Evaluation of the Prevalence of Pelvic Static Disorders in Women With Localized Breast Cancer

Study Overview
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Brief Summary
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In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients

Detailed Description
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Breast cancer is the most common cancer in women. Its incidence increases with 58,459 new cases in France in 2018, however its mortality decreases with a survival rate of 87% at 5 years. Therapeutic options are surgery, radiotherapy, chemotherapy and hormone therapy. Hormone therapy is one of the major treatments for hormone-sensitive tumors with a prescription made in around 70% of breast cancer cases. These different hormone therapies cause a hormonal imbalance with in particular an important anti-estrogenic action. Hormonal deprivation and menopause can be responsible for the occurrence of pelvic statics disorder.[5-9] Pelvic static disorder (PTS) is a common problem for women, which can occur at any age. These disorders include urinary incontinence, stress or urgency, anal incontinence, genital prolapse. Hypothesis's investigator is that hormone therapy may be responsible for PTS. In this study, investigator propose to assess the prevalence of pelvic static disorders in women undergoing adjuvant hormone therapy for localized breast cancer and to assess the overall quality of life in these patients.

Official Title
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Evaluation of the Prevalence of Pelvic Static Disorders in Women Treated for Localized Breast Cancer During Adjuvant Hormone Therapy.

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: PFDI-20 / PFIQ-7 questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with Age ≥ 50 years Menopaused Patient followed for carcinoma in situ or infiltrating the breast with or without hormone therapy Patient who was treated by surgery after June 2015, whether or not followed by radiotherapy or chemotherapy. Patient who agreed, after receiving information, to participate to the study. Exclusion Criteria: Metastatic breast cancer Patient with a history of pelvic static surgery Patient with a history of pelvic irradiation Patient unable or unwilling to complete the questionnaires Patient with a history of urinary incontinence treatment Patient not affiliated to the French social security system Subject under tutelage, curatorship or safeguard of justice, Patient in an emergency situation, Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons, Pregnant and / or breastfeeding woman.

Ages Eligible for Study
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Minimum Age: 50 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 |
| --- | --- |
| target population<br>The target population of the study consists of breast cancer female patients over 50 years old followed for an invasive carcinoma expressing hormone receptors, non metastatic, undergoing adjuvant hormone therapy. | Other: PFDI-20 / PFIQ-7 questionnaires<br>* PFDI-20 / PFIQ-7 questionnaires (one shot)<br>|
| control population<br>The control group will be composed of patients followed for an in situ carcinoma treated by surgery +/- radiotherapy, without hormone therapy. | Other: PFDI-20 / PFIQ-7 questionnaires<br>* PFDI-20 / PFIQ-7 questionnaires (one shot)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the prevalence of pelvic static disorders in patients treated for localized breast cancer and undergoing adjuvant hormone therapy (Hormontherapy +). | Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients (hormonotherapy +) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the prevalence of pelvic static disorders in patients (hormonotherapy -) | Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients hormonotherapy - | Day 1 | 
| Compare the prevalence of Pelvic static disorders between the 2 groups Hormonotherapy - /Hormonotherapy + | Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients hormonotherapy - and patient hormontherapy + | Day 1 | 
| Evaluate the impact of pelvic static disorders on quality of life | Estimation of quality of life according to the PFIQ-7 (Pelvic Floor Impact Questionnaire) in the 2 populations. the total score of the PFIQ-7 is obtained by adding the scores for each scale (between 0 (no impact) and 300 (maximum impact)) | Day 1 | 
| Estimate pelvic symptoms in the hormone therapy (Hormonotherapy +) / Non hormone therapy (Hormonotherapy -) groups | Estimation of pelvic symptoms scores according to the PFDI-20 (Pelvic Floor Distress Inventory) questionnaire in the 2 populations. the total score of the PFDI-20 is obtained by adding the scores for each scale (between 0 (no impact) and 300 (maximum impact)) | Day 1 | 
| Evaluate the correlation between hormone therapy and pelvic static disorders | Estimate the Rational rate between pelvic static disorders and hormone therapy with adjustment on known parameters : age, obesity, type of birth (vaginal or caesarean) | Day 1 | 
| Research the risk factors for pelvic static disorders | number of risk factors based on data collected | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized breast cancer, pelvic static disorders, hormontherapy