Systematic Intervention to Improve Sexual Dysfunction

Center Eugene Marquis60 enrolled

Overview

The aim of this clinical trial is to compare the benefit of early, systematic, multidisciplinary oncosexological care versus on-demand care on the sexual health of women with breast cancer.

The aim of the study is to evaluate the effectiveness of early, systematized oncosexology care on perceived sexual health at 18 months, compared with oncosexology care on demand. All included patients are evaluated at Baseline and M18 following initiation of antineoplastic treatments associated with surgery. Patients who accepted additional oncosexological care were also assessed at M4, M8 and M12. The content of support care is detailed in section "arms and interventions". Oncosexology consultations with the sexologist and the medical support care of any organic disorders remain accessible to all patients, on request, including the group of patients who do not wish to participate in early and systematic oncosexology care.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Breast Cancer Female Localized Cancer

Interventions

Early and systematic oncosexological supporting careOTHER

Each patient included in the study will be cared by an anthropologist and a sexologist. This therapeutic support care will be based on : * 2 qualitative semi-directive interviews (Baseline and M18), * 2 individual consultations with questionnaires (Baseline and M18). The qualitative semi-structured interviews will be conducted with the anthropologist, and the individual consultations with the sexologist. At the end of the first oncosexology consultation, patients will be given the opportunity to decide whether or not to accept further systematic oncosexology support care, which will be based on : * 3 individual and/or couple consultations, * 3 group workshops. Patients are under no obligation to accept this additional oncosexology support care.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women ≥ 18 years (menopausal or not), * Localized breast cancer with or without lymph node involvement, * Initial treatment starting with surgical resection, whatever the associated therapy (chemotherapy, radiotherapy, hormone therapy, monoclonal antibody, conjugated drug antibody, targeted therapy such as cyclin and anti-PARP inhibitors, etc.), * Patient affiliated or benefiting from the social security system, * Patient informed and informed consent signed. Exclusion Criteria: * History of cancer (except squamous cell carcinoma or basal cell carcinoma) in the last five years, * Pregnant or breast-feeding women, * Patients deprived of their liberty, under guardianship or curatorship and all other administrative safeguards, * Patients unable to comply with the study schedule for social, medical or psychological reasons.

Locations (1)

Centre de Lutte contre le Cancer Eugène Marquis

Rennes, Brittany Region, France

RECRUITING

Outcomes

Primary Outcomes

Sexual satisfaction

Sexual satisfaction score measured by self-questionnaire using the EORTC Quality of Life Questionnaire Sexual Health scale (EORTC QLQ-SH22).

Time frame: Measured at baseline and at 18 months following initiation of treatment and surgical.

Central Contacts

Marion Trochet

CONTACT

0299253165 m.trochet@rennes.unicancer.fr

Valérie Jolaine

CONTACT

0299253036 v.jolaine@rennes.unicancer.fr

Data from ClinicalTrials.gov

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