Health Care Contact Days and Outcomes in Clinical Trials vs Routine Care Among Patients With Non–Small Cell Lung Cancer
Authors: Arjun Gupta, Paul Nguyen, Brooke E. Wilson, Christopher M. Booth, Timothy P. Hanna
Journal: JAMA Network Open (2025)

Importance Although patients enrolled in trials have superior survival outcomes compared with those in routine practice, it is unknown whether such differences extend to contact days, a measure of time toxicity. Objective To evaluate differences in contact days for patients with advanced stage non–small cell lung cancer (NSCLC) receiving care in trials or routine practice. Design, Setting, and Participants This population-based, retrospective, matched cohort study assessed adults from Ontario, Canada, who were diagnosed with advanced-stage NSCLC between January 1, 2010, and December 31, 2017, and who died between January 1, 2010, and December 31, 2019. The maximum follow-up time from diagnosis was 2 years. Data analysis was performed from May 5, 2024, to October 22, 2024. Exposure Patients receiving specific, systemic, palliative-intent, cancer-directed drug(s) as part of a trial were matched 1:1 with patients who received the same drug(s) after approval in routine practice in the same line of treatment. Main Outcomes and Measures Contact days (days with in-person health care contact) were identified through administrative claims data. Models were fitted with cubic splines to describe trajectories of weekly percentage of contact days. Results Of the 250 patients (mean [SD] age, 63.6 [9.2] years; 140 [56.0%] male), 125 were trial participants and 125 were receiving care in routine practice. Trial participants were younger (median [IQR] age, 63 [56-69] years vs 64 [58-70] years in routine care patients; standardized difference, 0.21) and had fewer comorbidities (eg, hypertension [45 (36.0%) vs 59 (47.2%); standardized difference, 0.23]). Median (IQR) contact days from diagnosis to death were higher for trial participants compared with those in routine practice (79 [62-104] vs 68 [46-98] days; standardized difference, 0.26). However, trial participants had a longer median (IQR) overall survival (eg, 12.8 [8.7-18.0] vs 10.5 [5.2-14.7] months; standardized difference, 0.46) and a slightly lower median percentage of contact days after adjusting for survival (20.3% [95% CI, 18.1%-21.7%] vs 21.2% [95% CI, 19.3%-25.7%]). During treatment, trial participants experienced a lower median percentage of contact days (18.4% [95% CI, 16.3%-20.8%] vs 25.5% [95% CI, 20.7%-30.3%]); inpatient care accounted for 18.5% (95% CI, 11.1%-29.6%) of on-treatment contact days for trial participants vs 40.0% (95% CI, 30.0%-47.6%) in routine practice. Normalized contact-day trajectories were U-shaped for all groups, with lower peaks and troughs among trial participants. Conclusions and Relevance In this population-based cohort study, patients receiving systemic therapy as part of trials experienced a lower percentage of contact days, accounted for by greater hospitalization rates in routine practice. Addressing the predominantly outpatient, protocol-mandated visits may represent opportunities to decrease trial-related time toxicity.