Background: Disparities in cancer care outcomes for low-income, racial, and ethnic minorities are worsening in part due to barriers to timely care that occur outside the medical system. Responsive innovations are necessary to achieve equity in health outcomes. This trial was designed as an innovation in patient navigation that integrated 2 care delivery models—patient navigation and legal support for social barriers.
Objectives: To compare the impact of an established patient navigation program with partnership between patient navigation enhanced with legal support from MLPB (formerly known as Medical Legal Partnership | Boston) to identify unmet barriers to timely cancer treatment for low-income patients seeking cancer care services. With oversight from a Scientific Advisory Board and Patient Advisory Group, we designed a randomized controlled trial to compare outcomes among cancer patients enrolled in this enhanced patient navigation program featuring systematic screening and support for health-related social needs with standard patient navigation services. Project SUPPORT (Socio-Legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment) is a randomized, controlled, comparative effectiveness trial targeting low-income inner-city patients at risk for delays in care. Primary outcome measures include clinical outcomes (timely treatment, quality care) and patient-centered outcomes (ie, distress, perceived needs, patient satisfaction).
Discussion: Project SUPPORT offers a novel patient-centered approach to design and evaluate an innovation in cancer care delivery. The results of this study will evaluate the impact of enhanced patient navigation services with integrated legal support on both clinical care delivery and patient-reported outcomes.
Conclusion: Project SUPPORT is an innovation on patient navigation to address socio-legal barriers to treatment in cancer care.
Disparities in cancer outcomes have been a long-standing problem in part due to challenges in equitable and timely care. Evidence suggests that delays in cancer treatment are an important contributor to worsening disparities in clinical outcomes.1-3 A 2013 Institute of Medicine report4 identified ongoing challenges of our fragmented cancer care delivery system and called for more effort to foster patient engagement and development of a more coordinated delivery system. In response, the National Cancer Institute (NCI) Community Oncology Research Program was created to invest in community-based clinical research and includes a focus on cancer care delivery research (CCDR). This emerging field of CCDR5 is defined as “the multidisciplinary field of scientific investigation that studies how social factors, financing systems, organizational structures and processes, health technologies, and health care provider and patient behaviors affect access to cancer care, the quality and cost of cancer care, and ultimately the health and well-being of cancer patients and survivors.”6
Patient navigation is one type of innovation in cancer care delivery designed to alleviate barriers to timely cancer care. In 2005, the NCI invested in a national multisite intervention study, the Patient Navigation Research Program (PNRP),7 a rigorous evaluation of patient navigation provided to vulnerable populations at the time of an abnormal cancer screening test or new cancer diagnosis. The results demonstrate that the overall benefit of navigation is modest and most impactful for those with the longest delays in care.8 These studies also document that delays persist despite navigation for certain populations, namely those with multiple barriers, specifically barriers related to social determinants of health that remain unaddressed.9-11
Using national PNRP data, we categorized the barriers into 2 groups: (1) socio-legal barriers, and (2) other barriers (Table 1). Socio-legal barriers refer to barriers of social problems related to meeting life’s most basic needs (ie, housing, employment, disability) that are addressed by existing public policy, law, regulation, and programming and are thus potentially remedied through legal advocacy.12 These factors are now well-recognized contributors to poor health outcomes across patient populations for many chronic diseases, including cancer,13 yet these needs often are invisible to the healthcare team.14 More recently referred to as health-related social needs,15 socio-legal barriers include housing or food insecurity, domestic violence, and financial challenges due to underemployment.16,17 One paradigm for classification of these needs is the I-HELP framework (Income and Insurance Supports, Housing & Utilities, Employment & Education, Legal Status/Immigration, and Personal and Family Safety).18 We found those with socio-legal barriers were less likely to have timely resolution of diagnostic care.19 These findings are supported by other navigation studies that found poor patient outcomes are attributable to unmet housing, insurance, and financial needs.20 A subsequent cross-sectional survey of patients seeking cancer care services at our urban safety net medical center documented that 77% report 1 or more socio-legal concerns.21
This collective evidence led to our hypothesis that the modest effect of navigation in our low-income population may be related to the presence of these complex socio-legal barriers to care. Some remedies to these barriers remain external to the current healthcare system, which standard-of-care patient navigators were not trained to identify or to address. In response to this persistent delivery gap, we partnered with a legal advocacy program and a diverse group of community stakeholders to design a cancer care delivery trial that will test an innovation in patient navigation services. Here we report the methods for design and implementation of Project SUPPORT (Socio-Legal Services for Underserved Populations Through Patient Navigation to Optimize Resources During Treatment), a randomized clinical trial comparing patient navigation enhanced by socio-legal support services with conventional patient navigation.
