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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: Dedicated and coordinated monitoring

• Registration Number: NCT04228432
• Lead Sponsor: Institut Claudius Regaud

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-13
• Study First Posted: 2020-01-14
• Study Start: 2020-02-28
• Status Verified: 2021-07
• Primary Completion: 2021-07-21
• Study Completion: 2021-07-21
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with breast cancer treated by adjuvant hormonotherapy	Dedicated and coordinated monitoring	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut Universitaire du Cancer Toulouse Oncopole; 🇫🇷 Toulouse, France