Systematic Intervention to Improve Sexual Dysfunction (SISTER)
Systematic Intervention to Improve Sexual Dysfunction in Adjuvant Breast Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Brittany Region
-
Rennes, Brittany Region, France, 35042
- Centre de Lutte contre le Cancer Eugène Marquis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Measured at baseline and at 18 months following initiation of treatment and surgical.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Claudia Lefeuvre-Plesse, MD, Centre de Lutte contre le Cancer Eugène Marquis
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-4-72-002
- 2023-A02035-40 (Registry Identifier: IDRCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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