Systematic Intervention to Improve Sexual Dysfunction (SISTER)

August 4, 2025 updated by: Center Eugene Marquis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Bretagne
      • Rennes, Bretagne, France, 35042
        • Recruiting
        • Centre de lutte contre le cancer Eugène Marquis
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudia LEFEUVRE-PLESSE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 informed consent signed.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Center Eugene Marquis

Investigators

  • Principal Investigator: Claudia Lefeuvre-Plesse, MD, Centre de lutte contre le cancer Eugène Marquis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2024

Primary Completion (Estimated)

June 9, 2028

Study Completion (Estimated)

June 9, 2028

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

September 2, 2024

First Posted (Actual)

September 4, 2024

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-4-72-002
  • 2023-A02035-40 (Registry Identifier: IDRCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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