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Trial Title:
Systematic Intervention to Improve Sexual Dysfunction
NCT ID:
NCT06583460
Condition:
Breast Cancer Female
Localized Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Sexual dysfunction
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Category 2 clinical trial, monocentric, prospective, comparative, controlled but not
randomized
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Early and systematic oncosexological supporting care
Description:
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.
Arm group label:
Breast cancer treatment with oncosexology supporting care
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre de Lutte contre le Cancer Eugène Marquis
Address:
City:
Rennes
Zip:
35042
Country:
France
Contact:
Last name:
Marion Trochet
Phone:
02 99 25 31 65
Phone ext:
+33
Email:
m.trochet@rennes.unicancer.fr
Contact backup:
Last name:
Valérie Jolaine
Phone:
02 99 25 30 36
Phone ext:
+33
Email:
v.jolaine@rennes.unicancer.fr
Investigator:
Last name:
Claudia Lefeuvre-Plesse, MD
Email:
Principal Investigator
Start date:
November 25, 2024
Completion date:
January 15, 2028
Lead sponsor:
Agency:
Center Eugene Marquis
Agency class:
Other
Source:
Center Eugene Marquis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06583460
