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


CONCLUSIONS
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.
Duijts
Saskia F A
SF
The Netherlands Cancer Institute, Division of Psychosocial Research and Epidemiology, Amsterdam, the Netherlands. s.duijts@nki.nl
Oldenburg
Hester S A
HS
van Beurden
Marc
M
Aaronson
Neil K
NK
D000328:Adult; D000568:Amenorrhea / Q000139:chemically induced* / Q000534:rehabilitation*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001828:Body Image; D001943:Breast Neoplasms / Q000188:drug therapy*; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003863:Depression / Q000139:chemically induced / Q000628:therapy; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D019584:Hot Flashes / Q000139:chemically induced / Q000628:therapy; D006801:Humans; D008594:Menopause, Premature; D008875:Middle Aged; D017060:Patient Satisfaction; D011788:Quality of Life; D012064:Relaxation Therapy / Q000379:methods; D019529:Sexuality; D016896:Treatment Outcome; D014555:Urination Disorders / Q000139:chemically induced / Q000628:therapy
D000970:Antineoplastic Agents