Breast Cancer Female, Localized Cancer
Conditions
Keywords
Sexual dysfunction
Brief summary
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
OTHEREarly 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.
Sponsors
Center Eugene Marquis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Category 2 clinical trial, monocentric, prospective, comparative, controlled but not randomized
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sexual satisfaction | 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). |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORClaudia Lefeuvre-Plesse, MD
Centre de Lutte Contre Le cancer Eugène Marquis
Outcome results
None listed