Study Evaluating Hot Flashes in Hormone Sensitive Breast Cancer

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04775043
Study type	Observational
Source	Institut Curie
Contact
Status	Completed
Phase
Start date	March 23, 2021
Completion date	April 11, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Study Evaluating Hot Flashes in Hormone Sensitive Breast Cancer — HOTSHOT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms