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CompletedNCT03408769SexoMBCUpdated Aug 8, 2018

Metastatic Breast Carcinoma and Women Sexual Quality of Life

An observational study in Metastatic Breast Carcinoma, sponsored by Institut de Cancérologie de Lorraine. Completed at 1 site in France. Open to female participants aged 50 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-08-08.

Sponsored by Institut de Cancérologie de Lorraine · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
50 Years to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • 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)
03

Who can participate

Ages eligible
50 Years to 70 Years
Sexes eligible
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.

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

Exclusion Criteria:

  • Patient in exclusive palliative care
  • Single or not living in a couple
  • Non-menopausal patient
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (actual)
Patient registry
No

Interventions

  • OtherMedical 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

05

What researchers measure

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

    Time frame: 1 day

Secondary outcomes

  1. Quality of life

    Quality of life will assessed by quality of life breast cancer module questionnaire (QLQ-BR23) (Hinz et al, 2014)

    Time frame: 1 day

  2. 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).

    Time frame: 1 day

  3. Sexual and emotional intimacy

    Patients will be interviewed by open-ended questions face to face concerning their Sexual and emotional intimacy.

    Time frame: 1 day

06

Study locations

1 site
  • Institut de Cancérologie de Lorraine
    Vandœuvre-lès-Nancy, France
07

Registry details

Key details

Study ID
NCT03408769
Lead sponsor
Institut de Cancérologie de Lorraine
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
Mar 12, 2018
Primary completion
Apr 4, 2018
Completion
Apr 4, 2018
Last update
Aug 8, 2018

Study contacts

Dubuc Myriam
principal investigator · Institut de Cancérologie de Lorraine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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