Evaluation of Sexual Quality of Life for Breast Cancer (CUPIDON2)

Evaluation of Sexual Quality of Life in Women Less Than 51 Years Old, During Adjuvant Hormonal Therapy for Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Cancer; Breast Cancer
• Intervention / Treatment: Other: Quality of life

Detailed Description

In 2006, the World Health Organization provided a definition of sexual health stating that "for sexual health to be reached and maintained, the sexual rights of all persons must be respected and fulfilled". Sexual quality of life is now an admitted and relevant parameter of global health and global quality of life.

The VICAN 2 (Vie après le CANcer 2 years after diagnosis) survey showed that 2/3 of the sexually active French breast cancer survivors reported impaired sexual health, persisting 2 years after cancer diagnosis.

The deterioration of sexual health is multifactorial: (1) psychological: body image, sexual identity; (2) physiological: sexual functionality, steps of the feminine sexual response; (3) familial, social and professional. The alteration of sexuality is mainly due to cancer treatments: surgery, radiotherapy, chemotherapy and endocrine therapy.

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34298
    • Institut Régional du Cancer de Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
adjuvant hormonal therapy for breast cancer; women less than 51 years old, during adjuvant hormonal therapy for breast cancer	Other: Quality of life; The patient will receive the following questionnaires to be completed : EORTC QLQ-C30; EORTC QLQ-BR23; EORTC SHQ-C22; CUPIDON 2 specific questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): July 31, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 13, 2019
• First Posted (Actual): December 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2021
• Last Update Submitted That Met QC Criteria: February 26, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: breast cancer; quality of life; women; hormonotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PROICM 2019-16-BCU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No