Clinical trial · Observational
Study Evaluating Hot Flashes in Hormone Sensitive Breast Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HFRDIS questionnaire completion | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control population
- description
- First part of the study for the HFRDIS Questionnaire French validation
- interventionNames
- Diagnostic Test: HFRDIS questionnaire completion
- label
- Patients on hormone therapy for breast cancer
- description
- Second par of the study for the HFRDIS questionnaire use on patients on hormone therapy for breast cancer
- interventionNames
- Diagnostic Test: HFRDIS questionnaire completion
Primary outcomes (1)
- measure
- Score at the Hot Flash Related Daily Interference Scale
- timeFrame
- Day 1
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion criteria: * Control population: 1. Patient aged 40 to 60 included. 2. Patient with internet access and email address. 3. Patient affiliated with a social security system, speaking and reading French. 4. Collection of non-opposition to participation in the study. * Hormone therapy for breast cancer 1. Patient aged 40 to 60 included management for RH breast cancer under hormone therapy adjuvant therapy: 2. Patient with internet access and email address. 3. Patient affiliated with a social security system, speaking and reading French. 4. Collection of consent to participate in the study. Exclusion criteria: * Control population: 1. Patient with a personal history of breast cancer. 2. Patient with another cancer in the course of treatment. 3. Woman with a life expectancy \< 6 months at the time of diagnosis (in relation to other serious chronic conditions). 4. Persons deprived of their liberty or under guardianship. 5. Inability to submit to the medical follow-up of the study for social or psychological reasons. * Hormone therapy patients for breast cancer: 1. Patient currently recurrent with breast cancer. 2. Patient in metastatic breast cancer. 3. Woman with a life expectancy \< 6 months at the time of diagnosis (in relation to other serious chronic conditions). 4. Persons deprived of their liberty or under guardianship. 5. Inability to submit to the medical follow-up of the trial for social or psychological reasons.
References
Publications (0)
Data not yet available