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

NCT ID: NCT04852926

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-13

Study Completion Date

2025-06-13

Brief Summary

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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

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Conditions

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Breast Cancer Breast Neoplasms Breast Carcinoma Breast Tumor

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Self-administered questionnaires

Intervention Type 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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carine Martin, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2020-A00541-40

Identifier Type: OTHER

Identifier Source: secondary_id

2020_61

Identifier Type: -

Identifier Source: org_study_id