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NCT03408769 Clinical Trial

Metastatic Breast Carcinoma and Women Sexual Quality of Life

Metastatic Breast Carcinoma Clinical Trial

— SexoMBC  

Official title:
Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03408769
Other study ID # 2017-A03413-50
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 12, 2018
Est. completion date April 4, 2018

Study information
Verified date August 2018
Source Institut de Cancérologie de Lorraine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date April 4, 2018
Est. primary completion date April 4, 2018
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• 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

Locations
Country Name City State
France Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy

Sponsors (1)
Lead Sponsor Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of sexual life of postmenopausal women with metastatic breast carcinoma living in couples Quality of sexual life will assessed by BISF-W (Brief index of sexual functioning for women) questionnaire 1 day
Secondary Quality of life Quality of life will assessed by quality of life breast cancer module questionnaire (QLQ-BR23) (Hinz et al, 2014) 1 day
Secondary Quality of Relationship of the couple 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
Secondary Sexual and emotional intimacy Patients will be interviewed by open-ended questions face to face concerning their Sexual and emotional intimacy. 1 day
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