Loh Kah Poh, Ng Qiao Ming Rachel, Mohile Supriya G, Norton Sally, Epstein Ronald M, Sohn Michael B, Richardson Daniel, Jamy Omer, Hedjri Soroush Mortaz, Blumberg Rachel, Nafis Laura, Jensen-Battaglia Marielle, Wang Ying, Mendler Jason, Liesveld Jane, Huselton Eric J, Rodenbach Rachel, Moore Jozal, Maguire Craig, Buechler Steve M, Hodges Steve, Klepin Heidi D
James P. Wilmot Cancer Institute, Rochester, New York, USA; Division of Hematology/Oncology, Department of Medicine, University of Rochester Medical Center, Rochester, New York, USA.
Duke-NUS Medical School, Singapore; Department of Geriatric Medicine, Singapore General Hospital, Outram Road, Singapore.
J Geriatr Oncol. 2025 Mar;16(2):102187. doi: 10.1016/j.jgo.2025.102187. Epub 2025 Jan 18.
Therapeutic advances have allowed more adults aged ≥60 years with acute myeloid leukemia (AML) to receive life-prolonging treatments, with improvement in overall survival. In contrast to other cancers, the onset of AML is often sudden, high-risk treatment decisions must be made quickly, and survival is often compromised due to aging-related conditions (e.g., functional impairments). Studies have demonstrated that up to 78 % of older adults with AML and their caregivers experience significant psychological distress. Distress is associated with poor quality of life, increased healthcare utilization, and increased mortality. Shared decision making (SDM) can reduce patient and caregiver distress and is essential to achieve goal-concordant care. Therefore, interventions to alleviate distress and optimize SDM in older adults with AML and their caregivers are needed. We will conduct a multicenter randomized controlled trial to evaluate the efficacy of University of Rochester-Geriatric Oncology assessment for Acute myeloid Leukemia (UR-GOAL) compared to an attention control for reducing patient distress and improving observed SDM, patient-perceived SDM, and decisional conflict.
We will recruit 300 patients aged ≥60 years with newly diagnosed AML, their caregivers (one caregiver per patient when available), and up to 40 oncologists from four institutions: (1) Patients will view an educational video about AML diagnosis, treatment, and prognosis; complete the Best Worst Scaling values clarification process; and review a summary report of their values with tailored question prompts and resources; (2) Caregivers will view the same educational video and receive the same summary report as patients; and (3) Oncologists will review a summary report of the patient's aging-related conditions, perception of prognosis, and values. Patients, caregivers, and oncologists will then meet during clinical visits to discuss aging-related conditions, prognosis, and patient values, and reach a treatment decision. The primary outcome measure is distress (Distress Thermometer). Secondary outcome measures include observed SDM, patient perceived SDM, and decisional conflict.
This study will address significant knowledge gaps related to reducing distress and decisional conflict and improving SDM in older adults with AML. If successful, this research will inform future decisional interventions for a broader group of patients.
治疗方面的进展使更多60岁及以上的急性髓系白血病（AML）成人患者能够接受延长生命的治疗，总体生存率有所提高。与其他癌症不同，AML的发病通常很突然，必须迅速做出高风险的治疗决策，而且由于与衰老相关的状况（如功能障碍），生存率往往受到影响。研究表明，高达78%的老年AML患者及其护理人员会经历严重的心理困扰。困扰与生活质量差、医疗保健利用率增加和死亡率上升有关。共同决策（SDM）可以减轻患者和护理人员的困扰，对于实现目标一致的护理至关重要。因此，需要采取干预措施来减轻老年AML患者及其护理人员的困扰并优化共同决策。我们将进行一项多中心随机对照试验，以评估罗切斯特大学老年肿瘤学急性髓系白血病评估（UR-GOAL）与注意力对照组相比，在减轻患者困扰、改善观察到的共同决策、患者感知的共同决策和决策冲突方面的疗效。
我们将招募300名60岁及以上新诊断为AML的患者、他们的护理人员（如有可能，每位患者一名护理人员）以及来自四个机构的多达40名肿瘤学家：（1）患者将观看一段关于AML诊断、治疗和预后的教育视频；完成最佳最差标度值澄清过程；并通过量身定制的问题提示和资源查看他们价值观的总结报告；（2）护理人员将观看与患者相同的教育视频并收到相同的总结报告；（3）肿瘤学家将查看患者与衰老相关状况、预后感知和价值观的总结报告。然后，患者、护理人员和肿瘤学家将在临床就诊期间会面，讨论与衰老相关的状况、预后和患者价值观，并做出治疗决策。主要结局指标是困扰（困扰温度计）。次要结局指标包括观察到的共同决策、患者感知的共同决策和决策冲突。
本研究将解决与减轻老年AML患者的困扰和决策冲突以及改善共同决策相关的重大知识空白。如果成功，这项研究将为更广泛患者群体的未来决策干预提供信息。
