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Clinical Trials/NCT03946579
NCT03946579
Completed
Not Applicable

Evaluation of the Quality of Life and Sexuality of Patients Over 65 Years of Age Undergoing Adjuvant Treatment for Breast Cancer

Centre Henri Becquerel3 sites in 1 country14 target enrollmentOctober 16, 2018
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Centre Henri Becquerel
Enrollment
14
Locations
3
Primary Endpoint
Assessment of Sexual Health
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to assess the quality of life and sexuality during adjuvant chemotherapy in over 65 years old patients with breast cancer

Detailed Description

Evaluation of quality of life and sexual health will be assessed by the mean of validated self questionnaires after surgery for breast cancer, before and after adjuvant chemotherapy and one year after initial surgery

Registry
clinicaltrials.gov
Start Date
October 16, 2018
End Date
January 14, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women over 65 years of age
  • treatment by adjuvant therapy for breast cancer
  • sexually active at least three months before inclusion
  • in couple or not

Exclusion Criteria

  • Inflammatory breast cancer
  • Not sexually active before breast cancer diagnosis
  • Opposition to fill sel questionnaire and collection of the data

Outcomes

Primary Outcomes

Assessment of Sexual Health

Time Frame: one year

assessment with Female sexual functionnal index (FSFI) self questionnaire

Secondary Outcomes

  • Assessment of Depression(one year)
  • Assessment of Anxiety(one year)
  • Assessment of Body Image(one year)
  • Assessment ofTiredness(one year)
  • Assessment of Quality of life(one year)

Study Sites (3)

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