SEINIOR:Quality of Life and Breast Cancer in Older Women

Breast Cancer Clinical Trial

— SEINIOR  

Official title:

Quality of Life and Breast Cancer in Older Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04038606
• Other study ID #: 2016-A00286-45
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2016
• Est. completion date: December 15, 2020

Study information

• Verified date: March 2019
• Source: Central Hospital Saint Quentin
• Contact: ATTIER-ZMUDKA Dr Jadwiga, IC
• Phone: 00333 23 06 72 16
• Email: J.ATTIER[@]ch-stquentin.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 75 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• 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.:-)

Locations

Country	Name	City	State
France	Centre Hospitalier de Saint-Quentin;	Saint-Quentin	Aisne

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital Saint Quentin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 6 months
Secondary	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.	Baseline and 6 months
Secondary	Psychological profile	Big Five Inventory (BFI),personality inventory for research settings, minimum = 45 points and maximum scores = 180 points .	Baseline and 6 months