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

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

Plain Language Summary

Simplified for easier understanding

This study is looking at whether proactively offering sexual health support (oncosexology) to breast cancer patients — rather than waiting until they ask — leads to better outcomes for their sexual quality of life. Many cancer treatments can affect sexual wellbeing, and this trial aims to understand the best way to address that. **You may be eligible if...** - You are 18 or older (any gender) - You have been diagnosed with invasive breast cancer - You completed main treatments (surgery, radiotherapy, or chemotherapy) no more than 3 months ago, OR you recently started post-surgery treatments like immunotherapy within the last 3 months - You speak French well enough to fill out questionnaires - You are covered by French Social Security - You are willing to follow the study schedule **You may NOT be eligible if...** - You are already receiving ongoing sexual health support from a specialist - You have metastatic (spread) breast cancer - You are under legal guardianship Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(9)

Institut de Cancérologie de l'Ouest

Saint-Herblain, Saint Herblain, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Vandoeuvre LES Nancy, France

Centre Léon Bérard

Lyon, France

ICM Val d'Aurelle

Montpellier, France

Centre Antoine Lacassagne

Nice, France

CHU de Nîmes

Nîmes, France

Institut Curie

Paris, France

IUCT - Oncopole

Toulouse, France

Institut Gustave Roussy

Villejuif, France

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NCT06415266


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