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Trial record 2 of 4 for:    hotshot
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Study Evaluating Hot Flashes in Hormone Sensitive Breast Cancer (HOTSHOT)

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ClinicalTrials.gov Identifier: NCT04775043
Recruitment Status : Completed
First Posted : March 1, 2021
Last Update Posted : August 29, 2022
Sponsor:
Information provided by (Responsible Party):
Institut Curie

Study Description
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Brief 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.


Condition or disease Intervention/treatment
Breast Cancer Diagnostic Test: HFRDIS questionnaire completion

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
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Study Type : Observational
Actual Enrollment : 290 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : March 23, 2021
Actual Primary Completion Date : April 11, 2022
Actual Study Completion Date : April 11, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Control population
First part of the study for the HFRDIS Questionnaire French validation
 Diagnostic Test: HFRDIS questionnaire completion
HFRDIS Questionnaire (Hot Flash Related Daily Interference Scale) 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
 Diagnostic Test: HFRDIS questionnaire completion
HFRDIS Questionnaire (Hot Flash Related Daily Interference Scale) completion


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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:
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775043


Locations
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France
Institut Curie
Saint-Cloud, France, 92110
Sponsors and Collaborators
Institut Curie
Investigators
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Principal Investigator: Delphine HEQUET, Dr Institut Curie Saint-Cloud
More Information
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT04775043    
Other Study ID Numbers: IC 2020-15
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: August 29, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases