cancer

JF - BMC Cancer

SN - 1471-2407

M1 - 920

ER -