多中心、整群随机、III 期、比较性临床试验方案：老年非小细胞肺癌患者的老年综合评估：ENSURE-GA 研究。

Protocol for a multi-site, cluster-randomized, phase III, comparative clinical trial of geriatric assessment of older patients with non-small-cell lung cancer: the ENSURE-GA study.

机构信息

Department of Internal Medicine, Division of Medical Oncology & Respiratory Medicine, Shimane University Faculty of Medicine, 89-1 Enya-cho, 693-8501, Izumo, Shimane, Japan.

Department of Respiratory Medicine, Saitama Medical University International Medical Center, 397-1 Yamane, 350-1298, Hidaka, Saitama, Japan.

出版信息

BMC Geriatr. 2021 Jan 22;21(1):74. doi: 10.1186/s12877-021-02028-w.

DOI:10.1186/s12877-021-02028-w

PMID:33482741

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7821507/

Abstract

BACKGROUND

In Japan, approximately half of all lung cancer patients are aged > 75 years, and the proportion of older patients is increasing. In older patients, it is necessary to consider comorbidities and concomitant drug use to ensure optimal cancer treatment; however, geriatric assessment (GA) is not widely performed. We plan to conduct a study (ENSURE-GA) of GA in older lung cancer patients to determine whether GA with intervention improves patient satisfaction with their treatment.

METHODS

The study will be a phase III comparative clinical trial with a cluster-randomized design, and it will be conducted at 81 sites distributed throughout Japan. Approximately 1000 lung cancer patients aged ≥ 75 years will be enrolled in the study. All participants will undergo a standardized GA before starting treatment (using an iPad). At the intervention sites, the GA results and intervention method recommended on the basis of the GA results will be returned as an instant report to guide the physician's choice of intervention. At the control sites, the physician will decide on interventions based on standard practice. All participants will complete a patient satisfaction survey before treatment initiation (after the GA) and 3 months later.

DISCUSSION

The purpose of the ENSURE-GA study is to evaluate whether GA with interventions improves patient satisfaction with treatment outcomes. The study may lead to the increased use of GA and improved treatment of cancer in older adults. The results will also be used to prepare guidelines for treating older cancer patients and will provide a foundation for the development of a standardized geriatric oncology system.

TRIAL REGISTRATION

The study has been registered in the University Hospital Medical Information Network database (no. UMIN000037590). The registration date is August 4, 2019, and the protocol version is 2.0. ( https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000042853 .).

摘要

背景

在日本，约有一半的肺癌患者年龄超过 75 岁，且老年患者的比例还在不断增加。对于老年患者，有必要考虑合并症和伴随用药，以确保癌症治疗的最佳效果；然而，老年综合评估（GA）并未得到广泛应用。我们计划开展一项针对老年肺癌患者 GA 的研究（ENSURE-GA），以确定 GA 干预是否能提高患者对治疗的满意度。

方法

该研究是一项采用集群随机设计的 III 期对比临床试验，将在日本分布的 81 个研究点开展。约 1000 名年龄≥75 岁的肺癌患者将参加这项研究。所有参与者在开始治疗前（使用 iPad）都将接受标准化的 GA。在干预点，GA 结果和基于 GA 结果推荐的干预方法将作为即时报告返回，以指导医生选择干预措施。在对照点，医生将根据标准实践来决定干预措施。所有参与者将在治疗开始前（GA 后）和 3 个月后完成一次患者满意度调查。