E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer: Pilot Study

Institut Claudius Regaud1 site in 1 country45 target enrollmentFebruary 28, 2020

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Institut Claudius Regaud
Enrollment: 45
Locations: 1
Primary Endpoint: Rate of patients who do not fail the E-Monitoring protocol
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 28, 2020

End Date

July 21, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Institut Claudius Regaud

Responsible Party

Sponsor

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.

Outcomes

Primary Outcomes

Rate of patients who do not fail the E-Monitoring protocol

Time Frame: 6 months per patient

Secondary Outcomes

Number of medical consultations required over 6 months(6 months per patient)
Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire(6 months per patient)