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Clinical Trials in France / NCT06415266
Recruiting Not applicable

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

NCT06415266 · tracked via the Priya Life Science France tracker
Sponsor
Institut du Cancer de Montpellier - Val d'Aurelle
Phase
Not applicable
Started
2024-08-09
Last updated
2025-09-04

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Quality of life questionnaire (QLQ)Satisfaction surveyAssessment of patient needs in the field of oncosexology

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).

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).

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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
    EORTC Sexual Health Questionnaire (SHQ)-C22 specific questionnaire sexual satisfaction scale score. Questionnaire comprising 2 multi-item scales assessing sexual satisfaction and dyspareunia; as well as 11 single items (including: importance of sexual activity, libido, incontinence, fatigue, impact of treatment on sexual life, communication with professionals, partner); as well as 4 items related to gender: 2 specific items for women (body image, vaginal dryness); 2 specific items for men (body image, confidence in maintaining an erection). The score ranges from 0 to 100. A high scale score represents a higher response level.

Trial sites (9)

FacilityCityRegionStatus
Institut de Cancérologie de l'Ouest Saint-Herblain Saint Herblain Recruiting
Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy Vandoeuvre LES Nancy Recruiting
Centre Léon Bérard Lyon France Not Yet Recruiting
ICM Val d'Aurelle Montpellier France Recruiting
Centre Antoine Lacassagne Nice France Not Yet Recruiting
CHU de Nîmes Nîmes France Recruiting
Institut Curie Paris France Recruiting
IUCT - Oncopole Toulouse France Recruiting
Institut Gustave Roussy Villejuif France Recruiting

More Institut du Cancer de Montpellier - Val d'Aurelle trials in France

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Sequential Treatment With GEMBRAX and Then FOLFIRINOX Followed by Stereotactic MRI-guided Radiotherapy in Patients With Locally Advanced Pancreatic Cancer Recruiting
Study of Sexual Quality of Life in Women With Breast Cancer Who Had Multidisciplinary Management With Photobiomodulation for Genitourinary Syndrome of the Menopause Recruiting

Other trials for the same condition

Follow-up of Sequential Chemotherapy and Stimulation for Fertility Preservation in Young Patients With Breast Cancer Active, not recruiting
Theranostic Approach by Early Multigene Sequencing in Advanced Poor Prognosis Cancers Recruiting
Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Aromatase Inhibitor-induced Arthralgia (AIA) Starting soon
Personalization of Breast Radiotherapy According to Loco-regional Recurrence Risk and Toxicity Probability Recruiting
Efficacy and Safety of Non Invasive Vagal Stimulation to Prevent Chemotherapy-induced Nausea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06415266 on ClinicalTrials.gov ↗ ← All trials in France