Lindberg-Scharf Patricia, Emmert Martin, Koller Michael, Gürtler Florian, Steinger Brunhilde, Müller-Nordhorn Jacqueline, Zeman Florian, Friebel Sophie, Ibler Ksenia, Kurz Jan, Stangl Thomas, Klinkhammer-Schalke Monika, Völkel Vinzenz
Tumor Center Regensburg, Center of Quality Management and Health Services Research, University of Regensburg, Am BioPark 9, 93053, Regensburg, Germany.
Institute for Healthcare Management and Health Sciences, Faculty of Law, Business and Economics, University of Bayreuth, Universitätsstraße 30, 95447, Bayreuth, Germany.
Trials. 2025 Sep 16;26(1):339. doi: 10.1186/s13063-025-09102-3.
In routine oncological care, the implementation of disease-related quality of life (QoL) is still an open matter. In a complex intervention, a QoL monitoring system including tailored therapeutic options has been designed, implemented, and its effectiveness has been demonstrated in two randomised trials in patients with breast and colorectal cancer. The next step is to extend the usability of the QoL monitoring system for patients with other cancer diagnoses and in other regions. Necessary adaptations include an electronic measurement of QoL and consideration of patient and physician preferences. The present randomised trial investigates the effectiveness of this adapted QoL monitoring system in patients with lung cancer in two regions in Bavaria, Germany.
In this 2-arm randomised, prospective, pragmatic, multicentre clinical trial with one intervention and one control group, QoL of primary lung cancer patients is assessed with an electronic patient- and physician-oriented QoL monitoring system using the EORTC QLQ-C30 and QLQ-LC29 questionnaires at study entry and at 1, 2, 3, 4, 5, and 6 months during follow-up care. The QoL data of each patient are linked with clinical data from the Bavarian Cancer Registry for the purpose of data analysis. In the intervention group, the results of QoL monitoring are automatically transferred to a QoL profile including 8 dimensions on scales of 0-100 (cut-off "need for QoL therapy" < 50 points). QoL results are obtained in real-time by patients and their treating physicians. To treat QoL deficits, a multi-professional network of healthcare providers is established. In the control group, QoL is also measured, but neither patients nor treating physicians have access to the results. The investigators expect that the proportion of patients in both groups with a need for QoL therapy (< 50 points in at least one dimension of the QoL profile) will be lower in the intervention group than in the control group at the primary endpoint 6 months after study entry.
This is the first study investigating the effectiveness of a QoL monitoring system based on patient- and physician-oriented preferences with a high degree of generalisability by including inpatient and outpatient care as well as different study regions.
ClinicalTrials.gov NCT06252233. Registered on February 2024.
在常规肿瘤护理中，实施与疾病相关的生活质量（QoL）仍是一个悬而未决的问题。在一项复杂干预措施中，设计并实施了一个包括量身定制治疗方案的QoL监测系统，并且在两项针对乳腺癌和结直肠癌患者的随机试验中证明了其有效性。下一步是将QoL监测系统的可用性扩展到其他癌症诊断患者以及其他地区。必要的调整包括对QoL进行电子测量以及考虑患者和医生的偏好。本随机试验在德国巴伐利亚州的两个地区调查这种经过调整的QoL监测系统对肺癌患者的有效性。
在这项双臂随机、前瞻性、务实的多中心临床试验中，设有一个干预组和一个对照组，使用欧洲癌症研究与治疗组织（EORTC）的QLQ - C30和QLQ - LC29问卷，通过一个以患者和医生为导向的电子QoL监测系统，在研究开始时以及随访护理的第1、2、3、4、5和6个月对原发性肺癌患者的QoL进行评估。为了进行数据分析，将每位患者的QoL数据与巴伐利亚癌症登记处的临床数据相关联。在干预组中，QoL监测结果会自动传输到一个QoL概况中，该概况包括8个维度，范围为0 - 100分（“需要QoL治疗”的临界值<50分）。患者及其治疗医生可实时获取QoL结果。为了治疗QoL缺陷，建立了一个多专业医疗服务提供者网络。在对照组中，也测量QoL，但患者和治疗医生都无法获取结果。研究人员预计，在研究开始6个月后的主要终点时，干预组中需要QoL治疗（QoL概况中至少一个维度<50分）的患者比例将低于对照组。
这是第一项研究基于患者和医生偏好的QoL监测系统有效性的研究，通过纳入住院和门诊护理以及不同的研究地区，具有高度的普遍性。
ClinicalTrials.gov NCT06252233。于2024年2月注册。
