Skip to content

Metastatic Breast Carcinoma and Women Sexual Quality of Life

Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03408769
Acronym
SexoMBC
Enrollment
30
Registered
2018-01-24
Start date
2018-03-12
Completion date
2018-04-04
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Carcinoma

Keywords

Cancer, Sexuality, Quality of life, Intimacy, BISF-WBrief Index of Sexual Functioning for Women questionnaire, Quality of life questionnaire (EORTC QLQ-BR23):, Partnership questionnaire (partnerschaftsfragebogen; PFB)

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.

Interventions

* 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

Sponsors

Institut de Cancérologie de Lorraine
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quality of sexual life of postmenopausal women with metastatic breast carcinoma living in couples1 dayQuality of sexual life will assessed by BISF-W (Brief index of sexual functioning for women) questionnaire

Secondary

MeasureTime frameDescription
Quality of life1 dayQuality of life will assessed by quality of life breast cancer module questionnaire (QLQ-BR23) (Hinz et al, 2014)
Quality of Relationship of the couple1 dayQuality 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).
Sexual and emotional intimacy1 dayPatients will be interviewed by open-ended questions face to face concerning their Sexual and emotional intimacy.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026