James P. Wilmot Cancer Center, University of Rochester Medical Center, NY, USA.
James P. Wilmot Cancer Center, University of Rochester Medical Center, NY, USA.
J Geriatr Oncol. 2024 Mar;15(2):101687. doi: 10.1016/j.jgo.2023.101687. Epub 2024 Feb 1.
Polypharmacy is prevalent in older adults with cancer and associated with multiple adverse outcomes. A single-site, cluster-randomized clinical trial will enroll older adults with cancer and polypharmacy starting chemotherapy and will assess the effectiveness and feasibility of deprescribing interventions by comparing two arms: a pharmacist-led deprescribing intervention and a patient educational brochure.
The study will be conducted in two phases. In phase I, focus groups and semi-structured individual interviews will guide adaptation of deprescribing interventions for the oncology clinic (phase Ia), and eight patients will undergo the pharmacist-led deprescribing intervention with iterative adaptations (phase Ib). In phase II, a pilot cluster-randomized trial (n = 72) will compare a pharmacist-led deprescribing intervention with a patient education brochure, with treating oncologists as the cluster. Both efficacy (relative dose intensity of planned chemotherapy, potentially inappropriate medications successfully deprescribed, chemotherapy toxicity, functional status, hospitalizations, falls, and symptoms) and implementation outcomes (barriers and facilitators) will be assessed.
This study is anticipated to provide pilot data to inform a nationwide randomized clinical trial of deprescribing in older adults starting cancer treatment. The cluster randomization is intended to provide an initial estimate for the intervention effect as well as oncologists' intra-class correlation coefficient. Deprescribing interventions may improve outcomes in older adults starting cancer treatment, but these interventions are understudied in this population, and it is unknown how best to implement them into oncology practice. The results of this trial will inform the design of large, randomized phase III trials of deprescribing.
gov Identifier:NCT05046171. Date of registration: September 16, 2021.
癌症老年患者普遍存在多重用药的情况，且与多种不良结局相关。一项单中心、整群随机临床试验将招募开始化疗的癌症且多重用药的老年患者，并通过比较两个组（药师主导的药物减量干预和患者教育手册）来评估药物减量干预的有效性和可行性。
研究将分两个阶段进行。在第一阶段，将进行焦点小组和半结构化个体访谈，以指导为肿瘤诊所改编药物减量干预（阶段 Ia），并对 8 名患者进行迭代改编的药师主导的药物减量干预（阶段 Ib）。在第二阶段，将进行一项试点整群随机试验（n=72），比较药师主导的药物减量干预与患者教育手册，以治疗肿瘤医生为群。将评估疗效（计划化疗的相对剂量强度、成功减量的潜在不适当药物、化疗毒性、功能状态、住院、跌倒和症状）和实施结果（障碍和促进因素）。
这项研究预计将提供初步数据，为全国范围内开始癌症治疗的老年患者药物减量的随机临床试验提供信息。整群随机化旨在为干预效果以及肿瘤医生的组内相关系数提供初步估计。药物减量干预可能改善开始癌症治疗的老年患者的结局，但这些干预措施在该人群中研究较少，并且尚不清楚如何将其最好地纳入肿瘤学实践。该试验的结果将为大规模、随机 III 期药物减量试验的设计提供信息。
gov 标识符：NCT05046171。注册日期：2021 年 9 月 16 日。
