Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-12-09
2028-06-09
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Center Eugene Marquis
OTHER
Responsible Party
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Principal Investigators
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Claudia Lefeuvre-Plesse, MD
Role: PRINCIPAL_INVESTIGATOR
Centre de Lutte Contre Le cancer Eugène Marquis
Locations
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Centre de Lutte contre le Cancer Eugène Marquis
Rennes, Brittany Region, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-A02035-40
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-4-72-002
Identifier Type: -
Identifier Source: org_study_id
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