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

Institut du Cancer de Montpellier - Val d'Aurelle

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: Assessment of patient needs in the field of oncosexology; Other: Satisfaction survey; Other: Quality of life questionnaire (QLQ)

Study type: Interventional

Funder types: Other

Identifiers

NCT06415266

PROICM 2023-07 VEN

2023-A02474-41 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 264 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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264 participants in 2 patient groups

Patients receiving oncoSexology supportive care on proactive

Experimental group

Description:

Repeated assessment of the patient's needs in the field of oncosexology. Proposal of a personalized care plan to meet the various needs identified.

Treatment:

Other: Satisfaction survey

Other: Quality of life questionnaire (QLQ)

Other: Assessment of patient needs in the field of oncosexology

Patients receiving oncoSexology supportive care on request

Other group

Description:

One-off distribution of a flyer to the patient containing both general information on sexual health and contact telephone numbers and e-mail addresses for oncosexology help

Treatment:

Other: Satisfaction survey

Other: Quality of life questionnaire (QLQ)