Longitudinal changes in patient-reported quality of life (QOL) and hope among early phase cancer clinical trial (EPCT) participants.

Abstract

11015 Background: Few studies have explored associations of longitudinal changes in patient-reported outcomes (PROs) and clinical outcomes among EPCT participants. We sought to describe changes in hope and QOL over the first two months of EPCT participation and examine associations of these changes with clinical outcomes. Methods: We prospectively enrolled adults participating in EPCTs at Massachusetts General Hospital from 04/2021-01/2023. We assessed QOL (Functional Assessment of Cancer Therapy-General, with subdomains: physical wellbeing [PWB], emotional wellbeing [EWB], social wellbeing [SWB], functional wellbeing [FWB]) and hope (Herth Hope Index) at time of EPCT enrollment, at 1 month (M1), and at 2 months (M2). We used descriptive statistics and regression models to describe changes and explore associations of patient-reported QOL and hope with patient factors (age, diagnosis, performance status) and clinical outcomes (time on trial [TOT], ED visits, and hospitalizations). Results: We enrolled 195 of 251 eligible patients (78% enrollment) and 192 completed surveys (98% response, median age: 63, 57% female, 94% metastatic cancer, ECOG 0 = 47% and ECOG 1 = 58%), 152 (78%) had M1 data, and 114 (59%) had M2 data evaluable. Most common cancer types were gastrointestinal (34%) and breast (20%). Over time, mean QOL scores improved (baseline [B/L] [75], M1 [76], M2 [76]), and mean hope scores were unchanged (B/L [39], M1 [39], M2 [39]). At M1, older age was associated with improved QOL change (B = 3.09, p = .031), EWB change (B = 0.94, p = .036), and increased hope (B = 1.22, p = .013). Female sex correlated with improved FWB (B = 1.15, p = .048) at M2. Head & neck cancer was associated with decreased EWB (B = -2.89, p = .010) at M2. Improved QOL at M2 was associated with longer TOT (HR = 0.97, p = .003). Improved PWB was associated with lower risk of ED visits (HR = 0.94, p = .011) and hospitalizations (HR = 0.95, p = .045) at M1, as well as longer TOT (HR = 0.94, p = .015) and lower risk of hospitalizations (HR = 0.93, p = .022) at M2. Improved EWB was associated with longer TOT at M1 (HR = 0.94, p = .001) and at M2 (HR = 0.89, p = .001). Improved FWB was associated with lower risk of hospitalizations (HR = 0.93, p = .023) at M1, as well as lower risk of hospitalizations (HR = 0.91, p = .043) and longer TOT (HR = 0.92, p = .016) at M2. We found no significant associations of changes in hope scores with clinical outcomes. Conclusions: This prospective study examined longitudinal changes in QOL and hope among EPCT participants. We described changes in QOL and hope scores from time of EPCT enrollment through 1- and 2-month follow-up and identified factors associated with these changes. Improvements in QOL over time predicted higher TOT and reduced healthcare utilization. Future studies should assess and address longitudinal changes in PROs to enhance trial experience and optimize clinical outcomes.