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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03408769
Recruitment Status : Completed
First Posted : January 24, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Institut de Cancérologie de Lorraine

Study Description
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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.


Condition or disease Intervention/treatment
Metastatic Breast Carcinoma Other: Medical questionnaire

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 Design
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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life
Actual Study Start Date : March 12, 2018
Actual Primary Completion Date : April 4, 2018
Actual Study Completion Date : April 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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).

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408769


Locations
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France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
Sponsors and Collaborators
Institut de Cancérologie de Lorraine
Investigators
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Principal Investigator: Dubuc Myriam Institut de Cancérologie de Lorraine
More Information
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Responsible Party: Institut de Cancérologie de Lorraine
ClinicalTrials.gov Identifier: NCT03408769    
Other Study ID Numbers: 2017-A03413-50
First Posted: January 24, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut de Cancérologie de Lorraine:
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)
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
 Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases