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Clinical Trials/NCT03408769
NCT03408769
Completed
Not Applicable

Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life

Institut de Cancérologie de Lorraine1 site in 1 country30 target enrollmentMarch 12, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metastatic Breast Carcinoma
Sponsor
Institut de Cancérologie de Lorraine
Enrollment
30
Locations
1
Primary Endpoint
Quality of sexual life of postmenopausal women with metastatic breast carcinoma living in couples
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Sexual health is one of the relevant parameters for assesing the quality of life.

Improvement sexual and emotional function improves quality of life scores and depression or anxiety in curative phase.

The purpose of the study is to assess the quality of sexual life of postmenopausal women with metastatic breast cancer in couples and to establish links with overall quality of life and the quality of the relationship.

Detailed Description

We use a quantitative methodology to assess quality of female sexual life, quality of life and quality o relationship with validated scientific questionnaires. The sexual and emotional intimacy will be explored by semi structured interview, not mandatory for patients.

Registry
clinicaltrials.gov
Start Date
March 12, 2018
End Date
April 4, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Institut de Cancérologie de Lorraine
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Women with metastatic breast cancer
  • Age ≥ 50 and \< 70 years old
  • Diagnosis of metastatic breast cancer at least 6 months prior to study participation
  • Patient living with a partner
  • Menopausal women (absence of menstruation for 1 year minimum)
  • ECOG performance status ≤ 2
  • Affiliated to public health system
  • Informed and having expressed her non-opposition

Exclusion Criteria

  • Patient in exclusive palliative care
  • Single or not living in a couple
  • Non-menopausal patient

Outcomes

Primary Outcomes

Quality of sexual life of postmenopausal women with metastatic breast carcinoma living in couples

Time Frame: 1 day

Quality of sexual life will assessed by BISF-W (Brief index of sexual functioning for women) questionnaire

Secondary Outcomes

  • Quality of Relationship of the couple(1 day)
  • Sexual and emotional intimacy(1 day)
  • Quality of life(1 day)

Study Sites (1)

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