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DOMUS研究方案:一项关于加速从肿瘤治疗向居家专业姑息治疗过渡的随机临床试验。

The DOMUS study protocol: a randomized clinical trial of accelerated transition from oncological treatment to specialized palliative care at home.

作者信息

Nordly Mie, Benthien Kirstine Skov, Von Der Maase Hans, Johansen Christoffer, Kruse Marie, Timm Helle, Vadstrup Eva Soelberg, Kurita Geana Paula, von Heymann-Horan Annika Berglind, Sjøgren Per

机构信息

Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen DK-2100, Denmark ; Department of Clinical Medicine, Faculty of Health and Medical Sciences, Copenhagen University, Copenhagen, Denmark.

Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen DK-2100, Denmark.

出版信息

BMC Palliat Care. 2014 Sep 9;13:44. doi: 10.1186/1472-684X-13-44. eCollection 2014.

Abstract

BACKGROUND

The focus of Specialized Palliative Care (SPC) is to improve care for patients with incurable diseases and their families, which includes the opportunity to make their own choice of place of care and ultimately place of death. The Danish Palliative Care Trial (DOMUS) aims to investigate whether an accelerated transition process from oncological treatment to continuing SPC at home for patients with incurable cancer results in more patients reaching their preferred place of care and death. The SPC in this trial is enriched with a manualized psychological intervention.

METHODS/DESIGN: DOMUS is a controlled randomized clinical trial with a balanced parallel-group randomization (1:1). The planned sample size is 340 in- and outpatients treated at the Department of Oncology at Copenhagen University Hospital. Patients are randomly assigned either to: a) standard care plus SPC enriched with a standardized psychological intervention for patients and caregivers at home or b) standard care alone. Inclusion criteria are incurable cancer with no or limited antineoplastic treatment options.

DISCUSSION

Programs that facilitate transition from hospital treatment to SPC at home for patients with incurable cancer can be a powerful tool to improve patients' quality of life and support family/caregivers during the disease trajectory. The present study offers a model for achieving optimal delivery of palliative care in the patient's preferred place of care and attempt to clarify challenges.

TRIAL REGISTRATION

Clinicaltrials.gov Identifier: NCT01885637.

摘要

背景

专科姑息治疗(SPC)的重点是改善对不治之症患者及其家属的护理,这包括让他们有机会自主选择护理地点以及最终的死亡地点。丹麦姑息治疗试验(DOMUS)旨在调查对于无法治愈的癌症患者,从肿瘤治疗加速过渡到在家接受持续SPC是否会使更多患者能够在他们希望的护理和死亡地点接受治疗。该试验中的SPC采用了一种手册化的心理干预措施。

方法/设计:DOMUS是一项对照随机临床试验,采用平衡的平行组随机化(1:1)。计划样本量为哥本哈根大学医院肿瘤科治疗的340名门诊和住院患者。患者被随机分配到以下两组之一:a)标准护理加对患者及其在家中的照护者进行标准化心理干预的强化SPC,或b)仅接受标准护理。纳入标准为患有无法治愈的癌症且抗肿瘤治疗选择少或没有。

讨论

对于无法治愈的癌症患者,促进从医院治疗过渡到在家接受SPC的项目可以成为提高患者生活质量以及在疾病进程中支持家庭/照护者的有力工具。本研究提供了一个在患者希望的护理地点实现最佳姑息治疗的模式,并试图阐明其中的挑战。

试验注册

Clinicaltrials.gov标识符:NCT01885637。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/57a7/4169691/62855d17f1aa/1472-684X-13-44-1.jpg

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