A study of financial burdens (FB), quality of life and psychological distress among advanced cancer patients (ACP) in phase I trials
Introduction: FBs have been identified as a significant predictor of stress for cancer patients. These FB 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: 56 Phase I ACPs were interviewed at T1 and T2. For the total population: median age 62 (27-78y); 51% male; 100% married; 87% Ca; 69%> HS educ; 57% GI dx; 53% income <$65,000 yr, with 48% ACPs employed full/part-time; 56% retired. At T1, 82% of ACP reported medical cost concerns and 79% reported financial stress. Over time, for ACP, rates remained consistent with the exception of increased self-report re medical cost concerns at 85% respectively at T2. At T2, ACP who reported unexpected medical costs had higher STAI-S (31 ± 9 v 29 ±12, p=0.02) and CES-D scores (12 ± 11 v 10 ± 9, p=0.04). Full-time employed ACP had higher STAI-S scores (37 ± 12 v 33 ± 13, p=0.03) at T2 while self-reported retired ACP had higher STAI-T scores (39±15.7 v 36.0 ± 18 p=0.02). In regression analyses, ACP with medical costs concerns had poorer FACIT-Pal QOL over time. ACP qualitative responses re FB revealed salient themes: insurance coverage, medications, unexpected costs associated with research study participation, Medicare, bankruptcy, and worry re financial stability, transportation/lodging..
Conclusions: FBs are negatively associated with quality of life among clinical trial subjects in phase I trials. Oncology providers should discuss financial burdens with ACP in order to minimize distress and improve quality of life.