Breast CancerHOTSHOTNCT04775043
Study Evaluating Hot Flashes in Hormone Sensitive Breast Cancer
An observational study of Breast Cancer, run by Institut Curie at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HFRDIS questionnaire completion
- How many people
- 290 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2021to 11 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: * Group for control population: Patient aged 40 to 60 included. * Group for Hormone therapy for breast cancer: Patient aged 40 to 60 included management for RH breast cancer under hormone therapy adjuvant therapy:
Who may be able to join
- Control population:
- Patient aged 40 to 60 included.
- Patient with internet access and email address.
- Patient affiliated with a social security system, speaking and reading French.
- Collection of non-opposition to participation in the study.
- Hormone therapy for breast cancer
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- Patient aged 40 to 60 included management for RH breast cancer under hormone therapy adjuvant therapy:
- Patient with internet access and email address.
- Patient affiliated with a social security system, speaking and reading French.
- Collection of consent to participate in the study.
Who cannot join
- Control population:
- Patient with a personal history of breast cancer.
- Patient with another cancer in the course of treatment.
- Woman with a life expectancy < 6 months at the time of diagnosis (in relation to other serious chronic conditions).
- Persons deprived of their liberty or under guardianship.
- Inability to submit to the medical follow-up of the study for social or psychological reasons.
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- Hormone therapy patients for breast cancer:
- Patient currently recurrent with breast cancer.
- Patient in metastatic breast cancer.
- Woman with a life expectancy < 6 months at the time of diagnosis (in relation to other serious chronic conditions).
- Persons deprived of their liberty or under guardianship.
- Inability to submit to the medical follow-up of the trial for social or psychological reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Breast Cancer
- Being tested
- HFRDIS questionnaire completion
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFRDIS questionnaire completionDiagnostic test
HFRDIS Questionnaire (Hot Flash Related Daily Interference Scale) completion
| Study group | Role | What they receive |
|---|---|---|
| Control population | First part of the study for the HFRDIS Questionnaire French validation Receives: Diagnostic Test: HFRDIS questionnaire completion | |
| Patients on hormone therapy for breast cancer | Second par of the study for the HFRDIS questionnaire use on patients on hormone therapy for breast cancer Receives: Diagnostic Test: HFRDIS questionnaire completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score at the Hot Flash Related Daily Interference Scale
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start23 Mar 2021
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Delphine HEQUET, Dr, Principal investigator, Institut Curie Saint-Cloud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775043
- Sponsor's protocol ID
- IC 2020-15
- Acronym
- HOTSHOT
- Status last verified
- Aug 2022
- First submitted
- 24 Feb 2021
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04775043
- Acronym / sponsor ID
- HOTSHOT / IC 2020-15
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 1 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control population | – | Diagnostic Test: HFRDIS questionnaire completionFirst part of the study for the HFRDIS Questionnaire French validation |
| Patients on hormone therapy for breast cancer | – | Diagnostic Test: HFRDIS questionnaire completionSecond par of the study for the HFRDIS questionnaire use on patients on hormone therapy for breast cancer |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Group for control population: Patient aged 40 to 60 included. * Group for Hormone therapy for breast cancer: Patient aged 40 to 60 included management for RH breast cancer under hormone therapy adjuvant therapy:
Key inclusion criteria (10 listed)
- Control population:
- Hormone therapy for breast cancer
Key exclusion criteria (12 listed)
- Control population:
- Hormone therapy patients for breast cancer:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFRDIS questionnaire completionHFRDIS Questionnaire (Hot Flash Related Daily Interference Scale) completion | Diagnostic test | Control population, Patients on hormone therapy for breast cancer |
Primary outcome
Score at the Hot Flash Related Daily Interference Scale
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Delphine HEQUET, Dr principal investigator
Institut Curie Saint-Cloud
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Institut Curie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score at the Hot Flash Related Daily Interference Scale (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2022.