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

Breast Cancer Clinical Trial

— EPOPEE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228432
• Other study ID #: 19 SEIN 14
• Status: Completed
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: July 21, 2021

Study information

• Verified date: July 2021
• Source: Institut Claudius Regaud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 21, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Dedicated 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.

Locations

Country	Name	City	State
France	Institut Universitaire du Cancer Toulouse Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients who do not fail the E-Monitoring protocol		6 months per patient
Secondary	Number of medical consultations required over 6 months		6 months per patient
Secondary	Rate of hormonotherapy adherence evaluated by the GIRERD questionnaire		6 months per patient