Material and Methods
Project SUPPORT utilized a community-engaged approach to conduct a scientifically rigorous, randomized, controlled comparative effectiveness trial to test the hypothesis that the addition of screening for and addressing socio-legal barriers with support from legal advocates would improve clinical and patient-reported outcomes for vulnerable cancer patients receiving standard-of-care patient navigation. This study is approved by the Boston University Medical Center Institutional Review Board and is registered on ClinicalTrials.gov (NCT02232074).
A unique aspect in the development of Project SUPPORT was the incorporation of multiple stakeholders. To ensure comprehensive stakeholder engagement, we utilized Concannon and colleagues’ 7P framework22 (Patients and the Public, Providers, Purchasers, Payers, Policy Makers, Product Makers, Principal Investigators) as an essential component of our trial. This framework guided a community-engaged research approach to ensure both our responsiveness to the community and the rigor of our scientific methods. Collectively, these stakeholders provide longitudinal guidance on patient perspectives, intervention development, review of the literature, scientific methods, study design, outcome metrics, and strategy for recruitment and retention.
As illustrated in the Figure, Project SUPPORT is a randomized controlled trial testing the benefit of patient navigation enhanced with legal support to address socio-legal barriers compared with standard patient navigation services on both clinical and patient-reported outcomes.
Boston Medical Center (BMC) is the largest safety net medical center in New England, servicing the region’s most vulnerable populations. More than 50% of patients have an annual income of less than $20,420; nearly 70% are racial/ethnic minorities; and more than 50% are public health insurance recipients. As a Commission on Cancer (CoC)-accredited program and former site of the NCI PNRP, navigation services are a standard service to support our patients.
The study target population is newly diagnosed adult patients with breast or lung cancer, the 2 disease sites with the longest documented delays in care at BMC, and evidence that delays affect survival.23,24 Eligibility for inclusion include adult patients 18 years and older with newly diagnosed breast or lung cancer who speak English, Spanish, or Haitian Creole (the 3 most common spoken languages). Exclusion criteria include: (1) more than 30 days since the date of the cancer diagnosis (to ensure the opportunity to have an impact on the outcome), (2) a history of any other cancer diagnosis within the past 5 years, or (3) cognitive issues that would impede the participant from interacting directly with a patient navigator.
Recruitment and Randomization
Potentially eligible participants are identified through (1) review of pathology reports for cancer biopsies, (2) multidisciplinary tumor boards, and (3) review of oncology provider schedules. Once participants are identified as eligible for this study, a language congruent research assistant explains the study and obtains informed consent. At the time of enrollment, participants are randomized into 1 of the 2 groups: standard patient navigation or intervention patient navigation. Prior to study start-up, our statistician conducted the randomization procedure using the statistical software package R.25 Patients are automatically randomized by research assistants using the randomization scheme created, which is embedded into the REDCap data management system. Patients are randomized separately within the lung and breast cancer populations.
Control Arm: Standard Patient Navigation
Participants randomized into the control group receive standard patient navigation services consistent with the PNRP model. The control patient navigator is a lay individual integrated into the cancer care team who has received standard training in navigation services at BMC. Navigation services are provided in response to individual patient needs such as transportation needs and appointment reminders.
Intervention Arm: Intervention Patient Navigation
The intervention patient navigator (IPN) is a lay individual who has completed standard navigation training in addition to training through MLPB focused on problem-solving strategies on disability, employment, and housing needs. These half-day MLPB trainings focused on using study-specific tools to screen for social determinants of health, common barriers to accessing health-promoting benefits and services available to individuals and families, the range of remedies available to patients under current law and public policy, and problem-solving strategies for a navigator to understand when to involve a legal expert.
