Trials Sponsors Conditions Drugs Pricing

Conditions

Breast Cancer Breast Carcinoma Breast Neoplasms Breast Tumor

Keywords

Breast cancerFertility preservation Quality of life Sexual health Marital satisfactionQuality of lifeSexual healthMarital 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

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 questionnairesOther

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexfemale(Gender-based eligibility)

Gender Eligibility DetailsFemale patients treated for non-metastatic breast cancer and followed up in the Observatory of fertility at Jeanne de Flandre Hospital.

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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:

Sponsors & Collaborators

University Hospital, Lille
Otherlead

Study Sites (1)

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

Carine Martin, MD
University Hospital, Lille
PRINCIPAL INVESTIGATOR

Enrollment

25 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

A prospective cohort of patients

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

A prospective cohort of patients

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations