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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04852926
Other study ID # 2020_61
Secondary ID 2020-A00541-40
Status Recruiting
Phase
First received
Last updated
Start date July 13, 2021
Est. completion date July 2025

Study information

Verified date March 2022
Source University Hospital, Lille
Contact Carine Martin, MD
Phone 0320445962
Email carine.martin@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 65
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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: -

Study Design


Intervention

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)

Locations

Country Name City State
France Hop Jeanne de Flandre Chu Lille Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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,
Secondary 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,
Secondary 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,
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