Cognitive behavioral therapy (CBT) and physical exercise (PE) for climacteric symptoms in breast cancer patients experiencing treatment-induced menopause: a multicenter randomized trial (EVA project).

Recruiting

Conditions: 1. Menopausal symptoms
 2. vasomotor symptoms
 3. urinary symptoms
 4. quality of life
 5. sexuality
 6. body- and self image
 7. psychological distress. (NLD: menopauzale symptomen, vasomotorische symptomen, urinaire symptomen, kwaliteit van leven, seksualiteit, lichaams- en zelfbeeld, psychische klachten).

Registration Number: NL-OMON23475

Lead Sponsor: KWF Kanker Bestrijding(Dutch Cancer Society)Postbus 755081070 AM Amsterdam020-5700500info@kwfkankerbestrijding.nl

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 325

Inclusion Criteria

Women can be included if they are younger than 50 years of age, with histologically confirmed primary breast cancer (stages: T1 ¨C T4, N0 ¨C 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.

Exclusion Criteria

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 ¡Ý 30 will be excluded from the study. Patients participating in concurrent studies or rehabilitation programs containing psychosocial interventions will also be excluded.