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

Study Overview
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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

Official Title
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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.

Conditions
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Breast Cancer, Breast Neoplasms, Breast Carcinoma, Breast Tumor

Intervention / Treatment
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* Other: Self-administered questionnaires


Participation Criteria
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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: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A prospective cohort of patients<br>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<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 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. | 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, | 
| 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, | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Fertility preservation Quality of life Sexual health Marital satisfaction, Quality of life, Sexual health, Marital satisfaction