Breast Cancer FemaleSISTERNCT06583460

Systematic Intervention to Improve Sexual Dysfunction

A study testing Early and systematic oncosexological supporting care in people with Breast Cancer Female and Localized Cancer, run by Center Eugene Marquis at 1 site in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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 more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer Female, Localized Cancer
What is being tested?: Early and systematic oncosexological supporting care
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteFrance
Study dates: 9 Dec 2024to 9 Jun 2028
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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 informed consent signed.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

France1 site

Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, 35042

Other trials in France

About this study

Official title: Systematic Intervention to Improve Sexual Dysfunction in Adjuvant Breast Cancer Patients

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.

Conditions: Breast Cancer Female, Localized Cancer
Being tested: Early and systematic oncosexological supporting care
Keywords: Sexual dysfunction
Medical subject headings: Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Early and systematic oncosexological supporting careOther
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.

Study groups in NCT06583460
Study group	Role	What they receive
Breast cancer treatment with oncosexology supporting care	Other	Patient initially treated by surgery combined with any therapy (chemotherapy, radiotherapy, hormonal therapy etc.) and benefiting oncosexological care. Receives: Other: Early and systematic oncosexological supporting care

What is being measured

The primary outcome is the main question the study is designed to answer.

Sexual satisfaction
Sexual satisfaction score measured by self-questionnaire using the EORTC Quality of Life Questionnaire Sexual Health scale (EORTC QLQ-SH22).
Measured: Measured at baseline and at 18 months following initiation of treatment and surgical.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 20249 Jun 2028

First posted4 Sep 2024
Study start9 Dec 2024
Primary completion9 Jun 2028 (estimated)
Study completion9 Jun 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: Category 2 clinical trial, monocentric, prospective, comparative, controlled but not randomized
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06583460
Sponsor's protocol ID: 2023-4-72-002
Other IDs: 2023-A02035-40
Acronym: SISTER
Status last verified: Oct 2026
First submitted: 6 Aug 2024
Last updated: 22 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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