ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 20 studies in Breast Neoplasms by Institut de Cancérologie de Lorraine — 1 open to participants now, 2 under way, none of them phase 3. Breast Neoplasms · Institut de Cancérologie de Lorraine.

Started
2018
with 1 other
Observational
6 of 20
none open now
Registered
13th of 20
by date

Among the 20 studies in Breast Neoplasms by Institut de Cancérologie de Lorraine, this one is one of 2 that started in 2018, is one of 6 observational ones, and was the 13th registered.

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

Browse Breast Neoplasms studies →

Open to participants now

1 of the 20 studies in Breast Neoplasms by Institut de Cancérologie de Lorraine is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.

This study: 50 Years to 70 Years · female · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 20 studies in Breast Neoplasms by Institut de Cancérologie de Lorraine, or all of them as a file.
02

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.

03

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)
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women with 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)
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

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

06

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

07

Study locations

1 site
  • Institut de Cancérologie de Lorraine
    Vandœuvre-lès-Nancy, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Apr 2018, 0 months.

Of 1,191 non-industry observational studies under Breast Neoplasms, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 139. This study's 0 months is below that.

Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2018
First posted
Jan 24, 2018
StartActual
Mar 12, 2018
Primary completionActual
Apr 4, 2018
CompletionActual
Apr 4, 2018
Last update
Aug 8, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

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 ↗

Not currently enrolling

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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Discussion

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