Associations between symptom burdens (SB) and expectations of benefit (EB) for advanced cancer patients (ACP) and spousal caregivers (SC) participating in phase I trials.

Abstract

e19595 Background: Terminally-ill ACP have been shown to have EB from experimental agents beyond what might be reasonably expected. The influence of disease severity and psychological factors, as measured by SB, on such EB is unknown. Methods: A convenience sample of ACP enrolling in phase I trials and SC were evaluated at baseline (T1) and one month later(T2) using a battery of standardized and/or validated assessments of SB including: cognition (MMSE); depression (CES-D); state-trait anxiety (STAI-S/T); posttraumatic growth (PTGI); quality of life/qol (FACIT-Pal); global health (SF-36); and martial adjustment (DAS). Data re participant EB were obtained utilizing Likert scores (1-10) measuring the likelihood of chemotherapy in: “stabilizing” (ST), “halting/shrinking” (HL), producing “remission”(PR), and “curing” (C) ACP’s cancer. Results: 104 participants (52 Phase I ACPs and 52 SC) were separately interviewed at T1 and T2. For the population as a whole, median age was 61y (28-78y); 50% male; 100% married; 87% Ca; 67% >HS educ; 51% GI dx. No associations were found between ACP SB (MMSE, CES-D, STAI-T, PTGI, FACIT-Pal, SF-36, DAS) and EB reported by ACPs. Regression analyses at T2 revealed negative associations between ACP SB state anxiety scores and the following ACP EB: ST, F (1, 51) = 6.52, p=.01; HL, F (1, 51) = 8.44, p< .01; and to PR of disease, F (1, 51) = 4.30, p=.04. At T2, for SC, negative associations were found between SC state anxiety and SC EB for: ST cancer, F (1, 51) = 6.52, p=.01, and HL, F (1, 51) = 3.02, p<.01. SC trait anxiety was also negatively associated with SC EB for ST the ACP’s cancer, F (1, 51) = 5.46, p=.02. Regression analyses revealed positive associations between SC martial satisfaction scores and the following SC EB: ST, F (1, 51) = 4.14, p=.04; HL, F (1, 51) = 4.46 p=.04; PR, F (1, 51) = 4.39, p=.04; C, F(1, 51) = 4.22, p=.03. Further positive associations were found between SC EB HL cancer and SC SF36 scores, F(1, 51) = 3.97, p=.03. No additional associations were found between SC SB (MMSE, CES-D) and SC EB. Conclusions: Our data indicate that several significant associations exist between ACP and SC SB and EB from Phase I trial participation.