Systematic Intervention to Improve Sexual Dysfunction (SISTER)

Center Eugene Marquis

Status: Enrolling

Conditions: Breast Cancer Female; Localized Cancer

Treatments: Other: Early and systematic oncosexological supporting care

Study type: Interventional

Funder types: Other

Identifiers

NCT06583460

2023-A02035-40 (Registry Identifier)

2023-4-72-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Breast cancer treatment with oncosexology supporting care

Other group

Description:

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

Treatment:

Other: Early and systematic oncosexological supporting care