Cognitive Behavioral Therapy (CBT) and Physical Exercise for Climacteric Symptoms in Breast Cancer Patients Experiencing Treatment-Induced Menopause: a Multicenter Randomized Trial
The study sample will be composed of 325 women, younger than 50 years of age, with
histologically confirmed primary breast cancer (stages: T1 - T4, N0 - N1 and M0). All
women will have been premenopausal at the time of diagnosis, have completed adjuvant
chemotherapy (with the exception of herceptin, which can continue to receive) a minimum of
4 months and a maximum of 5 years prior to study entry. Women may currently be receiving
adjuvant hormonal therapy. All women should be disease-free at time of study entry.
Potentially eligible women will be screened for the presence of at least one of the
following 3 menopausal symptoms during the previous 2-month period: hot flushes, sweating
and/or vaginal dryness.
Women will be excluded from the study if they lack basic proficiency in Dutch, if they
have serious cognitive or psychiatric problems, or serious physical comorbidity that would
preclude them from participating in a physical exercise program. Since physical exercise
may be contraindicated as a treatment for hot flushes in obese women, 49 patients with a
BMI ≥ 30 will be excluded from the study. Patients participating in concurrent studies or
rehabilitation programs containing psychosocial interventions will also be excluded.