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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02035-40 | Registry Identifier | IDRCB |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 :
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 :
Patients are under no obligation to accept this additional oncosexology support care. |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual satisfaction | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marion Trochet | Contact | 0299253165 | +33 | m.trochet@rennes.unicancer.fr |
| Valérie Jolaine | Contact | 0299253036 | +33 | v.jolaine@rennes.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Claudia Lefeuvre-Plesse, MD | Centre de Lutte Contre Le cancer Eugène Marquis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Lutte contre le Cancer Eugène Marquis | Recruiting | Rennes | Brittany Region | 35042 | France |
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| ID | Term |
|---|---|
| D012735 | Sexual Dysfunction, Physiological |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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Category 2 clinical trial, monocentric, prospective, comparative, controlled but not randomized
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