RecruitingNot ApplicableNCT06415266

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

Multicentric Randomized Study eValuating the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

264 participants

Start Date

Aug 9, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria3

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

Interventions

OTHERQuality 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).

OTHERSatisfaction 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).

OTHERAssessment 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.