Metastatic Breast Carcinoma and Women Sexual Quality of Life

NCT ID: NCT03408769

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-12

Study Completion Date

2018-04-04

Brief Summary

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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

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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.

Conditions

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Metastatic Breast Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Medical questionnaire

* Brief Index of Sexual Functioning for Women questionnaire
* Quality of life questionnaire (EORTC QLQ-BR23)
* Partnership questionnaire (partnerschaftsfragebogen; PFB)
* Short interview about their sexual intimacy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut de Cancérologie de Lorraine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dubuc Myriam

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

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Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2017-A03413-50

Identifier Type: -

Identifier Source: org_study_id

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