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Randomized Controlled Trial
. 2022 Jul 1;128 Suppl 13(Suppl 13):2623-2635.
doi: 10.1002/cncr.33965.

Patient navigation to address sociolegal barriers for patients with cancer: A comparative-effectiveness study

Affiliations
Randomized Controlled Trial

Patient navigation to address sociolegal barriers for patients with cancer: A comparative-effectiveness study

Tracy A Battaglia et al. Cancer. .

Abstract

Background: Sociolegal barriers to cancer care are defined as health-related social needs like affordable healthy housing, stable utility service, and food security that may be remedied by public policy, law, regulation, or programming. Legal support has not been studied in cancer care.

Methods: The authors conducted a randomized controlled trial of patients who had newly diagnosed cancer at a safety-net medical center in Boston from 2014 through 2017, comparing standard patient navigation versus enhanced navigation partnered with legal advocates to identify and address sociolegal barriers. English-speaking, Spanish-speaking, or Haitian Creole-speaking patients with breast and lung cancer were eligible within 30 days of diagnosis. The primary outcome was timely treatment within 90 days of diagnosis. Secondary outcomes included patient-reported outcomes (distress, cancer-related needs, and satisfaction with navigation) at baseline and at 6 months.

Results: In total, 201 patients with breast cancer and 19 with lung cancer enrolled (response rate, 78%). The mean patient age was 55 years, 51% of patients were Black and 22% were Hispanic, 20% spoke Spanish and 8% spoke Haitian Creole, 73% had public health insurance, 77% reported 1 or more perceived sociolegal barrier, and the most common were barriers to housing and employment. Ninety-six percent of participants with breast cancer and 73% of those with lung cancer initiated treatment within 90 days. No significant effect of enhanced navigation was observed on the receipt of timely treatment among participants with breast cancer (odds ratio, 0.88; 95% CI, 0.17-4.52) or among those with lung cancer (odds ratio, 4.00; 95% CI, 0.35-45.4). No differences in patient-reported outcomes were observed between treatment groups.

Conclusions: Navigation enhanced by access to legal consultation and support had no impact on timely treatment, patient distress, or patient needs. Although most patients reported sociolegal barriers, few required intensive legal services that could not be addressed by navigators.

Lay summary: In patients with cancer, the experience of sociolegal barriers to care, such as unstable housing, utility services, or food insecurity, is discussed. Addressing these barriers through legal information and assistance may improve care. This study compares standard patient navigation versus enhanced navigation partnered with legal advocates for patients with breast and lung cancers. Almost all patients in both navigation groups received timely care and also reported the same levels of distress, needs, and satisfaction with navigation. Although 75% of patients in the study had at least 1 sociolegal barrier identified, few required legal advocacy beyond what a navigator who received legal information and coaching could provide.

Keywords: breast cancer; cancer disparities; comparative effectiveness; health equity; lung cancer; patient navigation.

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Conflict of interest statement

Tracy A. Battaglia reports unpaid service as Chair of the National Navigation Roundtable outside the submitted work. JoHanna Flacks and Samantha J. Morton report personal fees from MLPB through a TSNE MissionWorks contract during the conduct of the study. The remaining authors made no disclosures.

Figures

Figure 1.
Figure 1.
This is a Consolidated Standards of Reporting Trials (CONSORT) diagram of total sample recruitment and enrollment for the Project SUPPORT comparative-effectiveness study (ClinicalTrials.gov identifier NCT02232074). CO indicates clinical outcome; PRO, patient-reported outcome.
Figure 2.
Figure 2.
The percentages of patients who had perceived sociolegal barriers at baseline and at 6 months are illustrated by cancer type.

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