- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04228432
E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer. (EPOPEE)
July 26, 2021 updated by: Institut Claudius Regaud
E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer: Pilot Study
This is a monocentric, prospective cohort study evaluating the feasibility of an E-monitoring protocol in patients with breast cancer treated by adjuvant hormonotherapy .
45 patients will be included.
Patients will be followed during 6 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Toulouse, France
- Institut Universitaire du Cancer Toulouse Oncopole
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patient treated for hormone-dependent localized breast cancer with adjuvant HT (tamoxifen or anti-aromatase +/- LHRH agonist)
- Patient equipped with a computer or tablet computer and an internet connection at home
- Age > 18 years old
- Patient affiliated to the french social security system
- Patient who has signed informed consent before inclusion in the study and before any specific procedures for the study
- Women of childbearing age should have effective contraception under hormonotherapy
Exclusion Criteria:
- Patient with breast cancer who does not require adjuvant hormonotherapy
- Patient with metastatic breast cancer
- 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
- Patient previously treated for breast cancer (infiltrating or in-situ) with adjuvant HT or not
- Patient protected by law.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with breast cancer treated by adjuvant hormonotherapy
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of patients who do not fail the E-Monitoring protocol
Time Frame: 6 months per patient
|
6 months per patient
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of medical consultations required over 6 months
Time Frame: 6 months per patient
|
6 months per patient
|
Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire
Time Frame: 6 months per patient
|
6 months per patient
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 28, 2020
Primary Completion (Actual)
July 21, 2021
Study Completion (Actual)
July 21, 2021
Study Registration Dates
First Submitted
January 10, 2020
First Submitted That Met QC Criteria
January 13, 2020
First Posted (Actual)
January 14, 2020
Study Record Updates
Last Update Posted (Actual)
July 27, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19 SEIN 14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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