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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. (ENVIE)

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ClinicalTrials.gov Identifier: NCT04852926
Recruitment Status : Not yet recruiting
First Posted : April 21, 2021
Last Update Posted : April 21, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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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
Breast Cancer Breast Neoplasms Breast Carcinoma Breast Tumor Other: Self-administered questionnaires

Study Design
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Study Type : Observational
Estimated Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort 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
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Primary Outcome Measures :
  1. variation of score FSFI (female sexual function index) [ Time Frame: 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 :
  1. 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. [ Time Frame: At inclusion, at 1 year and 2 years after chemotherapy ]
  2. association between psychometric factors assessed prior to cancer diagnosis and sexual health progression at 1 year of chemotherapy initiation [ Time Frame: At inclusion, at 1 year and 2 years after chemotherapy ]
  3. correlation between quality of life and psychometric factors and the assessment of sexual health of patients measured at all times. [ Time Frame: At inclusion, at 1 year and 2 years after chemotherapy ]
  4. describe partners' sexual health by MSHQ (man)/FSFI (woman) during follow-up [ Time Frame: 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.

  5. describe partners' sexual health by PEP (man)/FSFI (woman) during follow-up [ Time Frame: 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.

  6. testimony of patients expressing their experience of follow-up in the Fertility Observatory [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female patients treated for non-metastatic breast cancer and followed up in the Observatory of fertility at Jeanne de Flandre Hospital.
Accepts Healthy Volunteers:   No
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
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:

-

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852926


Contacts
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Contact: Carine Martin, MD 0320445962 ext +33 carine.martin@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Carine Martin, MD University Hospital, Lille
More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04852926    
Other Study ID Numbers: 2020_61
2020-A00541-40 ( Other Identifier: ID-RCB number,ANSM )
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: April 21, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Breast cancer
Fertility preservation Quality of life Sexual health Marital satisfaction
Quality of life
Sexual health
Marital satisfaction
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases