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

Breast Cancer Clinical Trial

— ENVIE  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04852926
• Other study ID #: 2020_61
• Secondary ID: 2020-A00541-40
• Status: Recruiting
• Start date: July 13, 2021
• Est. completion date: July 2025

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: Carine Martin, MD
• Phone: 0320445962
• Email: carine.martin[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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: -

Related Conditions & MeSH terms

• Breast Cancer
• Breast Carcinoma
• Breast Neoplasms
• Breast Tumor

Intervention

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)

Locations

Country	Name	City	State
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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,
Secondary	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,
Secondary	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,