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Assessment the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request

The study compares the quality of sexual life of breast cancer patients under two types of oncoSexology supportive care : personalized supportive care versus on-request. The aim is to improve the quality of sexual life of these patients.

ClinicalTrials.gov IDNCT06415266

PhaseNA

Enrollment264

SponsorInstitut du Cancer de Montpellier - Val d'Aurelle

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

Interventions

Other: Quality of life questionnaire (QLQ) — Quality of life questionnaire : EORTC QLQ-C30, EORTC QLQ-Breast cancer module (BR) 23, EORTC SHQ-C22 et HADS at inclusion, visit 1 (6 months +/-1 month before the inclusion), visit 2 (12 months +/-1 month before the inclusion), visit 3 (18 months +/-1 month before the inclusion) and visit 4 (24 months +/-1 month before the inclusion).
Other: Satisfaction survey — The satisfaction score will be collected using a visual analog scale from 0 to 10 and the satisfaction questionnaire will also be completed at visit 4 (24 months +/- 1 month before the inclusion).
Other: Assessment of patient needs in the field of oncosexology — Assessment of patient needs in the field of oncosexology during a face-to-face or virtual interview at inclusion and every 6 months for 2 years. If a need is identified, an oncosexology consultation will be organised. Following this, a personalised care plan may be proposed.

Primary outcomes

Comparison of the quality of sexual life of patients in the intervention arm and patients in the control arm (at 12 months after the inclusion)

Eligibility information

Inclusion Criteria: * Woman or man at least 18 years old * Diagnosis of infiltrating breast cancer regardless of the biological characteristics of the tumor * Standard treatment by surgery, radiotherapy and/or chemotherapy, completed a maximum of 3 months ago with the exception of post-neoadjuvant treatments (chemotherapy, poly(ADP-ribose) polymerase (PARP) inhibitor, immunotherapy, targeted treatment, ...) which must have been started less than 3 months previously * Patient with sufficient command of the French language to be able to answer the questionnaires * Patient having given informed, written and express consent. * Affiliation to the French Social Security System * Willingness and ability to comply with scheduled visits, treatment plan and other study procedures Exclusion Criteria: * Patient already taken cared of in oncosexology. The following are not criteria for non-inclusion (a previous single consultation without treatment, use of local vaginal treatments) * Metastatic disease * Patient under guardianship, curatorship or safeguard of justice

Study locations

Institut de Cancérologie de l'Ouest, Saint-Herblain, Saint Herblain 44805 France
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy 54519 France
Centre Léon Bérard, Lyon, 69008 France
ICM Val d'Aurelle, Montpellier, 34298 France
Centre Antoine Lacassagne, Nice, 06189 France
CHU de Nîmes, Nîmes, 30029 France
Institut Curie, Paris, 75005 France
IUCT - Oncopole, Toulouse, 31100 France
Institut Gustave Roussy, Villejuif, 94800 France

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.