5 Years Follow-up With Adjuvant Therapy for Women With Breast Invasive Carcinoma

Study Overview
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Brief Summary
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Non-persistence to adjuvant hormonal therapy for breast cancer at 5 years decrease its efficacy. The objective of this study is to know the women experience (persistence, treatment changes, quality of life) and its determinants, in a french population.

Official Title
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5 Years Follow-up in the Lorraine Institute of Oncology With Adjuvant Therapy for Women With Breast Invasive Carcinoma

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: questionnary of quality of life


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients following-up in the Lorraine Institute of Oncology at 5 years of the beginning of an adjuvant hormonal therapy Women with breast invasive carcinoma positive-RH and indication of adjuvant hormonal therapy Adult patients Being capable and agree to follow the study procedure Patients informed and non-opposed Covered by social security Exclusion Criteria: History of other cancer except basal cell carcinoma Patients with breast invasive carcinoma negative-RH Synchronous metastases Relapsed Previous adjuvant hormonal therapy Men Patients with guardianship

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational<br>Patients followed for a medical consultation in the Institut de Cancérologie de Lorraine at 5 years of the beginning of an adjuvant hormonal therapy. | Other: questionnary of quality of life<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors associated with persistence to hormone therapy for breast cancer | Women will be classed as persistent if they don't discontinue or abandon hormone therapy during the 5 years after the introduction of the medication. The information will be recorded thanks to a self-questionnary fulfilled the inclusion day. The baseline characteristics will be compared between persistent women and non-persistent women. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the quality of life | Quality of life between patients who continued hormone therapy for 5 years and patients who discontinued treatment early will be searched for using the questionnaire | 1 day | 
| Proportion of women with a change in their treatment | Proportion of women who have changed treatment within 5 years following the placing on hormone therapy and reasons for the change. | 1 day | 
| Cause of treatment discontinuation | In the subgroup of women who stopped hormone therapy within 5 years following the hormone therapy, determination of the treatment discontinuation. | 1 day | 
| Continued homonotherapy | In the subgroup of women who have been treated with hormone therapy for 5 years, determine the proportion of women not opposed to the continuation of hormone therapy beyond 5 years | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hormone replacement therapy, breast cancer, follow up