ENVIE: 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 Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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)
|
Outcome Measures
Primary Outcome Measures
- variation of score FSFI (female sexual function index) [At 1 year after the start of chemotherapy]
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.
Secondary Outcome Measures
- 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,]
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.
- 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,]
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.
- 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,]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female from 18 years
-
In a relationship with a man or a woman
-
Developing invasive carcinoma of breast cancer
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Planned medical therapy project by chemotherapy
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Followed up in the Observatory of fertility
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Patient who gave written consent to participate in the study
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Insured Social Patient
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Patient willing to follow all study procedures and duration
Exclusion Criteria:
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hop Jeanne de Flandre Chu Lille | Lille | France | 59037 |
Sponsors and Collaborators
- University Hospital, Lille
Investigators
- Principal Investigator: Carine Martin, MD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020_61
- 2020-A00541-40