Systematic Intervention to Improve Sexual Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early and systematic oncosexological supporting care.
- Who it may be relevant to
- Registry conditions: Breast Cancer Female, Localized Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Systematic Intervention to Improve Sexual Dysfunction in Adjuvant Breast Cancer Patients
Overview
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.
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.
Interventions
- 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 opportunit
Primary outcome measures
- Sexual satisfaction [Time frame: Measured at baseline and at 18 months following initiation of treatment and surgical.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 1 center
- Centre de Lutte contre le Cancer Eugène Marquis — Rennes
Identifiers
NCT: NCT06583460 · 2023-4-72-002 · 2023-A02035-40