Understanding health-related quality of life measures used in early-stage non-small cell lung cancer clinical trials: A review

Health-related quality of life (HRQoL) is an important consideration in cancer clinical research, which can be substantially influenced by cancer treatment procedures and medications. The treatment landscape for early-stage (stage I–III) non-small cell lung cancer (NSCLC) is rapidly evolving. In this light, it is important to evaluate the most suitable instruments for HRQoL assessment and timing. Given there is often a requirement for patients with early-stage disease to receive long-term treatment to reduce the risk of disease recurrence after surgery, maintenance or improvement in HRQoL is an important goal of both neoadjuvant and adjuvant treatments. Key challenges with assessing HRQoL relate to the suitability of existing instruments to measure relevant treatment-related adverse effects, consistency in HRQoL assessment approach between similar studies, gaps in data collection and reporting, and interpretation of longitudinal data. Frequent assessments during and after treatment are warranted to capture the true impact of treatment and disease progression on HRQoL, and changes in the relative importance of these factors over time. There is scope for improving existing HRQoL approaches, including ease of use and integration of digital tools to facilitate analysis and interpretation, to enhance the experience of both patients and healthcare professionals. In this narrative review, we discuss key considerations for HRQoL assessment and evaluate the tools currently available to measure HRQoL in NSCLC, many of which were designed with advanced disease in mind. We focus on the key challenges of measuring HRQoL for the specific needs of patients with early-stage disease, and consider future perspectives, to determine the most appropriate HRQoL instruments and analysis methods to use in early-stage NSCLC clinical trials.¹