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

Recruiting

• Conditions: Breast Tumor; Breast Cancer; Breast Neoplasms; Breast Carcinoma
• Interventions: Other: Self-administered questionnaires

• Registration Number: NCT04852926
• Lead Sponsor: University Hospital, Lille

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-04-15
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-21
• Study Start: 2021-07-13
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-17
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A prospective cohort of patients	Self-administered questionnaires	Female patients treated for non-metastatic breast cancer and followed up in the Observatory of fertility at Jeanne de Flandre Hospital

Primary Outcome Measures

Name	Time	Method
variation of score FSFI (female sexual function index)	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 Outcome Measures

Name	Time	Method
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
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,
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	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.
describe partners' sexual health by PEP (man)/FSFI (woman) during follow-up	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.

Trial Locations

Locations (1)

Hop Jeanne de Flandre Chu Lille; 🇫🇷 Lille, France