Skip to main content
OpenTrials
Completed

NCT Number: NCT04200001

Evaluation of Sexual Quality of Life 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–51 year

Sex eligibility

Female

Study type

Observational

Primary location

Institut régional du Cancer de Montpellier

Montpellier, 34298, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Sexual quality of life: EORTC SHQ-C22 questionnaire

    Time frame: At the inclusion, at one time

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

Sponsors and collaborators

Lead sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Other

Registry information

Official study title

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

Acronym: CUPIDON2

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 16, 2019
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.