Metastatic Breast Carcinoma and Women Sexual Quality of Life
SexoMBC
Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2018
CompletedFirst Posted
Study publicly available on registry
January 24, 2018
CompletedStudy Start
First participant enrolled
March 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 4, 2018
CompletedAugust 8, 2018
August 1, 2018
23 days
January 18, 2018
August 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Quality of life
1 day
Quality of Relationship of the couple
1 day
Sexual and emotional intimacy
1 day
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
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patient in exclusive palliative care
- Single or not living in a couple
- Non-menopausal patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dubuc Myriam
Institut de Cancérologie de Lorraine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 18, 2018
First Posted
January 24, 2018
Study Start
March 12, 2018
Primary Completion
April 4, 2018
Study Completion
April 4, 2018
Last Updated
August 8, 2018
Record last verified: 2018-08