Systematic Intervention to Improve Sexual Dysfunction
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorCenter Eugene Marquis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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
Design model
Single group
Treatments tested in this trial
Early and systematic oncosexological supporting care
Other interventionEach 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Breast cancer treatment with oncosexology supporting careOther 1 intervention
Trial outcomes
Primary outcomes
1
Sexual satisfaction
Sexual satisfaction score measured by self-questionnaire using the EORTC Quality of Life Questionnaire Sexual Health scale (EORTC QLQ-SH22).
Time frame
Measured at baseline and at 18 months following initiation of treatment and surgical.Sponsors and contacts
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Source ClinicalTrials.gov