The design of our intervention focuses on the enhancement of patient navigation with the support of a legal advocacy program. We designed this innovation together with MLPB, which since 1993 has been providing services to the Pediatrics Department at BMC (and more recently to other patient populations within and outside the institution). Medical-legal partnerships are structured collaborations between public interest lawyers and healthcare teams designed to address social determinants of health that (1) implicate laws and policies, (2) are known to contribute to substantial disparities in health outcomes, and (3) are amenable to legal problem-solving.26 Currently, there are 294 medical-legal partnerships in healthcare institutions across 46 states.
For participants randomized into the intervention group, the IPN administers 3 detailed screening tools related to Housing & Utilities, Disability Benefits, and Employment to systematically assess for socio-legal barriers to health and care. The IPN then consults with MLPB about the screening results to determine if the Level of Legal Need (LLN) could be addressed (1) through simple dissemination of information to the patient, (2) through more complex problem-solving tasks that the patient could undertake in collaboration with the navigator, and/or (3) through direct legal assistance to the patient by a lawyer. These classifications are detailed in Table 2. Depending on the LLN, MLPB and the IPN discuss their respective roles for each case, develop a collaborative action plan for how to support the patient in addressing the barriers and immediately proceed to implementing the plan.
Three months after enrollment, the IPN again administers (with patients randomized to the intervention) the detailed Housing & Utilities, Disability Benefits, and Employment screens to identify any new risks or needs. Throughout study participation, continuous MLPB and IPN consultation is conducted, and LLN status is modulated whenever new barriers are identified. Two standing meetings support this continuous consultation: MLPB and the IPN meet bimonthly in person to discuss all active cases, and separately MLPB conducts weekly internal meetings among its attorneys to triage complex matters, including those arising from this study. The IPN had access to MLPB at any time, as needed, by phone or e-mail.
Data sources include surveys for patient-reported outcomes and the electronic health records for clinical outcomes. Data collection includes baseline surveys, with subsequent surveys administered at 3, 6, and 12 months after enrollment. Surveys are administered in person or over the phone by trained research assistants who speak the patient’s primary language. Answers are entered into the digital data management application REDCap.27 Hosted at Boston University, REDCap is a secure, web-based application that supports data management for research studies.
Data abstraction from the electronic medical records for clinical outcomes are conducted at 6 and 12 months after cancer diagnosis. A chart abstraction tool is used by trained research assistants and independently verified by a second research assistant, and data are recorded into REDCap. The data manager and co-investigator adjudicate discordant results. These variables include the primary outcome (time to first treatment), secondary outcomes (treatment quality metrics), and other treatment-related information such as tumor characteristics and staging.
Definition of Measures and Outcomes
See Table 3.
Clinically Relevant Outcomes
Our primary outcome is the binary indicator of timely initiation of cancer treatment, defined as receipt of first treatment within 90 days from diagnosis. Time to initiation of treatment and quality of cancer care are secondary outcomes of interest. Time to initiation of treatment is a continuous measure in the number of days from diagnosis to receipt of first treatment.
Quality cancer care outcomes are based on national quality care guidelines and recommendations from organizations such as the National Comprehensive Cancer Network28 and the CoC program from the American College of Surgeons.29 Examples of these outcomes include receipt of chemotherapy within 120 days and receipt of adjuvant endocrine therapy within 365 days of diagnosis.
Patient Reported Outcomes
Four different patient-reported outcomes will be measured as part of the study: (1) distress using the Distress Thermometer,30 (2) self-efficacy using Communication and Attitudinal Self-Efficacy Scale for cancer,31 (3) perceived needs using the Cancer Needs Distress Inventory,32 and (4) patient satisfaction using Patient Satisfaction with Interpersonal Relationship with Navigator.33
All study participants complete a 25-item I-HELP survey that identifies participant concerns across the 5 I-HELP categories (Income and Insurance Supports, Housing & Utilities, Education & Employment, Legal Status/Immigration, and Personal and Family Safety). A positive response to any of the 25 questions deems the participant as screening positive for a socio-legal concern. This positive response was required to be included in the final analytic sample. Implementation measures to assess fidelity to the intervention protocol include the detailed legal screen, reported LLN, and contact with patient navigators. To capture utilization of healthcare services, we are monitoring missed appointments in each group.
