Longitudinal symptom burden among early phase cancer clinical trial (EP-CT) participants.

412 Background: Individuals with cancer participating in EP-CTs often experience burdensome symptoms. However, little is known about their changes in symptom burden over time and how they relate to other patient-reported outcomes (PROs) and clinical outcomes. Methods: We prospectively enrolled adults with cancer participating in EP-CTs at Massachusetts General Hospital from 4/2021-1/2023. Participants completed monthly surveys throughout EP-CT that assessed symptoms (Edmonton Symptom Assessment System ESAS), quality of life (QOL; Functional Assessment of Cancer Therapy-General FACT-G), hope (Herth Hope Index), depression/anxiety symptoms (Patient Health Questionnaire 4 PHQ4), and financial wellbeing (COST tool, higher scores indicate greater financial wellbeing). We used linear mixed models to assess associations of symptom burden over time with baseline PROs and applied Cox regression to assess correlations of symptom scores from baseline to months 1, 2, and 3 with clinical outcomes (hospitalizations, time on trial, overall survival). Results: We enrolled 196 participants (median age = 63.3 range: 31.8-88.6, 58% female, median time on trial = 60 days), with the most common cancer types gastrointestinal (34%) and breast (20%). We found no significant associations among patient characteristics and longitudinal ESAS scores. Higher baseline FACT-G emotional wellbeing (B = -.01, p = .015) correlated with improvement in longitudinal ESAS total scores. Higher baseline PHQ anxiety (B = .19, p = .035) correlated with worsening ESAS total scores. Higher baseline QOL (B = -.01, p < .001), FACT-G physical wellbeing (B = -.02, p = .003), financial wellbeing (B = -.01, p = .046), and hope (B = -.03, p < .001) scores were associated with improvement in ESAS psychological scores over time. Higher baseline PHQ depression (B = .86, p = .001) and anxiety (B = .09, p < .001) were associated with worsening ESAS psychological scores over time. The table displays associations of changes in ESAS from baseline to months 1, 2, and 3 with clinical outcomes; findings demonstrate that worsening ESAS scores from baseline to month 2 correlated with higher hospitalization risk, shorter time on trial, and worse survival. Conclusions: In this study of EP-CT participants, we found associations of baseline QOL, financial wellbeing, hope, and anxiety with symptom burden over time as well as associations between change in symptom burden and clinical outcomes. Changes from ESAS baseline to month 2 correlated with higher healthcare use, shorter time on trial, and worse survival. Future efforts to enhance EP-CT participants’ outcomes should seek to understand the underlying mechanisms of these findings. Longitudinal ESAS Hospitalization Time on Trial Survival HR P HR P HR P Baseline to Month 1 (n=171) 1.02 .106 1.01 .193 1.01 .219 Baseline to Month 2 (n=129) 1.03 .014 1.02 .017 1.02 .025 Baseline to Month 3 (n=86) 1.00 .841 1.02 .048 1.01 .364