Financial burdens (FB), quality of life, and psychological distress among advanced cancer patients (ACP) in phase I trials and their spousal caregivers (SC).

Abstract

6117 Background: FBs have been identified as a significant predictor of stress for cancer patients and their caregivers/partners. FBs may indirectly affect the quality of life and psychological distress of clinical trial subjects, particularly those with advanced disease on Phase I trials. Methods: A convenience sample of ACP enrolling in phase I trials was assessed at baseline (T1) and one month (T2) using several measures including: depression (CES-D), state-trait anxiety (STAI-S/T), quality of life/qol (FACIT-Pal), and global health (SF-36). Data on FB were obtained via the questions of Ell (2008), querying subjects on: employment status, unexpected medical costs, concerns regarding wages (e.g. termination, use of sick time), and financial stress. Results: 104 subjects (52 Phase I ACPs and 52 SC) were separately interviewed at T1 and T2. For the total population: median age 61 (28-78y); 50% male; 100% married; 87% Ca; 67%> HS educ; 55% GI dx; 53% income <$65,000 yr, with45% ACPs employed full/part-time; 55% retired; 66% SC employed full/part-time with 34% retired. At T1, 82% of ACP reported medical cost concerns and 79% reported financial stress. For SC at T1, 69% reported medical costs concerns; 83% employed SC reported wage concerns; and 81% reported financial stress. For both ACP and SC, rates remained consistent with the exception of increased self-report re medical cost concerns at 85% and 72% respectively at T2. At T2, ACP who reported unexpected medical costs had higher STAI-S (31 ± 10 v 29 ±12, p=0.02) and CES-D scores (12 ± 11 v 10 ± 9, p=0.04). SC with self-reported financial stress had higher STAI-S anxiety (39 ± 17 v 35 ± 13, p=0.03) at T2. In regression analyses, ACP with medical costs concerns had poorer FACIT-Pal QOL over time. Also, SC with medical cost concerns at T2 was negatively associated with SF-36 scores. ACP and SC qualitative responses re FBs revealed salient themes: insurance coverage, unexpected costs associated with research study participation, Medicare, bankruptcy, and worry re financial stability after ACP death. Conclusions: FBs are negatively associated with quality of life among clinical trial subjects and SC in phase I trials.