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

NCT04852926 | Completed

• 2 other identifiers: 2020_612020-A00541-40
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Breast Neoplasms; Breast Carcinoma; Breast Tumor

Keywords

Breast cancer; Fertility preservation Quality of life Sexual health Marital satisfaction; Quality of life; Sexual health; Marital satisfaction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  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

  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,

Study Arms (1)

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

Interventions

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)

A prospective cohort of patients

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female patients treated for non-metastatic breast cancer and followed up in the Observatory of fertility at Jeanne de Flandre Hospital.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Carine Martin, MD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: April 21, 2021
• Study Start: July 13, 2021
• Primary Completion: June 13, 2025
• Study Completion: June 13, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Locations

FR (1)