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

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.

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Neoplasms; Breast Carcinoma; Breast Tumor
• Intervention / Treatment: Other: Self-administered questionnaires

• Study Type: Observational
• Enrollment (Anticipated): 65

Contacts and Locations

• Study Contact: Name: Carine Martin, MD; Phone Number: +33 0320445962; Email: carine.martin@chru-lille.fr

Study Locations

• France
  • Lille, France, 59037
    • Recruiting
    • Hop Jeanne de Flandre Chu Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

• Refusal of oncologic treatments
• Other cancer than breast cancer
• Metastatic breast cancer
• Unable to receive informed information, unable to participate in the entire study, lack of social security coverage, refusal to sign consent
• Person under protection
• Minor
• Persons deprived of liberty
• Persons unable to consent

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

A prospective cohort of patients; Female patients treated for non-metastatic breast cancer and followed up in the Observatory of fertility at Jeanne de Flandre Hospital

Other: Self-administered questionnaires; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
variation of score FSFI (female sexual function index)	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.	At 1 year after the start of chemotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.		At inclusion, at 1 year and 2 years after chemotherapy
association between psychometric factors assessed prior to cancer diagnosis and sexual health progression at 1 year of chemotherapy initiation		At inclusion, at 1 year and 2 years after chemotherapy
correlation between quality of life and psychometric factors and the assessment of sexual health of patients measured at all times.		At inclusion, at 1 year and 2 years after chemotherapy
describe partners' sexual health by MSHQ (man)/FSFI (woman) during follow-up	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.	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,
describe partners' sexual health by PEP (man)/FSFI (woman) during follow-up	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.	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,
testimony of patients expressing their experience of follow-up in the Fertility Observatory		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,

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Carine Martin, MD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2021
• Primary Completion (Anticipated): July 1, 2025
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: April 15, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Quality of life; Breast cancer; Fertility preservation Quality of life Sexual health Marital satisfaction; Sexual health; Marital satisfaction
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2020_61; 2020-A00541-40 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

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