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NCT Number: NCT06583460

Systematic Intervention to Improve Sexual Dysfunction

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Early and systematic oncosexological supporting care

Other

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.

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Marion Trochet

CONTACT

[email protected]

0299253165 ext. +33

Valérie Jolaine

CONTACT

[email protected]

0299253036 ext. +33

Sponsors and collaborators

Lead sponsor

Center Eugene Marquis

Other

Registry information

Official study title

Systematic Intervention to Improve Sexual Dysfunction in Adjuvant Breast Cancer Patients

Acronym: SISTER

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 4, 2024
Registry last updated
Aug 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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