Icm Val D'Aurelle
Montpellier, Herault, 34298, France
NCT Number: NCT04515888
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
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Notify Me50 year and older
Female
Observational
Montpellier, Herault, 34298, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
PFDI-20 / PFIQ-7 questionnaires (one shot)
Time frame: Day 1
Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients (hormonotherapy +)
Time frame: Day 1
Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients hormonotherapy -
Time frame: Day 1
Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients hormonotherapy - and patient hormontherapy +
Time frame: Day 1
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))
Time frame: Day 1
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))
Time frame: Day 1
Estimate the Rational rate between pelvic static disorders and hormone therapy with adjustment on known parameters : age, obesity, type of birth (vaginal or caesarean)
Time frame: Day 1
number of risk factors based on data collected
Institut du Cancer de Montpellier - Val d'Aurelle
Other
Evaluation of the Prevalence of Pelvic Static Disorders in Women Treated for Localized Breast Cancer During Adjuvant Hormone Therapy.
Acronym: STATICBREAST
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