Proactive costs of care (PCOC) intervention for newly diagnosed cancer patients: Results of a pilot trial.

354 Background: Financial toxicity (FT) affects at least one quarter of cancer patients starting treatment. One potential strategy to decrease FT is to provide upfront financial education to help patients manage costs of care. With extensive stakeholder input, we developed one such strategy, i.e., the Proactive Costs of Care (PCOC) intervention. Here we present results of its pilot trial. Methods: This randomized pilot study included newly diagnosed breast, gynecologic, and colorectal cancer patients at the University of Alabama at Birmingham. Participants were randomized to usual care (UC) or PCOC, i.e. a one-time session near treatment initiation with a trained lay educator to review cost-related informational materials, including: (1) “Insurance, Employment, and Financial Assistance Flyer” e.g., about insurance benefits, medical bills, federal job protection and supplemental income benefits; (2) “Cost Tracker” with a glossary of potential out-of-pocket (OOP) costs and space to track them; (3) “Cost Infographic” with cancer/stage-specific average OOP costs from published studies. The primary outcome was 6-month change in FT (Comprehensive Score for financial Toxicity [COST]; score 0-44, lower score worse FT, and FT positive if COST score < 26) and anxiety (Generalized Anxiety Disorder [GAD]-7, score 0-21, higher score higher anxiety, and moderate/severe anxiety if GAD score ≥10). Intention to treat (ITT) analyses were conducted using linear mixed-effects models for repeated measures. Results: The 60 randomized participants (29 PCOC, 31 UC) were on average 55 years old (SD 11), 49% Black, 43% married/partnered, 51% college educated, 52% with incomes ≥$60,000, 38% employed, and 76% privately insured. In the PCOC arm, most met with the educator (83%) and reviewed all materials (69%). Results are presented in Table 1. COST score improved significantly over 6 months for PCOC vs. UC group (p = 0.02). Conclusions: This educational, minimal touch, PCOC intervention has the potential to reduce FT. These results support the need for a larger study to demonstrate effectiveness of PCOC on FT. Clinical trial information: NCT05939440 . Outcome PCOC Baseline N = 29 PCOC6 months N = 23 UC BaselineN= 31 UC6 monthsN = 26 PCOC Estimated least squares change(6 months − baseline) a Mean(95% CI) P value UC Estimated least squares change(6 months − baseline) a Mean(95% CI) P value Absolute change differencePCOC vs UC a Mean(95% CI) P value COST score mean (SD) 20.8 (10.78) 24.0 (10.12) 23.4 (9.65) 22.6(10.61) 4.1(1.14, 7.09) 0.008 -0.78(-3.59, 2.02) 0.58 4.9 (0.81, 8.98) 0.020 FT % 58.6 60.9 58.1 50.0 OR 0.94(0.25, 3.47) 0.92 OR 0.68(0.20, 2.27) 0.52 OR 1.38(0.23, 8.19) 0.72 GAD-7 scoremean (SD) 6.3(6.00) 4.9(5.80) 5.3(5.16) 4.3 (4.33) -1.5(-3.45, 0.40) 0.12 -1.1(-2.95, 0.69) 0.22 -0.4(-3.04, 2.25) 0.77 Mod/sev anxiety % 27.6 17.4 22.6 15.4 OR 0.53(0.13, 2.19) 0.37 OR 0.60(0.15, 2.46) 0.47 OR 0.88(0.12, 6.53) 0.90 OR: Odds Ratio; a From linear mixed-effects models.