A randomized controlled trial of internet-based cognitive behavioral therapy for breast cancer patients with climacteric symptoms.
- Conditions
- OvergangsklachtenClimacteric symptomsmenopausal symptoms
- Registration Number
- NL-OMON42362
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 248
The study sample will be composed of 248 women, younger than 50 years of age at time of breast cancer diagnoses or PBSO, with histologically confirmed primary breast cancer (stages: T1 - T4, N0 - N3 and M0). All women will have been premenopausal at the time of diagnosis, and will have experienced a treatment-induced menopause due to (neo)adjuvant chemotherapy, hormonal therapy or or oophorectomy. Women may currently be receiving adjuvant hormonal therapy. In case of treatment-induced menopause due to adjuvant chemotherapy (with the exception of herceptin), treatment should have been completed a minimum of 4 months and a maximum of 5 years prior to study entry. For women who receive neo-adjuvant chemo, we will use 4 month post-surgery or post-radiation therapy as the minimal time since treatment. Oophorectomy should have been completed no more than 5 years prior to study entry. All women should be disease-free at time of study entry. Potential eligible women will be screened for the presence of menopausal symptoms.
Potentially eligible women will be screened for the presence of problematic hot flushes or night sweats during the past 2 months. Moreover, in the last week they should have experienced at least 10 hot flushes or night sweats during the past week and these hot flushes/night sweats should have been experienced as problematic (as indicated by an average score of two or higher on three items of the HFRS).
Women will be excluded from the study if they lack basic proficiency in Dutch, if they have serious cognitive or psychiatric problems that would preclude them from following the intervention or completing the study questionnaires, or if they have no internet access. Patients participating in concurrent studies or rehabilitation programs to alleviate their menopausal problems will also be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcomes are menopausal complaints, as assessed with a menopausal<br /><br>complaints questionnaire called FACT-ES, and hot flushes and night sweats as<br /><br>assessed by the Hot Flushes Rating Scale (HFRS). </p><br>
- Secondary Outcome Measures
Name Time Method <p> The secondary study outcomes are sexuality problems (SAQ); sleep quality<br /><br>(GSQS); psychological distress (HADS) and health related quality of life (MOS<br /><br>SF- 36). </p><br>