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NCT Number: NCT04852926

Study of the Sexual Health of Patients Treated for Breast Cancer and Followed up in the Observatory of Fertility at Jeanne de Flandre Hospital.

Study of sexual health by repeated anonymous self-administered questionnaires in patients treated for non-metastatic breast cancer and referred to Jeanne de Flandre hospital for possible preservation of their fertility. Sexual health is affected by treatments and improves after the treatments. Sexual health is influenced by multiple factors : oncology treatments received, self-esteem, body image, anxiety, depression, professional activity

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Key information

Conditions

Breast Cancer Breast Carcinoma Breast Diseases Breast Neoplasms Breast Tumor Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female from 18 years
  • In a relationship with a man or a woman
  • Developing invasive carcinoma of breast cancer
  • Planned medical therapy project by chemotherapy
  • Followed up in the Observatory of fertility
  • Patient who gave written consent to participate in the study
  • Insured Social Patient
  • Patient willing to follow all study procedures and duration

Exclusion criteria

-

Treatment and study plan

self-administered questionnaires

Other

6 self-administered questionnaires (EORTC-QLQ-C30, RSE, BIS, HAD, FSFI, DAS-4) completed by the patients at every usual follow-up consultation.

1 (FSFI) or 2 (MSHQ, PEP) self-administered questionnaires completed by the partner (respectively female or male) between every usual follow-up consultation.

Follow-up usual consultations :

  • T0 (at inclusion) : before disease + since diagnosis
  • C4 (chemotherapy course n°4)
  • C6 (chemotherapy course n°6)
  • M3 (3 months after chemotherapy)
  • M6 (6 months after chemotherapy)
  • A1 (1 year after chemotherapy)
  • A2 (2 years after chemotherapy)

Primary outcomes

  1. variation of score FSFI (female sexual function index)

    Time frame: At 1 year after the start of chemotherapy

    The FSFI score assesses female sexual functioning over the past four weeks. It is a self-evaluation by questionnaire. It consists of 19 questions with 5 or 6 possible answers per question, scored respectively from 1 to 5 and from 0 To evaluate, in women with non-metallic breast cancer followed in the Fertility Observatory at the Jeanne de Flandre Hospital, 1-year sexual health progression from chemotherapy initiation to sexual health assessment prior to cancer diagnosis announcement.

Secondary outcomes

  1. evolution of quality of life and psychometric factors at 1 year from the start of chemotherapy compared to the evaluation of these factors before the cancer diagnosis is announced.

    Time frame: At inclusion, at 1 year and 2 years after chemotherapy

  2. association between psychometric factors assessed prior to cancer diagnosis and sexual health progression at 1 year of chemotherapy initiation

    Time frame: At inclusion, at 1 year and 2 years after chemotherapy

  3. correlation between quality of life and psychometric factors and the assessment of sexual health of patients measured at all times.

    Time frame: At inclusion, at 1 year and 2 years after chemotherapy

  4. describe partners' sexual health by MSHQ (man)/FSFI (woman) during follow-up

    Time frame: At inclusion, at chemotherapy course n°4, at chemotherapy course n°6, at 3 months and at 6 months after chemotherapy, at 1 year and 2 years after chemotherapy,

    MSHQ (Male Sexual Health Questionnaire) consists of 25 questions. It is a self-evaluation by the partner. A total score out of 125 is calculated. A high score corresponds to a good quality of male sexual life.

  5. describe partners' sexual health by PEP (man)/FSFI (woman) during follow-up

    Time frame: At inclusion, at chemotherapy course n°4, at chemotherapy course n°6, at 3 months and at 6 months after chemotherapy, at 1 year and 2 years after chemotherapy,

    The PEP (Premature ejaculation profile) score explores premature ejaculation by self-questionnaire. It consists of 4 questions scored from 1 to 5. A high score corresponds to good male sexual health. A low score indicates premature ejaculation with repercussions on male sexual health.

  6. testimony of patients expressing their experience of follow-up in the Fertility Observatory

    Time frame: At inclusion, at chemotherapy course n°4, at chemotherapy course n°6, at 3 months and at 6 months after chemotherapy, at 1 year and 2 years after chemotherapy,

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Study of the Sexual Health of Patients Treated for Non-metastatic Breast Cancer and Followed up in the Observatory of Fertility at Jeanne de Flandre Hospital : a Prospective Monocentric Cohort With Repeated Anonymous Self-administered Questionnaires.

Acronym: ENVIE

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Apr 21, 2021
Registry last updated
Dec 26, 2025

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.

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