Effect of Palliative Care in Patients With End Stage Pulmonary Fibrosis: a Randomized Control Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- depression
研究概览
简要总结
The investigators will examine the effect of introducing palliative in patients with end-stage idiopathic pulmonary fibrosis, refractory to the pharmacological treatment or not deemed to be treated, on patient-reported outcomes and end-of-life care. The investigators will randomly assign patients who receive either early palliative care integrated with standard respiratory care or standard respiratory care alone.
Quality of life and symptoms will assessed at baseline and at 12 weeks The primary outcome will be the change in the quality of life and symptoms at 12 months.
详细描述
Advanced fibrosing interstitial lung disease (ILD) is a group of often progressive and incurable conditions.
The most common form of ILD, idiopathic pulmonary fibrosis (IPF), is associated with poor survival, and high symptom burden and poor quality of life as the disease progresses.
ILD represents an increasing proportion of patients with chronic hypoxemic respiratory failure.
Despite this poor prognosis, palliative care remains underused in patients with ILD. This may be due to under-recognition of the palliative care needs and symptom burden, or unfamiliarity and discomfort with palliative therapies.
Though oncology has largely embraced earlier integration of palliative care, which has translated into improvements in end-of-life (EOL) care for patients with lung cancer,palliative and EOL care for non-malignant diseases are now gaining increased attention.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of idiophatic pulmonary fibrosis
- •resting partial arterial oxygen pressure (PaO2) < 60 mmHg
- •Decline in Forced Vital Capacity (FVC) > 10% in the last 6 months
- •stage 3 according to the GAP index
排除标准
- •active treatment with antifibrotic drug
- •concomitant cancer
结局指标
主要结局
depression
时间窗: 12 months
Center for Epidemiologic Studies Depression score (C-ESDs)
clinical status and quality of life
时间窗: 12 months
Maugeri Respiratory Questionnaire reduced form
dyspnea score
时间窗: 12 months
Borg scale
次要结局
- survival(12 months)
研究者
dr. Stefano Nava
Professor of Respiratory Medicine
IRCCS Azienda Ospedaliero-Universitaria di Bologna