Improving sexual quality of life for breast cancer patients with supportive care
Multicentric Randomized Study eValuating the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request
This study tests whether personalized or on-request supportive care can improve the sexual quality of life for breast cancer patients after treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 264 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 9 sites (Saint-Herblain, Saint Herblain and 8 other locations) |
| Trial ID | NCT06415266 on ClinicalTrials.gov |
What this trial studies
This study compares the quality of sexual life in breast cancer patients receiving two types of oncoSexology supportive care: personalized care and on-request care. It aims to address the sexual health issues that arise post-cancer treatment, which can significantly affect overall quality of life. Patients will complete quality of life questionnaires at the start and every six months for two years to assess the impact of the interventions. The goal is to enhance the sexual well-being of patients during their recovery.
Who should consider this trial
Good fit: Ideal candidates are women or men aged 18 and older who have been diagnosed with infiltrating breast cancer and have completed standard treatment within the last three months.
Not a fit: Patients with metastatic breast cancer or those already receiving oncosexology care may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the sexual quality of life for breast cancer patients.
How similar studies have performed: Other studies have shown success in improving quality of life for cancer patients through supportive care, making this approach promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Saint-Herblain, Saint Herblain and 8 other locations
- Institut de Cancérologie de l'Ouest — Saint-Herblain, Saint Herblain, France (Recruiting)
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy, France (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)
Study contacts
- Principal investigator: Véronique D'HONDT, Dr — Institut du Cancer de Montpellier (ICM)
- Study coordinator: Aurore MOUSSION
- Email: DRCI-icm105@icm.unicancer.fr
- Phone: 04 67 61 31 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.