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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Dedicated and coordinated monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with breast cancer treated by adjuvant hormonotherapy<br> | Other: Dedicated and coordinated monitoring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who do not fail the E-Monitoring protocol |  | 6 months per patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Hormonotherapy, E-monitoring