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临床试验/NCT04775043
NCT04775043已完成不适用

Etude Observationnelle de Cohorte Prospective évaluant Les bouffées de Chaleur Sur Deux Populations de Patientes : Population témoin et Patientes Sous hormonothérapie Adjuvante Pour un Cancer du Sein Hormonosensible

Institut Curie1 个研究点 分布在 1 个国家目标入组 290 人开始时间: 2021年3月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
290
试验地点
1
主要终点
Score at the Hot Flash Related Daily Interference Scale

研究概览

简要总结

The validation of the HFRDIS questionnaire in French will allow the use in common practice of this questionnaire in consultation in order to have a concrete and reproducible assessment of the impact of hot flashes on the daily life of patients. This validation will also allow this questionnaire to be used in therapeutic trials to assess the effectiveness of a symptomatic treatment under study.

The use of this questionnaire in patients on hormone therapy will allow for an overall assessment of the impact of hot flashes in their daily lives.

There are no risks induced by participation in this research, it is only an observational study without change on the monitoring of participants in both cohorts.

详细描述

The main objective is to assess the impact of hot flashes on the daily lives of patients on adjuvant hormone therapy for hormone-sensitive breast cancer.

The primary test of judgment is composite. The first step is a French validation of the HFRDIS questionnaire assessing the impact of hot flashes on daily life in a control population free of breast cancer (validated in English). The second step is a comparison of the impact of hot flashes on the quality of life of patients in both populations (control and hormone therapy adjuvant for hormone-sensitive breast cancer) via the HFRDIS questionnaire.

In the first part of the study (control population): Patients will be seen in a city gynecology consultation. Patients between the ages of 40 and 60 will be offered participation in the study consecutively. If patients answer "yes" to the question "Do you have hot flashes?", they will then be included in the study and will have access to the study questionnaire. Upon their 2nd connection on the website (D15), patients will answer the HFRDIS Questionnaire again.

In the second part of the study (patients on hormone therapy for breast cancer): Patients at the Institut Curie Saint Cloud aged 40 to 60 years included on hormone therapy adjuvant therapy who will be seen in a monitoring consultation will be offered participation in the study consecutively.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Score at the Hot Flash Related Daily Interference Scale

时间窗: Day 1

The score is calculated with 10 questions ticked from 0 to 10. The highest numbers are a higher degree of impact on the participant Life. If the participant are not prone to hot flashes or if hot flashes do not no impact on these aspects of her life, she checks "0" for all categories. The total score of a scale ranges from 0 to 100.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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