Breast CancerSexoMBC2NCT05577156
SexoMBC2 Non Interventional Study
An observational study of Breast Cancer and Quality of Life, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
The study is composed of three paper self-questionnaires to be filled in by the patients included at distance (> 6 months) from their diagnosis of metastatic breast cancer, in order to limit the impact of the announcement on the filling out the questionnaires. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Quality of Life, Sexual Behavior
- What is being tested?
- Self-questionnaires and semi-structured interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 5 Dec 2022to 17 May 2023
- How long will I take part?
- 6 Months
- 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: this study is proposed to adult women with metastatic HR+/HER2- breast cancer in first-line treatment
Who may be able to join
- Major woman
- Patient with metastatic breast cancer, either initially or secondary metastatic breast cancer
- RH+/HER2- tumor
- Patient starting first line metastatic therapy or currently undergoing 1st line metastatic treatment
- Patient diagnosed with metastatic breast cancer 6 months or more
- WHO 1 or 2 patient
- Postmenopausal or not
- Patient able to understand the French language
Who cannot join
- Patient WHO>2
- Patient undergoing chemotherapy
- HER2+ or triple negative tumor
- Male
- Patient diagnosed with breast cancer less than 6 months ago
- Patient under guardianship, curatorship or safeguard of justice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sexual Quality of Life and Metastatic Breast Cancer
The study is composed of three paper self-questionnaires to be filled in by the patients included at distance (> 6 months) from their diagnosis of metastatic breast cancer, in order to limit the impact of the announcement on the filling out the questionnaires.
After verification of the eligibility criteria, the medical oncologist will present the study to patients coming to the ICL for a follow-up consultation as part of their regular care. The patients will meet with a clinical research nurse so that she can explain the again and answer any questions they may have. She will also give the patients the questionnaires questionnaires and will give a presentation of the questions asked. After this meeting, the patients will be given sufficient time to reflect on, which may extend until their next visit to the ICL, in order to express, if they wish, their opposition to participating in the study. If she agrees to participate, the patient can then complete the questionnaires as well as the complementary questionnaire and place them in a closed envelope to be given to the clinical research nurse. The completion of the questionnaires will be completely anonymous. The data of those who object to the use of their data will be deleted from the database.
Read more
After the completion of the questionnaires, and in order to allow a benefit for the patient, a semi-directive interview in the form of a teleconsultation with a psycho-oncologist and sexologist will be offered. The interviews are not mandatory.
The time to fill in the self-questionnaires is estimated at 30 minutes and the semi-directive interview can last up to one hour. Finally, at the end of the study, as part of her subsequent care, each patient participating in the study will have the possibility to renew a teleconsultation with the psycho-oncologist and sexologist if she feels the need. As the subject of the study may generate personal questions and lead to a request for psychological and/or sexological care.
- Conditions
- Breast Cancer, Quality of Life, Sexual Behavior
- Being tested
- Self-questionnaires and semi-structured interview
- Medical subject headings
- Breast Neoplasms, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-questionnaires and semi-structured interviewBehavioural
Patients will fill these questionnaires : BISF-W, QLQ-C30, QLQ-BR23 and if they agree answer to a semi-structured interview composed of 5 questions
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Behavioral: Self-questionnaires and semi-structured interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of sexual quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment
Patients will fill the questionnaire : BISF-W (Brief Index of Sexual Function for Women)
Measured: Day 0
Secondary outcomes (3)
Assessment of overall quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment
Patients will fill the QLQ-C30 questionnaire
Measured: Day 0
Assessment of overall quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment
Patients will fill the QLQ+BR23 questionnaire
Measured: Day 0
Assessment of sexual and emotional intimacy
semi-structured interview composed of 5 questions
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start5 Dec 2022
- Primary completion17 May 2023
- Study completion17 May 2023
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.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- VINCENT MASSARD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577156
- Sponsor's protocol ID
- 2022-A01192-41
- Acronym
- SexoMBC2
- Status last verified
- Jul 2023
- First submitted
- 6 Oct 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sexual Quality of Life and Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT05577156
- Acronym / sponsor ID
- SexoMBC2 / 2022-A01192-41
- Conditions
- Breast Cancer, Quality of Life, Sexual Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 17 May 2023 (actual)
- Study completion
- 17 May 2023 (actual)
- First posted
- 13 Oct 2022 (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.
The study is composed of three paper self-questionnaires to be filled in by the patients included at distance (> 6 months) from their diagnosis of metastatic breast cancer, in order to limit the impact of the announcement on the filling out the questionnaires.
After verification of the eligibility criteria, the medical oncologist will present the study to patients coming to the ICL for a follow-up consultation as part of their regular care. The patients will meet with a clinical research nurse so that she can explain the again and answer any questions they may have. She will also give the patients the questionnaires questionnaires and will give a presentation of the questions asked. After this meeting, the patients will be given sufficient time to reflect on, which may extend until their next visit to the ICL, in order to express, if they wish, their opposition to participating in the study. If she agrees to participate, the patient can then complete the questionnaires as well as the complementary questionnaire and place them in a closed envelope to be given to the clinical research nurse. The completion of the questionnaires will be completely anonymous. The data of those who object to the use of their data will be deleted from the database.
After the completion of the questionnaires, and in order to allow a benefit for the patient, a semi-directive interview in the form of a teleconsultation with a psycho-oncologist and sexologist will be offered. The interviews are not mandatory.
The time to fill in the self-questionnaires is estimated at 30 minutes and the semi-directive interview can last up to one hour. Finally, at the end of the study, as part of her subsequent care, each patient participating in the study will have the possibility to renew a teleconsultation with the psycho-oncologist and sexologist if she feels the need. As the subject of the study may generate personal questions and lead to a request for psychological and/or sexological care.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Behavioral: Self-questionnaires and semi-structured interview |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- this study is proposed to adult women with metastatic HR+/HER2- breast cancer in first-line treatment
Key inclusion criteria (8 listed)
- Major woman
- Patient with metastatic breast cancer, either initially or secondary metastatic breast cancer
- RH+/HER2- tumor
- Patient starting first line metastatic therapy or currently undergoing 1st line metastatic treatment
- Patient diagnosed with metastatic breast cancer 6 months or more
Key exclusion criteria (6 listed)
- Patient WHO>2
- Patient undergoing chemotherapy
- HER2+ or triple negative tumor
- Male
- Patient diagnosed with breast cancer less than 6 months ago
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-questionnaires and semi-structured interviewPatients will fill these questionnaires : BISF-W, QLQ-C30, QLQ-BR23 and if they agree answer to a semi-structured interview composed of 5 questions | Behavioural | Patients |
Primary outcome
Assessment of sexual quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment
Time frame: Day 0
Patients will fill the questionnaire : BISF-W (Brief Index of Sexual Function for Women)
3 secondary outcomes
Assessment of overall quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment
Time frame: Day 0
Assessment of overall quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment
Time frame: Day 0
Assessment of sexual and emotional intimacy
Time frame: Day 0
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 28 Jul 2023.
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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.
VINCENT MASSARD principal investigator
Institut de Cancérologie de Lorraine
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 Quality of Life, run by Institut de Cancérologie de Lorraine 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 6 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 28 Jul 2023. 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?
Assessment of sexual quality of life in women with HR+/HER2- metastatic breast cancer in first-line treatment (time frame: Day 0). 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 28 Jul 2023.