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

November 3, 2021 updated by: Institut du Cancer de Montpellier - Val d'Aurelle

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

246

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Herault
      • Montpellier, Herault, France, 34298
        • ICM Val D'Aurelle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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. The control group will be composed of patients followed for an in situ carcinoma treated by surgery +/- radiotherapy, without hormone therapy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
target population
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
PFDI-20 / PFIQ-7 questionnaires (one shot)
control population
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
PFDI-20 / PFIQ-7 questionnaires (one shot)

What is the study measuring?

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 +).
Time Frame: Day 1
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 -)
Time Frame: Day 1
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 +
Time Frame: Day 1
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
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))
Day 1
Estimate pelvic symptoms in the hormone therapy (Hormonotherapy +) / Non hormone therapy (Hormonotherapy -) groups
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))
Day 1
Evaluate the correlation between hormone therapy and pelvic static disorders
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)
Day 1
Research the risk factors for pelvic static disorders
Time Frame: Day 1
number of risk factors based on data collected
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Investigators

  • Study Chair: Laure DELMOND, MD, ICM Val D'Aurelle

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 18, 2020

Primary Completion (ACTUAL)

February 12, 2021

Study Completion (ACTUAL)

July 6, 2021

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (ACTUAL)

August 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 4, 2021

Last Update Submitted That Met QC Criteria

November 3, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROICM 2020-01 OST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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