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)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 10
- 主要终点
- Description of the quality-of-life data collected at the time of inclusion using the validated DLQI questionnaire
研究概览
简要总结
The goal of this European observational study (Frane, Spain, italy, Spain and Greece) is to describe the quality of life related to dermatological toxicities, in adult women patients with Early Breast Cancer (EBC), treated with an ongoing adjuvant endocrine monotherapy initiated for 2 to 3 years ago before inclusion in the study.
In order to answer these objectives, the patient are completing 4 quality of life questionnaires focussed on dermatological issues (DLQI, Skindex-16, Hairdex and ItchyQoL) at the time of the inclusion.
Early Breast Cancer (EBC) diagnosis and history, demographics/clinical characteristics, skin care/sun protection care and skin toxicities since start of the adjuvant endocrine therapy will be collected by the investigator in the eCRF.
详细描述
Patients will complete the questionnaires at inclusion using a webbased PRO system
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females aged ≥ 18 years at inclusion.
- •Histologically confirmed diagnosis of EBC, according to the WHO criteria and the TNM classification, at any time before inclusion.
- •Still being treated with adjuvant endocrine monotherapy, initiated 2 years (up to 1 year and 9 months) to 3 years (up to 3 years and 6 months) before the inclusion in the study.
- •Signed Informed Consent Form (ICF) or non-opposition, according to local regulations.
排除标准
- •Patients not able to read, understand and complete Questionnaires in local language.
- •with chronic dermatological conditions (treated or not) before initiating the adjuvant endocrine therapy that could interfere with the quality of life.
- •Patients with concomitant targeted therapies with adjuvant endocrine therapy such as CDK4/6 inhibitors or trastuzumab, and patients with ongoing treatment with neratinib.
- •Patients having relevant or severe comorbidities requiring complex therapeutic treatment.
- •Patients having a persistent post-chemotherapy alopecia (at least of grade 1)
结局指标
主要结局
Description of the quality-of-life data collected at the time of inclusion using the validated DLQI questionnaire
时间窗: At inclusion
The DLQI consists of 10 questions concerning patients' perception of the impact of skin diseases on different aspects of their health-related quality of life over the last week, including symptoms, feelings, daily activities, leisure, work, school, personal relationships, and treatment. The primary endpoint is the rate of patients with a DLQI score ≥ 6. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired: * 0 - 1 corresponds to no effect at all on patient's life, * 2 - 5 corresponds to small effect on patient's life, * 6 - 10 corresponds to moderate effect on patient's life, * 11 - 20 corresponds to very large effect on patient's life, * 21 - 30 corresponds to extremely large effect on patient's life.
次要结局
- Quality of life data collected at the time of inclusion using the Skindex-16, Hairdex, and ItchyQoL questionnaires.(At inclusion)
- Ongoing dermatological toxicities reported by investigator according to Common Terminology Criteria for Adverse Events (CTCAE) (version 5.0, November 2017)(At inclusion)
- Demographics, and clinical characteristics at the time of inclusion, including the following items(At inclusion)