E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer.
NCT ID: NCT04228432
Last Updated: 2021-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2020-02-28
2021-07-21
Brief Summary
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45 patients will be included.
Patients will be followed during 6 months.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Patients with breast cancer treated by adjuvant hormonotherapy
Dedicated and coordinated monitoring
* Coordinated monitoring performed by a dedicated nurse: consultation before hormonotherapy initiation
* Monitoring at home over a period of 6 months using an e-monitoring tool: assessment of adverse events and completion of GIRERD questionnaire at week 3 and week 6.
Interventions
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Dedicated and coordinated monitoring
* Coordinated monitoring performed by a dedicated nurse: consultation before hormonotherapy initiation
* Monitoring at home over a period of 6 months using an e-monitoring tool: assessment of adverse events and completion of GIRERD questionnaire at week 3 and week 6.
Eligibility Criteria
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Inclusion Criteria
2. Patient equipped with a computer or tablet computer and an internet connection at home
3. Age \> 18 years old
4. Patient affiliated to the french social security system
5. Patient who has signed informed consent before inclusion in the study and before any specific procedures for the study
6. Women of childbearing age should have effective contraception under hormonotherapy
Exclusion Criteria
2. Patient with metastatic breast cancer
3. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
4. Patient previously treated for breast cancer (infiltrating or in-situ) with adjuvant HT or not
5. Patient protected by law.
18 Years
FEMALE
No
Sponsors
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Institut Claudius Regaud
OTHER
Responsible Party
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Locations
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Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, , France
Countries
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Other Identifiers
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19 SEIN 14
Identifier Type: -
Identifier Source: org_study_id
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