Danish Palliative Care Trial (DanPaCT): A Randomised Clinical Multi-centre Trial Investigating the Effect of Specialised Palliative Care on Symptoms, Survival, Economical Factors and Satisfaction in Patients With Cancer Reporting Palliative Needs
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 12
- 主要终点
- Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need
研究概览
简要总结
Specialised palliative care (SPC) seeks to relieve suffering and improve quality of life in patients with a life threatening disease such as advanced cancer. Many patients with advanced cancer are not in contact with SPC. Previous studies have shown that among advanced cancer patients not referred to SPC there is a significant prevalence of symptoms, problems and needs. The aims of the present study are to investigate whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to SPC and to investigate the economical consequences of such a referral.
详细描述
The trial is a randomised, clinical, multicenter trial including 6 Danish SPC-centres. The basic principle is that patients with palliative needs (see inclusion criteria) are identified at oncological departments and randomised to either (i) standard treatment plus SPC (intervention group) or (ii) standard treatment (control group).
Patients will be identified by the following procedure: A) Each week a research nurse reviews the medical records of consecutive patients seen in oncological out-patients clinic. B) Eligible patients are asked to fill out a questionnaire (the screening) that investigates symptoms and problems. The patients are told that their questionnaire will be evaluated and that the research nurse will contact some of the patients later on with information about a RCT. C) Those patients who report at least one palliative need in the questionnaire (see inclusion criteria) and have four additional symptoms are contacted by the research nurse who provide the patients with written and verbal information about the RCT. D) Patients who give informed consent are randomised.
Detailed statistical analysis plan:
Analysis of the primary outcome The primary outcome analysis will be a modified ITT analysis. Patients who withdrew consent after randomisation, who were randomised by mistake and did not fulfil our inclusion criteria, or who were not alive at the time of the follow-ups, will be excluded from the primary analysis. All exclusions will be shown in the CONSORT flow-chart of patient participation.
In the primary outcome analysis we will use multiple imputation for non-responders if there are more than 5% missing outcomes. In total, we will make 20 different data-sets with imputation based on a regression model using predictive-mean-matching using the MI and the MI ANALYSIS procedures in SAS. The primary outcome analysis will be made as a multiple regressions adjusted for the stratification variable if it is normally distributed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer stage 4 according to the TNM system (for patients with cancer in CNS inclusion criteria is: cancer grade three or four and no possibility of radical treatment)
- •At least 18 years
- •Live in the area of the participating hospitals
- •No contact with specialised palliative care within the previous year
- •At least one palliative need defined as a EORTC QLQ-C30 scale score of at least 50% of the score corresponding to maximal symptomatology or maximal functional impairment
- •Four additional symptoms (defined as patients answering, on average, at least 'a little' in any of the 14 function or symptom scales in the EORTC QLQ-C30 questionnaire)
- •Written informed consent
排除标准
- •Do not understand Danish well enough to participate in the study
- •Are judged incapable of co-operating with the trial protocol
研究组 & 干预措施
Standard care group
Patients continue with their standard treatment. They are instructed to contact either their GP or their hospital department if they feel that additional treatment or care is needed.
Specialised palliative care (SPC) group
Patients continue with their standard treatment (typically they receive treatment in one or more hospitals departments and from their GP). In addition, they are offered a consultation in the SPC out-patient clinic (or at home if the patient cannot attend the hospital) as soon as possible and no more than one week after randomization. If possible, each patient will have at least two contacts to the SPC in the trial period.
干预措施: Specialised palliative care (SPC) (Other)
结局指标
主要结局
Reduction in the EORTC QLQ-C30 scale that constitutes the patient's primary need
时间窗: Baseline, 3 weeks and 8 weeks
The difference between the intervention and the control group in the change from baseline to the weighted mean of the 3- and 8-week follow-up (measured as AUC) for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scale score that constitutes the primary need. The primary need can be a need related to the following: physical function, role function, emotional function, pain, shortness of breath, lack of appetite and nausea/vomiting.
次要结局
- Patients reported symptoms and problems according to the EORTC QLQ-C30(Baseline, 3 weeks and 8 weeks)
- Patient reported Satisfaction with services provided by the health care system measured with the questionnaire FAMCARE-p16(8 weeks)
- Survival(From the start of the trial to minimum three months after the end of the intervention.)
- Economical consequences(From the start of the trial to minimum three months after the end of the intervention.)
研究者
Mogens Groenvold
MD, PhD, DMSc
Bispebjerg Hospital