Cognitive behavioral therapy (CBT) and physical exercise for climacteric symptoms in breast cancer patients experiencing treatment-induced menopause: a multicenter randomized trial.
- Conditions
- climacteric symptomsmenopausal symptoms1000629110074469
- Registration Number
- NL-OMON32151
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 325
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 or hormonal therapy a minimum of 4 months and a maximum of 5 years prior to study entry, and will currently be disease-free. 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, 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Menopausal symptoms<br /><br>- Vasomotor symptoms </p><br>
- Secondary Outcome Measures
Name Time Method <p>- Urinary symptoms<br /><br>- Sexuality<br /><br>- Body image & self-image<br /><br>- Psychological distress<br /><br>- Generic health-related quality of life </p><br>