BACKGROUND Patients with advanced haematological malignancies suffer from a very high symptom burden and psychological, spiritual, social and physical symptoms comparable with patients with metastatic non-haematological malignancy. Referral to palliative care services for these patients remains limited or often confined to the last days of life. We developed a palliative care intervention (PCI) integrated with standard haematological care. The aim of the study was focussed on exploring the feasibility of the intervention by patients, professionals and caregivers and on assessing its preliminary efficacy. METHODS/DESIGN This is a mixed-methods phase 2 trial. The Specialist Palliative Care Team (SPCT) will follow each patient on a monthly basis in the outpatient clinic or will provide consultations during any hospital admission. SPCT and haematologists will discuss active patient issues to assure a team approach to the patient's care. This quantitative study is a monocentric parallel-group superiority trial with balanced randomisation comparing the experimental PCI plus haematological standard care versus haematological standard care alone. The primary endpoint will calculate on adherence to the planned PCI, measured as the percentage of patients randomised to the experimental arm who attend all the planned palliative care visits in the 24 weeks after randomisation. The qualitative study follows the methodological indications of concurrent nested design and was aimed at exploring the acceptability of the PCI from the point of view of patients, caregivers and physicians. DISCUSSION In this trial, we will test the feasibility of an integrated palliative care approach starting when the haematologist decides to propose the last active treatment to the patient, according to his/her clinical judgement. We decided to test this criterion because it is able to intercept a wide range of patients'needs. The feasibility of this approach requires that we enrol at least 60 patients and that more than 50% of them be followed by the palliative care team for at least 24 weeks. The trial will include integrated qualitative data analysis; to give essential information on feasibility and acceptability. TRIAL REGISTRATION ClinicalTrials.gov: NCT03743480 (November 16, 2018).

中文翻译：

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血液癌症患者最后一次积极治疗的早期姑息治疗与标准治疗：一项可行性试验的研究方案。

背景技术与转移性非血液系统恶性肿瘤的患者相比，晚期血液系统恶性肿瘤的患者具有非常高的症状负担以及心理，精神，社会和身体症状。这些患者转诊至姑息治疗服务的机会仍然有限，或者通常仅限于生命的最后几天。我们开发了与标准血液学护理相集成的姑息护理干预（PCI）。该研究的目的集中在探索患者，专业人士和护理人员进行干预的可行性以及评估其初步疗效。方法/设计这是一项混合方法的2期试验。专家姑息治疗小组（SPCT）将每月在门诊诊所跟踪每位患者，或在任何住院期间提供咨询。SPCT和血液学家将讨论积极的患者问题，以确保采用团队方法来护理患者。这项定量研究是一项单中心平行组优势试验，采用均衡随机分组比较了实验性PCI加血液学标准护理与单独的血液学标准护理。主要终点指标将根据对计划PCI的依从性进行计算，以在随机分配后24周内接受所有计划姑息治疗就诊的随机分配到实验组的患者百分比来衡量。定性研究遵循并发嵌套设计的方法学指标，旨在从患者，护理人员和医生的角度探讨PCI的可接受性。讨论在这个审判中，我们将根据患者的临床判断，从血液学家决定对患者提出最后的积极治疗开始，测试综合姑息治疗方法的可行性。我们决定测试此标准，因为它可以拦截各种患者的需求。这种方法的可行性要求我们招募至少60名患者，姑息治疗团队应将至少50％的患者随访至少24周。该试验将包括综合的定性数据分析；提供有关可行性和可接受性的基本信息。试验注册ClinicalTrials.gov：NCT03743480（2018年11月16日）。我们决定测试此标准，因为它可以拦截各种患者的需求。这种方法的可行性要求我们招募至少60名患者，姑息治疗团队应将至少50％的患者随访至少24周。该试验将包括综合的定性数据分析；提供有关可行性和可接受性的基本信息。试验注册ClinicalTrials.gov：NCT03743480（2018年11月16日）。我们决定测试此标准，因为它可以拦截各种患者的需求。这种方法的可行性要求我们招募至少60名患者，姑息治疗团队应将至少50％的患者随访至少24周。该试验将包括综合的定性数据分析；提供有关可行性和可接受性的基本信息。试验注册ClinicalTrials.gov：NCT03743480（2018年11月16日）。