E-monitoring of Patients Under Adjuvant Hormonotherapy for Breast Cancer. (EPOPEE)

Institut Claudius Regaud

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Dedicated and coordinated monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04228432

19 SEIN 14

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient treated for hormone-dependent localized breast cancer with adjuvant HT (tamoxifen or anti-aromatase +/- LHRH agonist)
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

1. Patient with breast cancer who does not require adjuvant hormonotherapy
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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Patients with breast cancer treated by adjuvant hormonotherapy

Experimental group

Treatment:

Other: Dedicated and coordinated monitoring