Clinical Trials Directory

Trials / Unknown

UnknownNCT04038606

SEINIOR:Quality of Life and Breast Cancer in Older Women

Quality of Life and Breast Cancer in Older Women

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
174 (estimated)
Sponsor
Central Hospital Saint Quentin · Other Government
Sex
Female
Age
75 Years – 100 Years
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
OTHERDetermination 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.:-)

Timeline

Start date
2016-12-15
Primary completion
2020-12-15
Completion
2020-12-15
First posted
2019-07-31
Last updated
2019-07-31

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04038606. Inclusion in this directory is not an endorsement.