Breast CancerSEINIORNCT04038606
SEINIOR:Quality of Life and Breast Cancer in Older Women
A study testing Determination of acceptance and / or rejection of mastectomy in people with Breast Cancer, run by Central Hospital Saint Quentin at 1 site in France.
Trial summary
Background : Breast cancer is a disease that occurs primarily in elderly women: 54057 of breast cancer occurred on women in 2008, 15.2% were between 75 and 84 years and 5.4% were over 85 years. Read more about this study
- Who is it for?
- Ages 75 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Determination of acceptance and / or rejection of mastectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2016to 15 Dec 2020
- Phase
- Interventional
- 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 75 to 100 years
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Elderly patients about or over 75 years
- Female
- Patients in whom a diagnosis of breast cancer with surgical indication for mastectomy with or without lymph node dissection is discussed
- Ability to understand and give freely consent
- Informed consent signed
- Patient affiliated to the social security or entitled
Who cannot join
- Patients under 75 years
- Male
- Patients under legal protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de Saint-Quentin;
Saint-Quentin, Aisne, 02100
ATTIER Dr Jadwiga, PI
About this study
Official title: Quality of Life and Breast Cancer in Older Women
Background :
Breast cancer is a disease that occurs primarily in elderly women: 54057 of breast cancer occurred on women in 2008, 15.2% were between 75 and 84 years and 5.4% were over 85 years. Elderly women cancers care exposes to several problems: the opportunity for screening, knowing that mammography is not recommended after 75 years old, and the level of treatment depending on the background and the existence of weaknesses. It should determine whether patients are in adequate physiological condition to tolerate classical and "complete" treatment or conversely in a precarious state with advanced fragility, justifying only lightened and adapted symptomatic treatment.
Read more
Purpose :
The purpose of this research theme is to assess the quality of life of elderly patients who underwent mastectomy for breast cancer. The objectives are:
- Assess the determinants of acceptance and / or rejection of mastectomy based on personal background (level of fragility, self-image) and linked to cancer
- Assess the quality of life, 6 months later, of women who underwent or not mastectomy, and appreciate the determinants
Abstract :
The total mastectomy allow, oncologically, a more valid treatment than a lumpectomy, in many cases of women suffering from a breast cancer, but its relevance and acceptability are poorly known. Some think that an elderly woman, postmenopausal, is less concerned with her aesthetics and feminine attributes, which would allow her to accept easily the mastectomy.
The research hypothesis is that the acceptability of mastectomy is not good in elderly women
Read the detailed description
Primary outcome:
Better detection of comorbidity and geriatric syndromes in vulnerable patients Better detection of a degradation of the quality of life at D0 (at diagnosis)
Secondary outcomes:
Better support for quality of life and psychological support after mastectomy (revaluation to 6 months) Integration of patients in the geriatric sector and implementation of regular monitoring Study design: prospective, multicenter
- Conditions
- Breast Cancer
- Being tested
- Determination of acceptance and / or rejection of mastectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determination of acceptance and / or rejection of mastectomyOther
Blood exams,Participants completed a questionnaire translated in French language : Rosenberg,SF-36, QLQC30, Big Five Inventory,BPI-SF.:-)
| Study group | Role | What they receive |
|---|---|---|
| acceptance of mastectomy | Active comparator | Assess the determinants of acceptance of mastectomy based on personal background,Measured by questionnaires: self-image (Rosenberg),personal background (level of fragility, self-image),quality of life SF-36, QLQC30,pain (BPI-SF) and Big Five Inventory. Receives: Other: Determination of acceptance and / or rejection of mastectomy |
| rejection of mastectomy | Experimental | Assess the determinants of rejection of mastectomy based on personal background, Measured by questionnaires: self-image (Rosenberg),personal background (level of fragility, self-image),quality of life SF-36, QLQC30,pain (BPI-SF) and Big Five Inventory. Receives: Other: Determination of acceptance and / or rejection of mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of quality of life change by SF-36 (The Short Form Health Survey) between baseline and six months
the 36-Item Short Form Health Survey (SF-36). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized monitoring and assessment of care outcomes in adult patients.
a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
Measured: Baseline and 6 months
Secondary outcomes (2)
QLQ-C30 (Global Health Status)
Quality of life (QoL or QOL) is the perceived quality of an individual's daily life, that is, an assessment of their well-being or lack thereof. This includes all emotional, social and physical aspects of the individual's life;All of the scales and single-item measures range in score from 0 to 100.
Measured: Baseline and 6 months
Psychological profile
Big Five Inventory (BFI),personality inventory for research settings, minimum = 45 points and maximum scores = 180 points .
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start15 Dec 2016
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Dec 2020 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants completed a questionnaires that included the test sociodemographic characteristics and a number of standardized validated instruments translated in French language designed to assess for quality of life and psychological profile. Participants will undergo blood test, electrocardiogram, blood pressure monitoring, geriatric standard evaluation.
