SEINIOR:Quality of Life and Breast Cancer in Older Women
NCT ID: NCT04038606
Last Updated: 2019-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
174 participants
INTERVENTIONAL
2016-12-15
2020-12-15
Brief Summary
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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
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
Participants will undergo blood test, electrocardiogram, blood pressure monitoring, geriatric standard evaluation.
DIAGNOSTIC
NONE
Study Groups
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acceptance of mastectomy
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.
Determination of acceptance and / or rejection of mastectomy
Blood exams,Participants completed a questionnaire translated in French language : Rosenberg,SF-36, QLQC30, Big Five Inventory,BPI-SF.:-)
rejection of mastectomy
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.
Determination of acceptance and / or rejection of mastectomy
Blood exams,Participants completed a questionnaire translated in French language : Rosenberg,SF-36, QLQC30, Big Five Inventory,BPI-SF.:-)
Interventions
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Determination of acceptance and / or rejection of mastectomy
Blood exams,Participants completed a questionnaire translated in French language : Rosenberg,SF-36, QLQC30, Big Five Inventory,BPI-SF.:-)
Eligibility Criteria
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Inclusion Criteria
2. Female
3. Patients in whom a diagnosis of breast cancer with surgical indication for mastectomy with or without lymph node dissection is discussed
4. Ability to understand and give freely consent
5. Informed consent signed
6. Patient affiliated to the social security or entitled
Exclusion Criteria
2. Male
3. Patients under legal protection
75 Years
100 Years
FEMALE
No
Sponsors
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Central Hospital Saint Quentin
OTHER_GOV
Responsible Party
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Principal Investigators
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ATTIER-ZMUDKA Dr Jadwiga, PI
Role: PRINCIPAL_INVESTIGATOR
Saint Quentin Hospital
Locations
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Centre Hospitalier de Saint-Quentin;
Saint-Quentin, Aisne, France
Countries
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Central Contacts
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Facility Contacts
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ATTIER Dr Jadwiga, PI
Role: primary
Other Identifiers
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2016-A00286-45
Identifier Type: -
Identifier Source: org_study_id