Coping trajectories among early phase cancer clinical trial (EPCT) participants.

Abstract

337 Background: The trajectory of coping strategies among EPCT participants likely shifts in response to treatment- and cancer-related challenges. However, little is known about how coping trajectories among EPCT participants correlate with patient factors, patient-reported outcomes (PROs), and clinical outcomes. Methods: We prospectively enrolled EPCT participants at Massachusetts General Hospital from 4/2021-1/2023. Patients completed the following PRO surveys at baseline (time of trial enrollment) and monthly thereafter: coping (Brief COPE), quality of life (QOL; FACT-G), symptoms (ESAS), hope (Herth Hope Index), and financial wellbeing (COST). We used regression models to assess associations of patient factors and baseline (B/L) PROs with changes in coping scores over time (B/L to month 1 [M1] and B/L to month 2 [M2]). We also explored how changes in coping predicted clinical outcomes (time on trial [ToT], overall survival [OS]). Results: Among 195 enrolled patients, 188 completed baseline surveys (96% response, median age=63 [range: 32-89], 56% female, most common cancer types: gastrointestinal [GI; 34%] and breast [21%]). Older age predicted higher use of emotional support (B=0.52, p=.004) and decreased positive reframing (B=-0.46, p=.048) at M1. GI cancer predicted decreased use of self-blame (B=-0.67, p=.004) and positive reframing (B=-0.66, p=.035) at M1. Head & neck (B=0.76, p=.041) and lung cancer (B=1.18, p=.018) predicted higher self-blame at M2. Higher B/L QOL predicted decreased behavioral disengagement coping at M1 (B=-0.01, p=.037) and M2 (B=-0.02, p=.001) and self-blame at M2 (B=-0.02, p=.038), as well as increased emotional support (B=0.22, p=.001) and religion (B=0.02, p=.024) coping at M1. Higher B/L ESAS symptoms predicted decreased use of emotional support at M1 (B=-0.01, p=.048). Higher B/L hope predicted increased positive reframing at M1 (B=0.07, p=.010) and religion coping at M2 (B=0.05, p=.038) as well as decreased behavioral disengagement at M1 (B=-0.04, p=.001) and M2 (B=-0.06, p=.001). Higher B/L financial wellbeing predicted increased emotional support at M1 (B=0.02, p=.025). For clinical outcomes, increased acceptance (HR=0.85, p=.028) and religion (HR=0.85, p=.016) coping at M1 and positive reframing (HR=0.84, p=.010) at M2 predicted longer ToT. Increased behavioral disengagement at M1 predicted shorter ToT (HR=1.42, p=.002). Increased positive reframing (HR=0.83, p=.009) and self-blame (HR=0.78, p=.012) coping at M1 were associated with improved OS; increased use of behavioral disengagement (HR=1.41, p=.007) predicted worse OS. Conclusions: This longitudinal cohort study of EPCT participants provides novel information about how coping trajectories correlate with patient factors, PROs, and clinical outcomes. Findings highlight opportunities for targeted interventions to address EPCT participants’ coping strategies over time to improve patient outcomes.