Cognitive behavioral therapy and physical exercise for climacteric symptoms in breast cancer patients experiencing treatment-induced menopause: design of a multicenter trial.

Full Abstract

BACKGROUND: Premature menopause is a major concern of younger women undergoing adjuvant therapy for breast cancer. Hormone replacement therapy is contraindicated in women with a history of breast cancer. Non-hormonal medications show a range of bothersome side-effects. There is growing evidence that cognitive behavioral therapy (CBT) and physical exercise can have a positive impact on symptoms in naturally occurring menopause. The objective of this study is to investigate the efficacy of these interventions among women with breast cancer experiencing treatment-induced menopause. METHODS/DESIGN: In a randomized, controlled, multicenter trial, we are evaluating the effectiveness of CBT/relaxation, of physical exercise and of these two program elements combined, in reducing menopausal symptoms, improving sexual functioning, reducing emotional distress, and in improving the health-related quality of life of younger breast cancer patients who experience treatment-induced menopause. 325 breast cancer patients (aged < 50) are being recruited from hospitals in the Amsterdam region, and randomly allocated to one of the three treatment groups or a 'waiting list' control group. Self-administered questionnaires are completed by the patients at baseline, and at 12 weeks (T1) and 6 months (T2) post-study entry. Upon completion of the study, women assigned to the control group will be given the choice of undergoing either the CBT or physical exercise program. DISCUSSION: Cognitive behavioral therapy and physical exercise are potentially useful treatments among women with breast cancer undergoing treatment-induced, premature menopause. For these patients, hormonal and non-hormonal therapies are contraindicated or have a range of bothersome side-effects. Hence, research into these interventions is needed, before dissemination and implementation in the current health care system can take place.

Author information

Author/s: Duijts, Saskia F A (SF); Oldenburg, Hester S A (HS); van Beurden, Marc (M); Aaronson, Neil K (NK);

Affiliation: The Netherlands Cancer Institute, Division of Psychosocial Research and Epidemiology, Amsterdam, the Netherlands. s.duijts(-atsign-)nki.nl

Journal and publication information

Publication Type: Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

Journal: BMC women's health (BMC Womens Health), published in England. (Language: eng)

Reference: 2009-; vol 9 (issue ) : pp 15

Dates: Created 2009/07/08; Completed 2009/09/03;

PMID: 19500403, status: MEDLINE (last retrieval date: 9/4/2009, IMS Date: )

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