The Impact of Palliative Care on Quality of Life, Anxiety, and Depression in Patients With Idiopathic Pulmonary Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change from baseline respiratory quality of life as measured by SGRQ
研究概览
简要总结
The purpose of this study is to evaluate the effects of adding a palliative care intervention for patients with idiopathic pulmonary fibrosis (IPF) to current standard of care.
Palliative care is comprehensive, coordinated interdisciplinary care for patients and families facing a potentially life-threatening illness. This consists of specially trained teams of professionals including physicians, nurses, social workers, and chaplains that provide care and support in inpatient and outpatient settings. While the specific assistance and support provided by the Palliative Care Service depends on individual patient and family needs and preferences, it may include:
- Pain and symptom management
- Psychosocial and spiritual support
- Assistance with treatment choices
- Help in planning for care in the community
详细描述
Idiopathic pulmonary fibrosis (IPF) is a progressive and heterogeneous fibrotic lung disease. It is universally fatal, with an average time to death between two to five years.
Patients with IPF experience significantly diminished quality of life and increased symptom burden. Besides dyspnea, cough, fatigue, and deconditioning, patients with IPF experience significant depression and anxiety. The benefit of palliative care has been demonstrated in several other diseases, notably, in metastatic lung cancer. Patients with metastatic lung cancer who were seen by palliative care at the time of their diagnosis and throughout their disease course were found to have increased survival, improved quality of life, and received less aggressive care at the end of their life. This finding has prompted significant research in the role of palliative care in other diseases, including chronic lung disease. A non-blinded, randomized trial of a multi-disciplinary breathlessness service intervention in patients with advanced disease including cancer, chronic obstructive lung disease (COPD), interstitial lung disease (ILD), and congestive heart failure demonstrated improvement in breathlessness, anxiety, and even survival. Specific Aim 1: Determine if quality of life is improved with a palliative care intervention. Specific Aim 2: Determine if depression and anxiety symptoms are decreased with a palliative care intervention. Secondary aims include an examination of pulmonary function tests (PFT), number of hospitalizations, and overall mortality as an effect of a palliative care intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IPF as diagnosed by chest CT or lung biopsy, and documented by a pulmonologist in the patient's medical record
- •Capacity to provide informed consent
排除标准
- •Documented malignancy that would impact mortality within the study enrollment period
- •Inability to pay for palliative care visit, insurance or personally.
结局指标
主要结局
Change from baseline respiratory quality of life as measured by SGRQ
时间窗: 6 months
The Saint George's Respiratory Questionnaire (SGRQ) is 50-item survey with scores ranging from 0 to 100 and with higher scores indicating worse quality of life.
Change from baseline anxiety and depression symptoms as measured by HADS
时间窗: 6 months
The Hospital Depression and Anxiety Index (HADS) is a 14-item survey with scores ranging from 0 to 21 and with higher scores indicating greater depression and anxiety.
Change in prevalence of baseline depression as measured by PHQ-9
时间窗: 6 months
The Patient Health Questionnaire (PHQ-9) is a 10-item survey with scores ranging from 1 to 27 and with higher scores indicating greater levels of depression.
次要结局
- Change from baseline of diffusing capacity(6 months)
- All-cause mortality(6 months)
- Change from baseline of lung volume(6 months)
- Change from baseline of 6-minute walk distance(6 months)
- Change from baseline of spirometry(6 months)
- Total number of hospitalizations due to any cause(6 months)