Clinical trial NCT04852926: Study of the Sexual Health of Patients Treated for Breast Cancer and Followed up in the Observatory of Fertility at Jeanne de Flandre Hospital.
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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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:

-

Primary outcomes:
measure: variation of score FSFI (female sexual function index)
timeFrame: At 1 year after the start of chemotherapy
Secondary outcomes:
measure: 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.
timeFrame: At inclusion, at 1 year and 2 years after chemotherapy
measure: association between psychometric factors assessed prior to cancer diagnosis and sexual health progression at 1 year of chemotherapy initiation
timeFrame: At inclusion, at 1 year and 2 years after chemotherapy
measure: correlation between quality of life and psychometric factors and the assessment of sexual health of patients measured at all times.
timeFrame: At inclusion, at 1 year and 2 years after chemotherapy
measure: describe partners' sexual health by MSHQ (man)/FSFI (woman) during follow-up
timeFrame: 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,
measure: describe partners' sexual health by PEP (man)/FSFI (woman) during follow-up
timeFrame: 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,
measure: testimony of patients expressing their experience of follow-up in the Fertility Observatory
timeFrame: 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,
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: Carine Martin, MD
role: PRINCIPAL_INVESTIGATOR
References: