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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02672189
Other study ID # NKI 2014-6788 / NL53182.031.15
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date February 2015
Est. completion date February 2019

Study information

Verified date August 2019
Source The Netherlands Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The current study will evaluate systematically the efficacy and cost-effectiveness of two internet-based CBT/relaxation programs (one guided, the other self-managed) in reducing the severity of menopausal symptoms and improving copings skills with regard to hot flushes and night sweats as well as improving sexual functioning, improving quality of sleep, reducing emotional distress and improving quality of life in younger breast cancer patients who experience treatment-induced menopause.


Description:

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Study Design


Intervention

Behavioral:
EVA-Online
Internet-based cognitive behavioral therapy

Locations

Country Name City State
Netherlands Netherlands Cancer Institute Amsterdam

Sponsors (2)

Lead Sponsor Collaborator
The Netherlands Cancer Institute Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

References & Publications (30)

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Outcome

Type Measure Description Time frame Safety issue
Primary Change in overall levels of menopausal symptoms Overall levels of menopausal symptoms are assessed by using the FACT-ES Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)
Primary Change in vasomotor symptoms Vasomotor symptoms are assessed with the Hot Flush Rating Scale (HFRS) Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)
Secondary Change in overall levels of sexual functioning The overall levels of sexual functioning are assessed with the Sexual Activity Questionnaire (SAQ) Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)
Secondary Change in psychological distress Psychological distress is assessed with the Hospital Anxiety and Depression Scale (HADS) Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)
Secondary Change in sleep quality Sleep quality is assessed with the Groningen Sleep Quality Scale (GSQS) Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)
Secondary Change in hot flush frequency Hot flush frequency is assessed with the frequency subscale of the Hot Flush Rating Scale (HFRS) Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)
Secondary Change in health related quality of life Health related quality of life is assessed with the SF-36 questionnaire Baseline (T0); 10 weeks post baseline (T1) and 6 months post baseline (T2)
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