Systematic Intervention to Improve Sexual Dysfunction

NCT06583460 | Recruiting

• 2 other identifiers: 2023-4-72-0022023-A02035-40
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer Female; Localized Cancer

Keywords

Sexual dysfunction

Outcome Measures

Primary Outcomes (1)

• Sexual satisfaction

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

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

Study Arms (1)

Breast cancer treatment with oncosexology supporting care

OTHER

Patient initially treated by surgery combined with any therapy (chemotherapy, radiotherapy, hormonal therapy etc.) and benefiting oncosexological care.

Other: Early and systematic oncosexological supporting care

Interventions

Early and systematic oncosexological supporting care OTHER

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.

Breast cancer treatment with oncosexology supporting care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Center Eugene Marquis: lead

Study Sites (1)

Centre de Lutte contre le Cancer Eugène Marquis

Rennes, Brittany Region, 35042, France

RECRUITING

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Claudia Lefeuvre-Plesse, MD

  Centre de Lutte Contre Le cancer Eugène Marquis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marion Trochet

CONTACT

0299253165; m.trochet@rennes.unicancer.fr

Valérie Jolaine

CONTACT

0299253036; v.jolaine@rennes.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Category 2 clinical trial, monocentric, prospective, comparative, controlled but not randomized

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: September 4, 2024
• Study Start: December 9, 2024
• Primary Completion (Estimated): June 9, 2028
• Study Completion (Estimated): June 9, 2028
• Last Updated: August 5, 2025

Record last verified: 2025-08

Locations

FR (1)