Patient-Reported Economic Outcomes in Modern Radiotherapy Trials

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<h3>Purpose/Objective(s)</h3> Prior research, predominately retrospective, has increased awareness that patients with cancer are at elevated risk for financial toxicity (FT), or treatment-related financial burden. With weeks of daily treatments, radiation therapy (RT) may be a particular driver of FT. Despite this, FT in patients receiving RT is less studied. The extent to which patient-reported FT outcomes are incorporated in modern, prospective studies involving RT is unknown, and we hypothesized their inclusion to be infrequent. <h3>Materials/Methods</h3> Clinicaltrials.gov was queried to identify all cancer observational or interventional studies from 2001-2020 where RT was administered. Studies with primary, secondary, or exploratory FT endpoints were identified through keyword search. For trials incorporating FT outcomes, pertinent study characteristics such as cancer type, phase, inclusion of systemic therapy and surgery, date listed, planned enrollment, and study location were collected. Detailed information regarding FT measures was recorded. The primary endpoint was the overall rate of inclusion of FT endpoints. Descriptive statistics, including frequency counts and proportions, were performed. The rates over 5-year intervals were compared using the Chi-square test (α = 0.05). <h3>Results</h3> Overall, 10,550 studies involving RT were identified, of which 88 reported FT endpoints (0.8%). 19%, 18%, and 14% of these trials were in breast, gastrointestinal, and prostate cancers, respectively. The majority were phase II/III (75%), included systemic therapy (89%) and surgery (56%), enrolled < 500 patients (84%), and conducted in the US, Canada, or Europe (81%). Included FT endpoints were typically secondary (78%), with just 15 studies (17%) including primary FT endpoints. Notably, only 19 studies (22%) reported a standalone FT endpoint. The majority measured FT as part of a larger quality of life (QoL) questionnaire, most commonly question 28 of the European Organization for Research and Treatment of Cancer Core QoL (EORTC QLQ-C30) questionnaire. The rate of inclusion of FT endpoints was 0.1%, 0.5%, 0.7%, and 1.5% for 2001-2005, 2006-2010, 2011-2015, and 2016-2020 (<i>P</i> < 0.0001), representing a significant increase over time. <h3>Conclusion</h3> FT is a major stressor, yet even after a relative increase over time, the absolute rate of inclusion of FT endpoints remains low among trials involving RT. When included, FT outcomes were typically a single question within a QoL assessment, most commonly Q28 of the EORTC QLQ-C30, which was not intended to be or validated as a standalone measure of FT from RT. This represents a significant obstacle to in-depth study and meaningful inference. The few studies addressing this issue were concentrated in Europe/North America, limiting generalizability to other racial/ethnic populations and lower income countries. To more accurately characterize and mitigate financial burden from cancer treatment, future prospective studies should include FT endpoints with greater frequency.