Back to resultsE-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer. (EPOPEE)
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Dedicated and coordinated monitoring
Sponsored by
About this trial
This is an interventional health services research trial for Breast Cancer focused on measuring Breast Cancer, Hormonotherapy, E-monitoring
Eligibility Criteria
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.
Sites / Locations
- Institut Universitaire du Cancer Toulouse Oncopole
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with breast cancer treated by adjuvant hormonotherapy
Arm Description
Outcomes
Primary Outcome Measures
Rate of patients who do not fail the E-Monitoring protocol
Secondary Outcome Measures
Number of medical consultations required over 6 months
Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire
Full Information
NCT ID
NCT04228432
First Posted
January 10, 2020
Last Updated
July 26, 2021
Sponsor
Institut Claudius Regaud
1. Study Identification
Unique Protocol Identification Number
NCT04228432
Brief Title
E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer.
Acronym
EPOPEE
Official Title
E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Claudius Regaud
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Hormonotherapy, E-monitoring
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with breast cancer treated by adjuvant hormonotherapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Dedicated and coordinated monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of patients who do not fail the E-Monitoring protocol
Time Frame
6 months per patient
Secondary Outcome Measure Information:
Title
Number of medical consultations required over 6 months
Time Frame
6 months per patient
Title
Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire
Time Frame
6 months per patient
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Institut Universitaire du Cancer Toulouse Oncopole
City
Toulouse
Country
France
12. IPD Sharing Statement
Learn more about this trial
E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer.
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