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SEINIOR:Quality of Life and Breast Cancer in Older Women

Quality of Life and Breast Cancer in Older Women

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04038606
Acronym
SEINIOR
Enrollment
174
Registered
2019-07-31
Start date
2016-12-15
Completion date
2020-12-15
Last updated
2019-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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. 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

Interventions

OTHERDetermination 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.:-)

Sponsors

Central Hospital Saint Quentin
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
75 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. Elderly patients about or over 75 years 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

1. Patients under 75 years 2. Male 3. Patients under legal protection

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of quality of life change by SF-36 (The Short Form Health Survey) between baseline and six monthsBaseline and 6 monthsthe 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

Secondary

MeasureTime frameDescription
QLQ-C30 (Global Health Status)Baseline and 6 monthsQuality 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.
Psychological profileBaseline and 6 monthsBig Five Inventory (BFI),personality inventory for research settings, minimum = 45 points and maximum scores = 180 points .

Countries

France

Contacts

Primary ContactATTIER-ZMUDKA Dr Jadwiga, IC
J.ATTIER@ch-stquentin.fr00333 23 06 72 16
Backup ContactBOULANOUAR M Abdelkrim, CRA
AK.BOULANOUAR@ch-stquentin.fr0033323067861

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026