Multicentric Randomized Study eValuating the sExual Quality of Life in Breast Cancer Patients Receiving oncoSexology Supportive Care on Proactive Versus On-request
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
- Enrollment
- 264
- Locations
- 9
- Primary Endpoint
- Comparison of the quality of sexual life of patients in the intervention arm and patients in the control arm
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief 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.
Detailed Description
Breast cancer and its treatment are responsible for symptoms that can persist over time and affect quality of life. Given the improved prognosis for breast cancer, more and more patients are faced with the specific problems of the post-cancer period, and caring for them has become a major health issue. Sexual health is a crucial component of well-being and overall quality of life. 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. For that, quality of life questionnaires will be completed by patients at inclusion and every 6 months for 2 years.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
Comparison of the quality of sexual life of patients in the intervention arm and patients in the control arm
Time Frame: 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.
Secondary Outcomes
- Description of evolution in sexual quality of life(at inclusion, 6,12,18, and 24 months before inclusion)
- Description of evolution in quality of life - QLQ-C30(at inclusion, 6,12,18, and 24 months before inclusion)
- Description of evolution in quality of life - QLQ-Breast (BR)cancer module 23 questionnaires.(at inclusion, 6,12,18, and 24 months before inclusion)
- Search for associations between comorbidities and risk factors(at inclusion, 6,12,18, and 24 months before inclusion)
- Assessment of adherence to the programme in the interventional arm(at inclusion)
- Search for associations between comorbidities and risk factors -questionnaire(at inclusion, 6,12,18, and 24 months before inclusion)
- Oncosexology programme satisfaction(at 24 months before inclusion)