Breast CancerENVIENCT04852926
Study of the Sexual Health of Patients Treated for Breast Cancer and Followed up in the Observatory of Fertility at Jeanne de Flandre Hospital.
An observational study of Breast Cancer and Breast Neoplasms, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasms, Breast Carcinoma
- What is being tested?
- Self-administered questionnaires
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2021to 13 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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 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
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Carcinoma, Breast Tumor
- Being tested
- Self-administered questionnaires
- Keywords
- Breast cancer, Fertility preservation Quality of life Sexual health Marital satisfaction, Quality of life, Sexual health, Marital satisfaction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered questionnairesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Self-administered questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 1 year after the start of chemotherapy
Secondary outcomes (6)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start13 Jul 2021
- Primary completion13 Jun 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carine Martin, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852926
- Sponsor's protocol ID
- 2020_61
- Other IDs
- 2020-A00541-40
- Acronym
- ENVIE
- Status last verified
- Dec 2025
- First submitted
- 15 Apr 2021
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04852926
- Acronym / sponsor ID
- ENVIE / 2020_61
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A prospective cohort of patients | – | Other: Self-administered questionnairesFemale patients treated for non-metastatic breast cancer and followed up in the Observatory of fertility at Jeanne de Flandre Hospital |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered questionnaires6 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) | Other | A prospective cohort of patients |
Primary outcome
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.
6 secondary outcomes
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
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
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
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,
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,
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,
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carine Martin, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Neoplasms, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of score FSFI (female sexual function index) (time frame: At 1 year after the start of chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.