Clinical trial NCT04038606: SEINIOR:Quality of Life and Breast Cancer in Older Women
Official title: Quality of Life and Breast Cancer in Older Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Central Hospital Saint Quentin
Sponsor class: OTHER_GOV
First posted: 2019-07-31
Enrollment: 174
Sex: FEMALE
Minimum age (years): 75
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of quality of life change by SF-36 (The Short Form Health Survey) between baseline and six months
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: QLQ-C30 (Global Health Status)
timeFrame: Baseline and 6 months
measure: Psychological profile
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Saint-Quentin
country: France
facility: Centre Hospitalier de Saint-Quentin;
state: Aisne
Study officials:
affiliation: Saint Quentin Hospital
name: ATTIER-ZMUDKA Dr Jadwiga, PI
role: PRINCIPAL_INVESTIGATOR
References: