Metastatic Breast CarcinomaSexoMBCNCT03408769
Metastatic Breast Carcinoma and Women Sexual Quality of Life
An observational study of Metastatic Breast Carcinoma, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial summary
Sexual health is one of the relevant parameters for assesing the quality of life. Improvement sexual and emotional function improves quality of life scores and depression or anxiety in curative phase. Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Metastatic Breast Carcinoma
- What is being tested?
- Medical questionnaire
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 12 Mar 2018to 4 Apr 2018
- 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 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study will be offered to women aged 50 to 70, with metastatic breast carcinoma and living in a couple and followed at the Lorraine Institute of Oncology.
Who may be able to join
- Women with metastatic breast cancer
- Age ≥ 50 and < 70 years old
- Diagnosis of metastatic breast cancer at least 6 months prior to study participation
- Patient living with a partner
- Menopausal women (absence of menstruation for 1 year minimum)
- ECOG performance status ≤ 2
- Affiliated to public health system
- Informed and having expressed her non-opposition
Who cannot join
- Patient in exclusive palliative care
- Single or not living in a couple
- Non-menopausal patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life
Sexual health is one of the relevant parameters for assesing the quality of life.
Improvement sexual and emotional function improves quality of life scores and depression or anxiety in curative phase.
The purpose of the study is to assess the quality of sexual life of postmenopausal women with metastatic breast cancer in couples and to establish links with overall quality of life and the quality of the relationship.
Read the detailed description
We use a quantitative methodology to assess quality of female sexual life, quality of life and quality o relationship with validated scientific questionnaires.
The sexual and emotional intimacy will be explored by semi structured interview, not mandatory for patients.
- Conditions
- Metastatic Breast Carcinoma
- Being tested
- Medical questionnaire
- Keywords
- Cancer, Sexuality, Quality of life, Intimacy, BISF-WBrief Index of Sexual Functioning for Women questionnaire, Quality of life questionnaire (EORTC QLQ-BR23):, Partnership questionnaire (partnerschaftsfragebogen; PFB)
- Medical subject headings
- Breast Neoplasms, Neoplasms, Sexuality, pseudofolliculitis barbae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical questionnaireOther
- Brief Index of Sexual Functioning for Women questionnaire
- Quality of life questionnaire (EORTC QLQ-BR23)
- Partnership questionnaire (partnerschaftsfragebogen; PFB)
- Short interview about their sexual intimacy
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of sexual life of postmenopausal women with metastatic breast carcinoma living in couples
Quality of sexual life will assessed by BISF-W (Brief index of sexual functioning for women) questionnaire
Measured: 1 day
Secondary outcomes (3)
Quality of life
Quality of life will assessed by quality of life breast cancer module questionnaire (QLQ-BR23) (Hinz et al, 2014)
Measured: 1 day
Quality of Relationship of the couple
Quality of Relationship of the couple will assessed by partnership questionnaire (PFB). 30 items making up a global scale measuring the Quality of relationship (PFB).Quality of relationship (PFB) score can be obtained with the following equation: PFB = (30 - Quarreling) + Tenderness + Togetherness/communication ( Rossier et al, 2006).
Measured: 1 day
Sexual and emotional intimacy
Patients will be interviewed by open-ended questions face to face concerning their Sexual and emotional intimacy.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start12 Mar 2018
- Primary completion4 Apr 2018
- Study completion4 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CarcinomaStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dubuc Myriam, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03408769
- Sponsor's protocol ID
- 2017-A03413-50
- Acronym
- SexoMBC
- Status last verified
- Aug 2018
- First submitted
- 18 Jan 2018
- Last updated
- 8 Aug 2018
- 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 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metastatic Breast Carcinoma: Evaluation of Women Sexual Quality of Life
- ClinicalTrials.gov ID
- NCT03408769
- Acronym / sponsor ID
- SexoMBC / 2017-A03413-50
- Conditions
- Metastatic Breast Carcinoma
- Keywords
- Cancer, Sexuality, Quality of life, Intimacy, BISF-WBrief Index of Sexual Functioning for Women questionnaire, Quality of life questionnaire (EORTC QLQ-BR23):, Partnership questionnaire (partnerschaftsfragebogen; PFB)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 4 Apr 2018 (actual)
- First posted
- 24 Jan 2018 (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.
Sexual health is one of the relevant parameters for assesing the quality of life.
Improvement sexual and emotional function improves quality of life scores and depression or anxiety in curative phase.
The purpose of the study is to assess the quality of sexual life of postmenopausal women with metastatic breast cancer in couples and to establish links with overall quality of life and the quality of the relationship.
Detailed description
We use a quantitative methodology to assess quality of female sexual life, quality of life and quality o relationship with validated scientific questionnaires.
The sexual and emotional intimacy will be explored by semi structured interview, not mandatory for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be offered to women aged 50 to 70, with metastatic breast carcinoma and living in a couple and followed at the Lorraine Institute of Oncology.
Key inclusion criteria (8 listed)
- Women with metastatic breast cancer
- Age ≥ 50 and < 70 years old
- Diagnosis of metastatic breast cancer at least 6 months prior to study participation
- Patient living with a partner
- Menopausal women (absence of menstruation for 1 year minimum)
Key exclusion criteria (3 listed)
- Patient in exclusive palliative care
- Single or not living in a couple
- Non-menopausal patient
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 |
|---|---|---|
| Medical questionnaire* Brief Index of Sexual Functioning for Women questionnaire * Quality of life questionnaire (EORTC QLQ-BR23) * Partnership questionnaire (partnerschaftsfragebogen; PFB) * Short interview about their sexual intimacy | Other | – |
Primary outcome
Quality of sexual life of postmenopausal women with metastatic breast carcinoma living in couples
Time frame: 1 day
Quality of sexual life will assessed by BISF-W (Brief index of sexual functioning for women) questionnaire
3 secondary outcomes
Quality of life
Time frame: 1 day
Quality of Relationship of the couple
Time frame: 1 day
Sexual and emotional intimacy
Time frame: 1 day
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 8 Aug 2018.
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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.
Dubuc Myriam 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 Metastatic Breast Carcinoma, 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 3 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 8 Aug 2018. 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?
Quality of sexual life of postmenopausal women with metastatic breast carcinoma living in couples (time frame: 1 day). 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 8 Aug 2018.