Accelerating cancer clinical trial recruitment through a financial reimbursement program integrated with patient navigation: an interrupted time series analysis

Hala T Borno; Tracy Kuo Lin; Sylvia Zhang; Andrea Skafel; Alyssa Lalanne; Dana Dornsife; Robert Johnson; Darcy Spicer; Eric J Small; Kim F Rhoads

doi:10.1016/j.jcpo.2021.100305

Accelerating cancer clinical trial recruitment through a financial reimbursement program integrated with patient navigation: an interrupted time series analysis

J Cancer Policy. 2021 Dec:30:100305. doi: 10.1016/j.jcpo.2021.100305. Epub 2021 Sep 4.

Authors

Affiliations

¹ Department of Medicine, Division of Hematology/Oncology, University of California San Francisco, San Francisco, CA, USA; Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA. Electronic address: hala.borno@ucsf.edu.
² Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA; Institute for Health & Aging, Department of Social and Behavioral Sciences, University of California San Francisco, San Francisco, CA, USA.
³ Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.
⁴ Lazarex Cancer Foundation, Danville, CA, USA.
⁵ Department of Medicine, Division of Hematology/Oncology, University of Southern California, Los Angeles, CA, USA.
⁶ Department of Medicine, Division of Hematology/Oncology, University of California San Francisco, San Francisco, CA, USA; Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA.
⁷ Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, USA; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.

PMID: 35559801
DOI: 10.1016/j.jcpo.2021.100305

Abstract

Background: Cancer treatment clinical trials face major challenges with patient recruitment. Strategies to address patient indirect costs associated with clinical trial participation may accelerate accrual overall. The current study examined the effect of the IMproving Patient Access to Clinical Trials (IMPACT) intervention on patient accrual to cancer treatment clinical trials at an academic medical center. The IMPACT intervention was an onsite patient navigator combined with a financial reimbursement program to address patient out of pocket costs and began on September 2018.

Methods: This analysis measured frequency of patient enrollment in cancer treatment clinical trials and available cancer treatment clinical trials per month between January 1, 2016 and March 31, 2020. An interrupted time-series analysis (ITSA) was conducted to estimate changes in patient enrollment attributable to the IMPACT intervention.

Results: During the study period, a mean of 69 patients enrolled in clinical trials per month (standard deviation (SD = 13), with 27 (SD = 7) in early phase vs 41 (SD = 12) in late phase clinical trials. The number of available clinical trials per month was 51 (SD = 2) overall, with 23 (SD = 1) in early phase vs 28 (SD = 1) in late phase context. A total of 3470 patients were enrolled in cancer treatment clinical trials during the evaluated time period, the majority of whom were men (1895, 55 %) and racially white (2267, 65 %). A statistically significant increase in the number of patients accrued as compared to the pre-intervention trend was observed; with approximately 1 additional patient accrued per month, with a larger effect on increase patient accrual for late phase clinical trials.

Discussion: This study observed that the IMPACT intervention accelerated clinical trial recruitment, especially among late phase clinical trials. Future research will examine strategies to leverage this infrastructure to optimize recruitment among underrepresented patients.

Policy summary: To improve clinical trial recruitment and ensure that trial results are representative of a diverse population it is critical for health policies consider patient out-of-pocket costs and potential reimbursement to alleviate financial burden associated with clinical trial participation. Furthermore, policies for facilitating clinical trial recruitment and participant retention should budget for and incorporate a navigation component to assist patients who may not be familiar with the healthcare system and available financial assistance.

Keywords: Cancer; Clinical trial participation; Financial toxicity; Patient navigation.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Female
Health Expenditures
Humans
Interrupted Time Series Analysis
Male
Neoplasms* / therapy
Patient Navigation*
Patient Selection