Pompili Cecilia, Franks Kevin N, Brunelli Alessandro, Hussain Yusuf S, Holch Patricia, Callister Matthew E, Robson Jonathan M, Papagiannopoulos Kostas, Velikova Galina
University of Leeds, Section of Patient Centered Outcomes Research, Leeds Institute of Cancer and Pathology, St. James's University Hospital, Leeds LS9 7TF, UK.
Department of Clinical Oncology, St. James's University Hospital, Leeds Teaching Hospital NHS Trust, Leeds LS9 7TF, UK.
J Thorac Dis. 2017 Aug;9(8):2703-2713. doi: 10.21037/jtd.2017.07.35.
Lung cancer is increasingly a disease of the elderly and frail population with a median age of 70 years at diagnosis. Therefore, consideration of the impact of interventions on health-related quality of life (HRQOL) and not only absolute survival is especially important. For non-small cell lung cancer (NSCLC), video-assisted thoracoscopic surgery (VATS) has been gaining popularity over the last few decades, replacing traditional open lobectomies. For high-risk patients who are not deemed suitable for surgery, stereotactic ablative body radiotherapy (SABR) provides a potentially curative alternative. However, little is known about how VATS and SABR affect HRQOL measured using patient reported outcome measures (PROMs). The LiLAC study (Life after Lung Cancer) aims to explore HRQOL following intervention with VATS or SABR using validated PROMs and to pilot the use of an online questionnaire system (QTool) in this setting. We hope the results will aid both patients and clinicians in decision making and improve the management of post-intervention problems.
In total, 300 patients (150 VATS and 150 SABR) patients will be recruited over the study period. Patients will be approached prior to intervention and asked to complete baseline HRQOL questionnaires. They will be given access to the QTool online system and then in the 12 months following intervention will be asked to complete questionnaires (paper or online) at 4-time points. Answers will available for patients and clinicians to view throughout the study period. Clinical information (age, gender, co-morbidity, current medications and smoking status along with treatment-specific information) will also be collected. Primary outcome will be to detect changes of PROs (HRQOL and patient satisfaction) after VATS lung resections or SABR in early stage lung cancer patients. Secondary outcomes include correlation of patient's clinical data with HRQOL results to identify predictors of poor outcomes and exploration of patient and clinician views on the usefulness of QOL measurements.
(I) This first study will primarily compare multiple patients reported outcomes for 12 months after VATS lobectomy and SABR in early stages NSCLC patients. We will explore the acceptability of an online assessment of the HRQOL in NSCLC patients. (II) The study is also focused on the patients' opinion during the shared decision-making process, which has rarely been investigated in surgical lung cancer patients. (III) This is not a randomised trial. As a consequence, inherent cohort selection bias and unknown or unaccounted confounders correlated with the outcome of interest may influence the results of the comparison between the treatment groups. (IV) LILAC is not looking at a direct comparison, but to depict the trajectory of recovery post-treatments and preservation or improvement of the HRQOL. This study has received ethical approval from NRES Yorkshire and the Humber- Leeds East Research Ethics Committee (REC Ref: 16/YH/0407). Results of this study will be shared with participating hospitals and made available to the academic community through submission for publication in international peer-reviewed journals and presentation at relevant national and international conferences.
ClinicalTrials.gov Identifier: NCT02882750.
肺癌越来越成为一种老年和体弱人群的疾病，诊断时的中位年龄为70岁。因此，考虑干预措施对健康相关生活质量（HRQOL）的影响而非仅仅是绝对生存率尤为重要。对于非小细胞肺癌（NSCLC），在过去几十年中，电视辅助胸腔镜手术（VATS）越来越受欢迎，取代了传统的开胸肺叶切除术。对于被认为不适合手术的高危患者，立体定向消融体部放疗（SABR）提供了一种潜在的治愈性替代方案。然而，关于VATS和SABR如何影响使用患者报告结局指标（PROMs）测量的HRQOL，人们知之甚少。LiLAC研究（肺癌后的生活）旨在使用经过验证的PROMs探索VATS或SABR干预后的HRQOL，并在此背景下试点使用在线问卷系统（QTool）。我们希望结果将有助于患者和临床医生进行决策，并改善干预后问题的管理。
在研究期间总共将招募300名患者（150名接受VATS和150名接受SABR）。在干预前与患者联系，并要求他们完成基线HRQOL问卷。将让他们使用QTool在线系统，然后在干预后的12个月内，要求他们在4个时间点完成问卷（纸质或在线）。在整个研究期间，患者和临床医生都可以查看答案。还将收集临床信息（年龄、性别、合并症、当前用药和吸烟状况以及特定治疗信息）。主要结局将是检测早期肺癌患者接受VATS肺切除或SABR后PROs（HRQOL和患者满意度）的变化。次要结局包括患者临床数据与HRQOL结果的相关性，以确定不良结局的预测因素，以及探索患者和临床医生对QOL测量有用性的看法。
（I）这项首次研究将主要比较早期NSCLC患者接受VATS肺叶切除和SABR后12个月的多个患者报告结局。我们将探索NSCLC患者HRQOL在线评估的可接受性。（II）该研究还关注患者在共同决策过程中的意见，这在肺癌手术患者中很少被研究。（III）这不是一项随机试验。因此，固有的队列选择偏倚以及与感兴趣的结局相关的未知或未考虑的混杂因素可能会影响治疗组之间比较的结果。（IV）LiLAC研究并非进行直接比较，而是描绘治疗后的恢复轨迹以及HRQOL的维持或改善情况。本研究已获得英国国家研究伦理服务机构约克郡和亨伯-利兹东部研究伦理委员会的伦理批准（伦理审查参考号：16/YH/0407）。本研究的结果将与参与医院分享，并通过提交至国际同行评审期刊发表以及在相关国内和国际会议上展示，供学术界使用。
ClinicalTrials.gov标识符：NCT02882750。
