Evaluation of Sexual Quality of Life for Breast Cancer

NCT04200001 | Completed

• 1 other identifier: PROICM 2019-16-BCU
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most common cancer in women worldwide. Hormonal therapy is one of the major treatments for hormone receptor positive breast tumors. It is prescribed to 70% of breast cancer patients. Hormonal therapy can be responsible for sexual dysfunction induced by hormonal changes. Extended adjuvant hormonal therapy over 5 years increases these adverse effects. According to the third "Plan Cancer" (2014-2019), sexual dysfunction prevention and screening must be systematic as an integral part of supportive care. Nevertheless, sexual quality of life remains too rarely considered. In this study, the investigator propose to evaluate sexual quality of life of women less than 51 years old during the adjuvant endocrine therapy for localized breast cancer. The investigator also intend to collect the supportive measures or interventions used by women to overcome sexual dysfunction. Finally, this study aims to evaluate the need for sexual trouble specific management and acceptability of different methods. This project is a hot topic as the interest for oncosexuality is growing, and the need for specific management is increasing with still insufficient access to specific care.

Conditions

Breast Cancer; Cancer; Quality of Life

Keywords

breast cancer; hormonotherapy; women; quality of life

Outcome Measures

Primary Outcomes (1)

• Sexual quality of life: EORTC SHQ-C22 questionnaire

  Sexual quality of life assessed by the EORTC SHQ-C22 questionnaire

  At the inclusion, at one time

Study Arms (1)

adjuvant hormonal therapy for breast cancer

women less than 51 years old, during adjuvant hormonal therapy for breast cancer

Other: Quality of life

Interventions

Quality of life OTHER

The patient will receive the following questionnaires to be completed : * EORTC QLQ-C30 * EORTC QLQ-BR23 * EORTC SHQ-C22 * CUPIDON 2 specific questionnaire

adjuvant hormonal therapy for breast cancer

Eligibility Criteria

• Age: 18 Years - 51 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women less than 51 years old, during adjuvant hormonal therapy for breast cancer.

You may qualify if:

• Female age ≥ 18 years old and less than 51 years old.
• Patient with non-metastatic early breast cancer,
• Patient undergoing adjuvant hormonal therapy for at least 2 years,
• Patient who has been treated by surgery, with or without chemotherapy and/or radiotherapy.
• Patient being currently sexually active.
• Patient who agreed, after receiving information, to participate to the study.

You may not qualify if:

• Patient who refused to participate to this study or is unable to fulfill a questionnaire,
• Patient not affiliated to the French social security system,
• Subject under tutelage, curatorship or safeguard of justice,
• Patient in an emergency situation,
• Patient whose regular monitoring is impossible for psychological, family, social or geographical reasons,
• Pregnant and / or breastfeeding woman.

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Institut régional du Cancer de Montpellier

Montpellier, 34298, France

Location

Related Publications (2)

• Pouget JP, Lozza C, Deshayes E, Boudousq V, Navarro-Teulon I. Introduction to radiobiology of targeted radionuclide therapy. Front Med (Lausanne). 2015 Mar 17;2:12. doi: 10.3389/fmed.2015.00012. eCollection 2015.

  PMID: 25853132 BACKGROUND

• Kumar C, Shetake N, Desai S, Kumar A, Samuel G, Pandey BN. Relevance of radiobiological concepts in radionuclide therapy of cancer. Int J Radiat Biol. 2016;92(4):173-86. doi: 10.3109/09553002.2016.1144944. Epub 2016 Feb 26.

  PMID: 26917443 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Véronique D'HONDT, MD

  Institut Régional du Cancer de Montpellier (ICM)

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 16, 2019
• Study Start: February 10, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: March 1, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)