Evaluation of the Prevalence of Pelvic Static Disorders in Women Treated for Localized Breast Cancer During Adjuvant Hormone Therapy.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 246
- Locations
- 1
- Primary Endpoint
- Evaluate the prevalence of pelvic static disorders in patients treated for localized breast cancer and undergoing adjuvant hormone therapy (Hormontherapy +).
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Evaluate the prevalence of pelvic static disorders in patients treated for localized breast cancer and undergoing adjuvant hormone therapy (Hormontherapy +).
Time Frame: Day 1
Pelvic static disorders rate according to the Questionnaire on pelvic static disorders PFDI-20 in patients (hormonotherapy +)
Secondary Outcomes
- Evaluate the correlation between hormone therapy and pelvic static disorders(Day 1)
- Research the risk factors for pelvic static disorders(Day 1)
- Evaluate the prevalence of pelvic static disorders in patients (hormonotherapy -)(Day 1)
- Compare the prevalence of Pelvic static disorders between the 2 groups Hormonotherapy - /Hormonotherapy +(Day 1)
- Estimate pelvic symptoms in the hormone therapy (Hormonotherapy +) / Non hormone therapy (Hormonotherapy -) groups(Day 1)
- Evaluate the impact of pelvic static disorders on quality of life(Day 1)