Impact of dermatological toxicities on quality of life in patients with early breast cancer exposed to adjuvant endocrine therapy: a real-world cross-sectional study - BCARE (Breast Cancer Adjuvant Real-world Evaluation of Dermatological adverse events)
Impact of dermatological toxicities on quality of life in patients with early breast cancer exposed to adjuvant endocrine therapy: a real-world cross-sectional study - BCARE (Breast Cancer Adjuvant Real-world Evaluation of Dermatological adverse events)
Impact of dermatological toxicities on quality of life in patients with early breast cancer exposed to adjuvant endocrine therapy: a real-world cross-sectional study - BCARE (Breast Cancer Adjuvant Real-world Evaluation of Dermatological adverse events)
How is the study conducted?
This study is conducted in Europe (France, Greece, Italy, Spain).
To describe dermatological toxicities, people should complete the day of their inclusion at maximum 4 questionnaires: one on quality of life, one on hair, and two on skin.
This study is a real-life study. Therefore, this study is done in people followed by their physician according to the local clinical practice.
There is no follow-up planned, nor safety data collected.
Who can take part in the trial ?
The following people could participate in the study:
- Women aged ≥ 18 years
- With early breast cancer
- Still being treated with adjuvant endocrine monotherapy, initiated from 2 to 3 years before the inclusion in the study.
- Who consented to participate in the study
What are the objectives of the trial and how are they evaluated ?
The primary objective is to describe the quality of life related to dermatological toxicities. This will be evaluated using a Dermatology Life Quality Index (DLQI) questionnaire. The questionnaire will be completed by people who participate in the study.
The secondary objectives are to describe:
- The dermatological quality using questionnaires for skin and hair
- To dermatological toxicities present at entry in the study
- The demographics and clinical characteristics.
What is the study Medication ?
There is no specific treatment linked to the study. The study has started after people had initiated their anti-cancer treatment. This anti-cancer treatment had been prescribed by their physician. This treatment was in accordance with the planned care.
More information
This study is conducted according to ethical considerations and followed the rules for conducting such study in each participating country. The study did not start before it was approved as per local regulation. People provided their consent to participate in.