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital Saint Quentin
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- ATTIER-ZMUDKA Dr Jadwiga, PI, Principal investigator, Saint Quentin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04038606
- Sponsor's protocol ID
- 2016-A00286-45
- Acronym
- SEINIOR
- Status last verified
- Mar 2019
- First submitted
- 28 Sep 2016
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participants completed a questionnaire that included the test sociodemographic characteristics and a number of standardized validated instruments translated in French language designed to assess for quality of life and psychological profile. Participants will undergo blood test, electrocardiogram, blood pressure monitoring, geriatric standard evaluation.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Breast Cancer in Older Women
- ClinicalTrials.gov ID
- NCT04038606
- Acronym / sponsor ID
- SEINIOR / 2016-A00286-45
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Central Hospital Saint QuentinOther government
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Dec 2020 (estimated)
- First posted
- 31 Jul 2019 (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.
Background :
Breast cancer is a disease that occurs primarily in elderly women: 54057 of breast cancer occurred on women in 2008, 15.2% were between 75 and 84 years and 5.4% were over 85 years. Elderly women cancers care exposes to several problems: the opportunity for screening, knowing that mammography is not recommended after 75 years old, and the level of treatment depending on the background and the existence of weaknesses. It should determine whether patients are in adequate physiological condition to tolerate classical and "complete" treatment or conversely in a precarious state with advanced fragility, justifying only lightened and adapted symptomatic treatment.
Purpose :
The purpose of this research theme is to assess the quality of life of elderly patients who underwent mastectomy for breast cancer. The objectives are:
- Assess the determinants of acceptance and / or rejection of mastectomy based on personal background (level of fragility, self-image) and linked to cancer
- Assess the quality of life, 6 months later, of women who underwent or not mastectomy, and appreciate the determinants
Abstract :
The total mastectomy allow, oncologically, a more valid treatment than a lumpectomy, in many cases of women suffering from a breast cancer, but its relevance and acceptability are poorly known. Some think that an elderly woman, postmenopausal, is less concerned with her aesthetics and feminine attributes, which would allow her to accept easily the mastectomy.
The research hypothesis is that the acceptability of mastectomy is not good in elderly women
Detailed description
Primary outcome:
Better detection of comorbidity and geriatric syndromes in vulnerable patients Better detection of a degradation of the quality of life at D0 (at diagnosis)
Secondary outcomes:
Better support for quality of life and psychological support after mastectomy (revaluation to 6 months) Integration of patients in the geriatric sector and implementation of regular monitoring Study design: prospective, multicenter
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants completed a questionnaires that included the test sociodemographic characteristics and a number of standardized validated instruments translated in French language designed to assess for quality of life and psychological profile. Participants will undergo blood test, electrocardiogram, blood pressure monitoring, geriatric standard evaluation.
| Arm | Type | Receives |
|---|---|---|
| acceptance of mastectomy | Active comparator | Other: Determination of acceptance and / or rejection of mastectomyAssess the determinants of acceptance of mastectomy based on personal background,Measured by questionnaires: self-image (Rosenberg),personal background (level of fragility, self-image),quality of life SF-36, QLQC30,pain (BPI-SF) and Big Five Inventory. |
| rejection of mastectomy | Experimental | Other: Determination of acceptance and / or rejection of mastectomyAssess the determinants of rejection of mastectomy based on personal background, Measured by questionnaires: self-image (Rosenberg),personal background (level of fragility, self-image),quality of life SF-36, QLQC30,pain (BPI-SF) and Big Five Inventory. |
Who may qualify
- Ages
- 75 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Elderly patients about or over 75 years
- Female
- Patients in whom a diagnosis of breast cancer with surgical indication for mastectomy with or without lymph node dissection is discussed
- Ability to understand and give freely consent
- Informed consent signed
Key exclusion criteria (3 listed)
- Patients under 75 years
- Male
- Patients under legal protection
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 |
|---|---|---|
| Determination of acceptance and / or rejection of mastectomyBlood exams,Participants completed a questionnaire translated in French language : Rosenberg,SF-36, QLQC30, Big Five Inventory,BPI-SF.:-) | Other | acceptance of mastectomy, rejection of mastectomy |
Primary outcome
Evaluation of quality of life change by SF-36 (The Short Form Health Survey) between baseline and six months
Time frame: Baseline and 6 months
the 36-Item Short Form Health Survey (SF-36). SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and are now widely utilized monitoring and assessment of care outcomes in adult patients. a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability
2 secondary outcomes
QLQ-C30 (Global Health Status)
Time frame: Baseline and 6 months
Psychological profile
Time frame: Baseline and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: No. Participants completed a questionnaire that included the test sociodemographic characteristics and a number of standardized validated instruments translated in French language designed to assess for quality of life and psychological profile. Participants will undergo blood test, electrocardiogram, blood pressure monitoring, geriatric standard evaluation.
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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.
ATTIER-ZMUDKA Dr Jadwiga, PI principal investigator
Saint Quentin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Determination of acceptance and / or rejection of mastectomy in people with Breast Cancer, run by Central Hospital Saint Quentin 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 6 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: status not confirmed, as of the sponsor's last update on 31 Jul 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ATTIER-ZMUDKA Dr Jadwiga, IC (00333 23 06 72 16, J.ATTIER@ch-stquentin.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of quality of life change by SF-36 (The Short Form Health Survey) between baseline and six months (time frame: Baseline and 6 months). 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 31 Jul 2019.