Department of Hematology, Copenhagen University Hospital, Copenhagen, Denmark
CASTLE - Cancer Survivorship and Treatment Late Effects Research Unit, Department of Oncology, Copenhagen University Hospital, Copenhagen, Denmark.
BMJ Open. 2024 May 21;14(5):e085163. doi: 10.1136/bmjopen-2024-085163.
To support the implementation of advance care planning and serious illness conversations in haematology, a previously developed conversation intervention titled 'Advance Consultations Concerning your Life and Treatment' (ACT) was found feasible. This study aims to investigate the effect of ACT on the quality of end-of-life care in patients with haematological malignancy and their informal caregivers.
The study is a nationwide 2-arm cluster randomised trial randomising 40 physician-nurse clusters across seven haematological departments in Denmark to provide standard care or ACT intervention. A total of 400 patients with haematological malignancies and their informal caregivers will be included. The ACT intervention includes an ACT conversation that centres on discussing the patient's prognosis, worries, hopes and preferences for future treatment. The intervention is supported by clinician training and supervision, preparatory materials for patients and informal caregivers, and system changes including dedicated ACT-conversation timeslots and templates for documentation in medical records.This study includes two primary outcomes: (1) the proportion of patients receiving chemotherapy within the last 30 days of death and (2) patients' and informal caregivers' symptoms of anxiety (General Anxiety Disorder-7) at 3 6, 9, 12 and 18 months follow-up. Mixed effects models accounting for clusters will be used.
The Declaration of Helsinki and the European GDPR regulations as practised in Denmark are followed through all aspects of the study. Findings will be made available to the participants, patient organisations, funding bodies, healthcare professionals and researchers at national and international conferences and through publication in peer-reviewed international journals.
The study is registered at ClinicalTrials.gov (NCT05444348). The Regional Ethics Committee of the Capital Region of Denmark (record no: 21067634) has decided that approval is not necessary as per Danish legislation. Study approval has been obtained from The Capital Region of Denmark Data Protection Agency (record no: P-2022-93).
NCT05444348.
为了支持在血液学中实施预先护理计划和严重疾病对话，先前开发的一项名为“关于您的生命和治疗的预先咨询”（ACT）的对话干预措施被证明是可行的。本研究旨在调查 ACT 对血液恶性肿瘤患者及其非正式照护者的临终关怀质量的影响。
该研究是一项全国性的 2 臂聚类随机试验，将丹麦 7 个血液学部门的 40 个医生-护士聚类随机分配到提供标准护理或 ACT 干预。总共将纳入 400 名血液恶性肿瘤患者及其非正式照护者。ACT 干预包括围绕讨论患者预后、担忧、希望和对未来治疗的偏好展开的 ACT 对话。该干预措施得到了临床医生培训和监督、患者和非正式照护者的预备材料以及系统改变的支持，包括专门的 ACT 对话时段和医疗记录中的模板。本研究包括两个主要结果：（1）在死亡前 30 天内接受化疗的患者比例；（2）患者和非正式照护者在 3、6、9、12 和 18 个月随访时的焦虑症状（一般焦虑障碍-7）。将使用考虑聚类的混合效应模型。
本研究遵循《赫尔辛基宣言》和丹麦实践的《欧洲 GDPR 法规》的所有方面。研究结果将提供给参与者、患者组织、资助机构、医疗保健专业人员和研究人员，在国家和国际会议上，并通过在同行评议的国际期刊上发表。
该研究在 ClinicalTrials.gov 注册（NCT05444348）。丹麦首都大区伦理委员会（记录编号：21067634）决定，根据丹麦立法，无需批准。该研究已获得丹麦首都大区数据保护局的批准（记录编号：P-2022-93）。
NCT05444348。
