Metastatic Breast Carcinoma and Women Sexual Quality of Life (SexoMBC)

August 7, 2018 updated by: Institut de Cancérologie de Lorraine

Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

30

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
      • Vandœuvre-lès-Nancy, France
        • Institut de Cancerologie de Lorraine

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 to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The study will be offered to women aged 50 to 70, with metastatic breast carcinoma and living in a couple and followed at the Lorraine Institute of Oncology.

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 1 day
Quality of life will assessed by quality of life breast cancer module questionnaire (QLQ-BR23) (Hinz et al, 2014)
1 day
Quality of Relationship of the couple
Time Frame: 1 day
Quality of Relationship of the couple will assessed by partnership questionnaire (PFB). 30 items making up a global scale measuring the Quality of relationship (PFB).Quality of relationship (PFB) score can be obtained with the following equation: PFB = (30 - Quarreling) + Tenderness + Togetherness/communication ( Rossier et al, 2006).
1 day
Sexual and emotional intimacy
Time Frame: 1 day
Patients will be interviewed by open-ended questions face to face concerning their Sexual and emotional intimacy.
1 day

Collaborators and Investigators

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

Sponsor

Institut de Cancérologie de Lorraine

Investigators

  • Principal Investigator: Dubuc Myriam, Institut de Cancerologie de Lorraine

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)

March 12, 2018

Primary Completion (ACTUAL)

April 4, 2018

Study Completion (ACTUAL)

April 4, 2018

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

January 18, 2018

First Posted (ACTUAL)

January 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 7, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A03413-50

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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