Effect of Early Palliative Care on Quality of Life of Patients With Advanced Cancer: a Randomised Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- Quality of life of the patient and his family caregiver at 12 weeks.
研究概览
简要总结
The World Health Organization (WHO) defines palliative care as an approach to improve the quality of life of patients and their families facing life-threatening illness, through prevention and relief of pain and of physical, psychosocial and spiritual problems. The WHO stresses that palliative care is applicable early in the course of the illness together with other therapies that are intended to cure or prolong life, such as chemotherapy or radiation therapy. For the benefit of the patient, palliative care is however often given (too) late in the course of the disease of incurably ill patients.
The aim of our study is to measure the effect of interventional palliative care on quality of life, mood and end-of-life care of patients with advanced cancer and their families. These patients have a limited life expectancy and a high symptom burden, this leads us to suggest that these patients may be benefited with palliative care soon after diagnosis of metastatic disease (interventional palliative care).
The research design of this study is a randomized controlled trial with, on the one hand, an intervention group in which patients and their families receive interventional palliative care in combination with standard cancer care and on the other hand a control group in which patients and their families receive only standard oncologic care. Participants in the intervention group will meet the palliative support team shortly after diagnosis. Afterwards, the palliative support will meet them at least once a month. This intervention focuses on topics such illness understanding, symptom management, decision making and coping with the disease. Participants in the control group will only meet with the palliative support team at the patient's own request or after referral by the oncologist or the nursing staff.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Patients with life-limiting cancer (prognosis of approximately 1 year) are eligible if:
- •Patients are within 12 weeks of referral from an other hospital after receiving first line treatment or within 8 to 12 weeks of a new diagnosis (histological and cytological confirmed):
- •Metastatic and advanced pancreatic, stomach, oesophageal and biliary tract adenocarcinoma;
- •Metastatic or advanced NSCLC (stage IIIB or IV) or metastatic SCLC,
- •Malignant pleural mesothelioma
- •Metastatic or advanced head and neck cancer (stage III or IV)
- •Patients are within 12 weeks of progression after receiving treatment and have an prognosis of approximately 1 year:
- •Metastatic and locally advanced colorectal cancer, with progression after second line treatment
- •Metastatic or advanced prostate carcinoma, after second line treatment
- •Advanced breast cancer with visceral and/or brain metastasis, with progression on second or third line treatment
- •Metastatic melanoma,
- •Metastatic or advanced kidney cancer,
- •Metastatic or advanced bladder cancer after first line treatment,
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 and ability to read and respond to questions in Dutch.
- •Exclusion criteria:
- •Patients under 18 years old
- •Patients with impaired cognition
- •Patients who met the palliative support team more then once or had a consultation within 6 months of inclusion.
排除标准
- 未提供
结局指标
主要结局
Quality of life of the patient and his family caregiver at 12 weeks.
时间窗: at 12 weeks
This will be measured with validated questionnaires (EORTC-QLQ C30, McGill QoL, SF-36).
Quality of life of the patient and his family caregiver, 6-weekly after 12 weeks.
时间窗: 6-weekly after 12 weeks
This will be measured with validated questionnaires (EORTC-QLQ C30, McGill QoL, SF-36).
Quality of life of the patient and his family caregiver at baseline.
时间窗: at baseline
This will be measured with validated questionnaires(EORTC-QLQ C30, McGill QoL, SF-36).
次要结局
- Influence of palliative care on mood and illness-understanding of patients and family caregivers at baseline.(at baseline.)
- Influence of palliative care on the decision of physicians with regards to end-of-life-care.(after death of patient)
- Influence of palliative care on mood and illness-understanding of patients and family caregivers 6-weekly, after 12 weeks.(6-weekly, after 12 weeks.)
- Influence of palliative care on mood and illness-understanding of patients and family caregivers at 12 weeks.(at 12 weeks)