GEriatric Determinants of Curative RAdiotherapy Scheme Choice for Breast Cancer ELderly Patient Treatment Compliance and Tolerance : GERABEL Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 241
- 试验地点
- 6
- 主要终点
- Measure of the tolerance
研究概览
简要总结
This study proposes an onco geriatric evaluation (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests) for elderly breast cancer patients. The score obtained at this evaluation will determine the radiotherapy scheme.
详细描述
Breast cancer is the most frequent cancer for elderly women and represents the first mortality cause for them. Breast cancer incidence increases for elderly women and will become a major public health problem in the next years.
The principal therapeutic solution is the partial mastectomy associated to radiotherapy. However, the radiotherapy scheme and its role are debated for elderly patients. Hypo fractionated radiotherapy could be considered as an advantageous option.
The treatment duration (6,5 weeks) and direct and indirect fatigue (around 33 travels) are major cons. Thereby, for elderly patients, the selection of patients who will benefit from a shorter treatment could be really difficult. It would be interesting to define an objective scoring, predicting a bad or good tolerance and observance to the radiotherapy. Nowadays, onco geriatric evaluations are used to decide some treatment's decision, but no study compared different orientated radiotherapy schemes.
The present study proposes an onco geriatric evaluation leading to a score according to seven tests (Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and " timed get up and go " tests). The score will then determine an adapted radiotherapy scheme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman more than 70 years old,
- •Patient carrying a breast cancer proven histologically and treated by radiotherapy in curative intent.
排除标准
- •Patient with metastatic cancer,
- •Patient with impossible follow-up at 6 months (planned relocation, patient support in another Center),
- •Patient under protection of justice or unable to give consent.
结局指标
主要结局
Measure of the tolerance
时间窗: Month 6
Tolerance is considered as " bad " if the score of the onco geriatric evaluation decreases of more than 20% from the initial evaluation to 6 months after the end of the rays. Tolerance is considered as "correct" in the other cases.
次要结局
- Quality of Life Questionnaire(Month 6)
- Correlation between tolerance and the number of concomitant treatments(Month 6)
- Tolerance(Month 6)
- Radiotherapy compliance(Month 6)
- Correlation between tolerance and distance from the therapeutic center(Month 6)
- Correlation between tolerance and way of transport(Month 6)
- Correlation between tolerance and the nature of concomitant treatments(Month 6)
- Correlation between tolerance and the supportive cares(Month 6)