Design and accrual of S1417CD: Development of a prospective financial impact assessment tool in patients with metastatic colorectal cancer (mCRC).

Abstract

TPS6652 Background: Few studies have assessed the financial impact of cancer diagnosis (dx) in diverse patients (pts) and caregivers (cgs) using objective and standard financial measures. S1417CD, led by the SWOG Cancer Research Network, is the first prospective cohort study assessing financial outcomes to be conducted in the NCI Community Oncology Research Program (NCORP). We present our experience with design and accrual. Methods: Pts age ≥ 18 within 120 days of mCRC dx were considered eligible and asked to identify a caregiver (cg) who could participate concurrently. The primary endpoint is incidence of treatment-related financial hardship, defined as ≥ 1 of the following: debt accrual, selling/refinancing home, ≥ 20% income decline, or borrowing money. Measures include 1) pt and cg surveys (baseline (BL), 3, 6, 9 and 12 months (mo)) assessing out-of-pocket spending, financial impacts, cg burden, and quality of life and 2) pt credit reports (BL, 6, and 12 mo). Linkage to records from TransUnion, a national credit agency, required pt social security number (SSN) and processes for batched credit report transfer via secure web portal. The accrual goal was n = 374 pts in 3 years. The study activated on Apr 1, 2016 and closed on Feb 1, 2019 after reaching its accrual goal. A total of 380 pts (median age 59.7 years) and 155 cgs enrolled (41% cg participation). Enrollment steadily increased during the study period; 56% enrolled in the last 12 mo. Credit data were not obtainable for 76 (20%) pts due to early death, lack of credit, or inability to match records. S1417CD, the first cooperative group led study assessing financial outcomes in the community setting, completed enrollment faster than anticipated. Required SSN collection was not a barrier to enrollment, which improved as sites became familiar with data security measures. Robust accrual to S1417CD demonstrates pts’ and cgs’ desire to improve understanding of financial toxicity and its solutions. Follow-up will conclude in 12 mo with results to follow. SWOG plans to launch a randomized study (S1912) assessing the impact of financial navigation on household finances, using credit data for primary endpoint assessment. Clinical Trials Registry Identifier NCI-2015-01885. Clinical trial information: NCT02728804.