Optimization of Care in Older Patients With Cancer Undergoing Treatment in Day Care Unit, Through a Specific Management Based on Early Geriatric Warning Signs: a Multicenter Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,010
- 主要终点
- Proportion of patients with unchanged or improved global quality of life between M0 and M6.
研究概览
简要总结
The WARNING project proposes a new care organisation for older patients with cancer. The aim is to optimise management in daycare with early detection signs of geriatric syndromes and specific interventions. This prevention package, called the 'WARNING Pack', includes a specific multimodal geriatric management guide for the oncologist (physician form), based on patient-reported early geriatric warning signs (patient form). Primary outcome is to reduce the risk of deterioration in global quality of life at 6 months during treatment and to prevent the onset of geriatric syndromes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥75 years.
- •Patients with confirmed solid cancer or haematological malignancy, regardless of
- •the site of the tumour (single or multiple), - the duration of the disease, or - the treatment modality (adjuvant, neoadjuvant, locally advanced, palliative metastatic).
- •Patients starting a first line of systemic treatment or a new line of treatment after a break of at least six months.
- •Patients treated in a daycare hospital.
- •Persons belonging to or benefiting from a social security scheme.
- •Free and informed consent after receiving appropriate information.
排除标准
- •Patients under legal protection (guardianship, curatorship).
- •Persons with enhanced protection, i.e. persons deprived of their liberty by a judicial or administrative decision, persons in a health or social care institution, persons under legal protection and patients in emergency situations.
研究组 & 干预措施
the experimental group, the WARNING pack
the WARNING pack + routine care
干预措施: WARNING Pack (Other)
Standard group
routine care
结局指标
主要结局
Proportion of patients with unchanged or improved global quality of life between M0 and M6.
时间窗: 6 month
次要结局
未报告次要终点