Associations of symptom burden with patient-reported outcomes and clinical outcomes among early phase cancer clinical trial participants.

PURPOSE: Individuals with cancer often endure a substantial symptom burden. However, little is known about the symptom burden of patients with cancer participating in early phase cancer clinical trials (EPCT).

METHODS

We prospectively enrolled adults with cancer participating in EPCTs at Massachusetts General Hospital from 4/2021-1/2023. Participants completed surveys prior to EPCT initiation that assessed symptoms (Edmonton Symptom Assessment System [ESAS]), quality of life (QOL; Functional Assessment of Cancer Therapy-General), depression/anxiety symptoms (Patient Health Questionnaire-4), and financial well-being (COST). We used regression models to explore associations of symptom burden with patient-reported outcomes and clinical outcomes.

RESULTS

Among 195 patients enrolled, 185 participants completed the surveys (94.9% response rate). Participants had a median age of 63.5 years (range: 31.8-88.6) and 57.3% were female. Most common cancer types were gastrointestinal and breast. Median survival was 7.82 (IQR: 3.88-18.71) months, and median follow-up time was 12.20 (IQR: 7.99-16.80) months. Participants reported moderate/severe fatigue (51.7%), poor well-being (49.7%), drowsiness (36.2%), pain (26.4%), and lack of appetite (25.8%). Higher ESAS-total scores and greater number of moderate/severe symptoms were associated with lower QOL, increased depression/anxiety symptoms, and worse financial well-being (p-values < 0.05 for all). Higher ESAS-total scores (HR:1.02, p < 0.001) were associated with worse overall survival.

CONCLUSION

Among EPCT participants, higher symptom burden at time of clinical trial initiation correlated with decreased QOL, increased depression/anxiety symptoms, worse financial well-being, shorter time on trial, and worse overall survival. Interventions seeking to enhance care delivery and outcomes for EPCT participants should strive to address the symptom burden of this population.