Systematic Intervention to Improve Sexual Dysfunction in Adjuvant Breast Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Center Eugene Marquis
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Sexual satisfaction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single group
- Primary Purpose
- Supportive care
- Masking
- None (open label)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
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.
Intervention: Early and systematic oncosexological supporting care (Other)
Outcomes
Primary Outcomes
Sexual satisfaction
Time Frame: 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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Identifiers
- NCT ID
- NCT06583460
- Other Study IDs
- 2023-4-72-002, 2023-A02035-40
Dates
- First Submitted
- (2 years ago)
- First Posted
- (2 years ago)
- Primary Completion
- (next year)
- Study Completion
- (next year)
- Last Verified
- (last year)
- Last updated
- (last month)
Regulatory & Sharing
- FDA Regulated Drug
- No
- FDA Regulated Device
- No
- IPD Sharing Plan
- No
- Has Results
- No