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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04228432

Acronym

EPOPEE

Enrollment

Registered

2020-01-14

Start date

2020-02-28

Completion date

2021-07-21

Last updated

2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer, Hormonotherapy, E-monitoring

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.

Interventions

OTHERDedicated 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Rate of patients who do not fail the E-Monitoring protocol	6 months per patient

Secondary

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026