ClinicalTrials.gg
Active, not recruitingNCT06583460SISTERUpdated Oct 22, 2026

Systematic Intervention to Improve Sexual Dysfunction

An interventional study of Early and systematic oncosexological supporting care in Breast Cancer Female and Localized Cancer, sponsored by Center Eugene Marquis. Active, not recruiting at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Center Eugene Marquis · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

The aim of this clinical trial is to compare the benefit of early, systematic, multidisciplinary oncosexological care versus on-demand care on the sexual health of women with breast cancer.

Read the detailed description

The aim of the study is to evaluate the effectiveness of early, systematized oncosexology care on perceived sexual health at 18 months, compared with oncosexology care on demand.

All included patients are evaluated at Baseline and M18 following initiation of antineoplastic treatments associated with surgery. Patients who accepted additional oncosexological care were also assessed at M4, M8 and M12. The content of support care is detailed in section "arms and interventions".

Oncosexology consultations with the sexologist and the medical support care of any organic disorders remain accessible to all patients, on request, including the group of patients who do not wish to participate in early and systematic oncosexology care.

02

Conditions studied

  • Breast Cancer Female
  • Localized Cancer

Keywords

  • Sexual dysfunction
03

In context

Sexual Dysfunction, Physiological

385 studies on the registry are indexed under Sexual Dysfunction, Physiological; 72 are open to participants now.

This study's enrollment of 60 is below the median of 72 across 263 interventional studies indexed under Sexual Dysfunction, Physiological.

Browse Sexual Dysfunction, Physiological studies →

Lead sponsor

Center Eugene Marquis is the lead sponsor of 32 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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 ≥ 18 years (menopausal or not),
  • Localized breast cancer with or without lymph node involvement,
  • Initial treatment starting with surgical resection, whatever the associated therapy (chemotherapy, radiotherapy, hormone therapy, monoclonal antibody, conjugated drug antibody, targeted therapy such as cyclin and anti-PARP inhibitors, etc.),
  • Patient affiliated or benefiting from the social security system,
  • Patient informed and signed.

Exclusion criteria

Exclusion Criteria:

  • History of cancer (except squamous cell carcinoma or basal cell carcinoma) in the last five years,
  • Pregnant or breast-feeding women,
  • Patients deprived of their liberty, under guardianship or curatorship and all other administrative safeguards,
  • Patients unable to comply with the study schedule for social, medical or psychological reasons.
Terms in these criteria, in plain language(1)

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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Other
    Breast cancer treatment with oncosexology supporting care

    Patient initially treated by surgery combined with any therapy (chemotherapy, radiotherapy, hormonal therapy etc.) and benefiting oncosexological care.

    Other: Early and systematic oncosexological supporting care

Interventions

  • OtherEarly and systematic oncosexological supporting care

    Each patient included in the study will be cared by an anthropologist and a sexologist. This therapeutic support care will be based on : * 2 qualitative semi-directive interviews (Baseline and M18), * 2 individual consultations with questionnaires (Baseline and M18). The qualitative semi-structured interviews will be conducted with the anthropologist, and the individual consultations with the sexologist. At the end of the first oncosexology consultation, patients will be given the opportunity to decide whether or not to accept further systematic oncosexology support care, which will be based on : * 3 individual and/or couple consultations, * 3 group workshops. Patients are under no obligation to accept this additional oncosexology support care.

06

What researchers measure

Primary outcomes

  1. Sexual satisfaction

    Sexual satisfaction score measured by self-questionnaire using the EORTC Quality of Life Questionnaire Sexual Health scale (EORTC QLQ-SH22).

    Time frame: Measured at baseline and at 18 months following initiation of treatment and surgical.

07

Study locations

1 site
08

Timeline

1 registry update 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

Started Dec 2024 (actual). Primary completion is estimated for Jun 2028, 42 months after the start.

Of 100 non-industry interventional studies with no phase under Sexual Dysfunction, Physiological, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 42 months is above that.

Counting every sponsor, half of 112 studies reached it within 20 months; a quarter within 10 and three quarters within 43.

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

Registered
Aug 6, 2024
First posted
Sep 4, 2024
StartActual
Dec 9, 2024
Primary completionEst.
Jun 9, 2028
CompletionEst.
Jun 9, 2028
Last update
Oct 22, 2026
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.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT06583460
Lead sponsor
Center Eugene Marquis
Responsible party
Sponsor
First posted
Sep 4, 2024
Start date
Dec 9, 2024
Primary completion
Jun 9, 2028 (estimated)
Completion
Jun 9, 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Claudia Lefeuvre-Plesse, MD
principal investigator · Centre de Lutte Contre Le cancer Eugène Marquis

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 active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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