Quality of Life and Breast Cancer in Older Women
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 174
- 试验地点
- 2
- 主要终点
- Evaluation of quality of life change by SF-36 (The Short Form Health Survey) between baseline and six months
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 100 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Elderly patients about or over 75 years
- •Patients in whom a diagnosis of breast cancer with surgical indication for mastectomy with or without lymph node dissection is discussed
- •Ability to understand and give freely consent
- •Informed consent signed
- •Patient affiliated to the social security or entitled
排除标准
- •Patients under 75 years
- •Patients under legal protection
研究组 & 干预措施
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.
干预措施: Determination of acceptance and / or rejection of mastectomy (Other)
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.
干预措施: Determination of acceptance and / or rejection of mastectomy (Other)
结局指标
主要结局
Evaluation of quality of life change by SF-36 (The Short Form Health Survey) between baseline and six months
时间窗: Baseline and 6 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
次要结局
- Psychological profile(Baseline and 6 months)
- QLQ-C30 (Global Health Status)(Baseline and 6 months)