Department of Palliative Medicine, The Research Unit, Bispebjerg Hospital 20D, Bispebjerg Bakke 23, DK-2400 Copenhagen, NV,Denmark.
BMC Palliat Care. 2013 Oct 24;12(1):37. doi: 10.1186/1472-684X-12-37.
Advanced cancer patients experience considerable symptoms, problems, and needs. Early referral of these patients to specialised palliative care (SPC) could improve their symptoms and problems.The Danish Palliative Care Trial (DanPaCT) investigates whether patients with metastatic cancer, who report palliative needs in a screening, will benefit from being referred to 'early SPC'.
METHODS/DESIGN: DanPaCT is a clinical, multicentre, parallel-group superiority trial with balanced randomisation (1:1). The planned sample size is 300 patients. Patients are randomised to specialised palliative care (SPC) plus standard treatment versus standard treatment. Consecutive patients from oncology departments are screened for palliative needs with a questionnaire if they: a) have metastatic cancer; b) are 18 years or above; and c) have no prior contact with SPC. Patients with palliative needs (i.e. symptoms/problems exceeding a certain threshold) according to the questionnaire are eligible. The primary outcome is the change in the patients' primary need (the most severe symptom/problem measured with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)). Secondary outcomes are other symptoms/problems (EORTC QLQ-C30), satisfaction with health care (FAMCARE P-16), anxiety and depression (the Hospital Anxiety and Depression scale), survival, and health care costs.
Only few trials have investigated the effects of SPC. To our knowledge DanPaCT is the first trial to investigate screening based 'early SPC' for patients with a broad spectrum of cancer diagnosis.
Current controlled Trials NCT01348048.
晚期癌症患者会经历大量的症状、问题和需求。将这些患者尽早转介至专业的姑息治疗（SPC）可改善他们的症状和问题。丹麦姑息治疗试验（DanPaCT）旨在研究在筛查中报告姑息治疗需求的转移性癌症患者是否能从转介至“早期 SPC”中获益。
方法/设计：DanPaCT 是一项临床、多中心、平行组优效性试验，采用平衡随机分组（1:1）。计划样本量为 300 例患者。符合以下条件的肿瘤内科患者连续入组，进行姑息治疗需求筛查：a）患有转移性癌症；b）年龄 18 岁及以上；c）与 SPC 无既往接触。根据问卷，存在姑息治疗需求（即症状/问题超过一定阈值）的患者符合入组条件。主要结局为患者主要需求的变化（使用欧洲癌症研究与治疗组织生活质量问卷（EORTC QLQ-C30）测量的最严重症状/问题）。次要结局为其他症状/问题（EORTC QLQ-C30）、医疗保健满意度（FAMCARE P-16）、焦虑和抑郁（医院焦虑和抑郁量表）、生存和医疗保健费用。
只有少数试验研究了 SPC 的效果。据我们所知，DanPaCT 是第一项研究广泛癌症诊断患者基于筛查的“早期 SPC”的试验。
当前对照试验 NCT01348048。