Enrollment of recently diagnosed breast and lung cancer patients occurred from February 2013 through August 2017. A total of 305 patients enrolled, 273 with breast cancer and 32 with lung cancer. Of the patients enrolled, 72% reported at least 1 socio-legal concern at baseline and will define our analytic sample (N = 220). The mean age was 55 years, with the majority being non-white (51% black, 22% Hispanic); 20% spoke Spanish, and 8.2% Haitian Creole; 73.6% had public health insurance (Table 4).
Our analytic sample will only include those 220 patients who screen positive on the I-HELP survey at baseline. Univariate logistic regression models will compare the proportion of patients with timely initiation of treatment across study groups, and multivariate logistic regression models will adjust for the influence of age, race/ethnicity, cancer site, stage of disease, and other covariates that may have a significant effect on the outcome and may be unbalanced across the 2 study groups. To examine heterogeneity in intervention effect, exploratory analyses using multiple logistic regression interaction models will examine whether the effect of MLPB-supported navigation varies by 3 covariates of interest: (1) patient race/ethnicity, (2) cancer site, and (3) burden of health-related social needs (number and type of socio-legal barriers).
Survival analysis will be conducted as a secondary clinical outcome to examine if differences exist between treatment groups in the time taken to timely initiation of care. Study groups will also be compared on the time to initiation of primary cancer treatment (the number of days from diagnosis to start of treatment) through Kaplan-Meier survival curves (unadjusted analyses) and Cox proportional hazards regression models controlling for cancer site and other covariates (adjusted analysis).
Patient-reported outcomes will be measured using summation scores with established subscales. Multiple linear regression models adjusting for baseline scores of the patient-reported outcome will be used to compare study groups on changes in distress, self-efficacy, satisfaction with navigation, and physical and psychosocial needs during cancer treatment. Covariates in each model will include age, race/ethnicity, stage of disease, and other covariates that may have a significant effect on the outcome and may be unbalanced across the 2 study groups. Outcomes are measured at many time points, and longitudinal regression mixed models will be used to explore effects and changes over the study period.
Institutional registry data suggest that approximately 76% of navigated patients receive timely initiation of care, defined as within 90 days from date of diagnosis. With 187 patients randomized to each of the 2 study groups, our study has >80% power of detecting an advantage to navigation enhanced by a medical-legal partnership, if the enhanced intervention raises the percentage of participants receiving timely initiation of care (our primary outcome) from 76% to 90.5% (testing at the two-tailed 5% significance level). The sample size allows for a 10% dropout rate over the course of the study.
In response to evidence of persistent delays in cancer care despite patient navigation, we sought to design a prospective longitudinal clinical trial that would target unaddressed barriers to cancer care for underserved cancer patients. Project SUPPORT is a randomized, controlled, comparative effectiveness trial designed to address root causes of outcome disparities in cancer care among a vulnerable patient population by addressing socio-legal barriers—social, economic, and environmental—to care with remedies embedded in existing law and public policy. This study protocol was established with oversight from a scientific and patient advisory group to maximize scientific rigor as well as patient relevance. This study will test how patient navigation services enhanced with legal support may improve timely delivery of cancer care and patient-reported outcomes for a largely low-income minority patient population at high risk for cancer disparities.
Project SUPPORT is part of a growing national focus34 on detecting, triaging, and addressing health-related social needs. This is the first study to integrate 2 emerging strategies in healthcare delivery (patient navigation and medical-legal partnership) that target socio-legal barriers identified by low-income populations at risk for poor health outcomes. By testing a patient navigation program enhanced with legal support, Project SUPPORT pilots a delivery innovation that (1) identifies unmet health-related social needs, (2) utilizes existing programs, and (3) links individuals with community services to reduce the known disparities in cancer outcomes for vulnerable populations. Our study findings will address the growing need for comparative effectiveness studies to inform best practices for oncology patient navigation programs.35
The current national agenda to improve healthcare for all is exemplified by sweeping changes in the era of the Affordable Care Act. For example, the Centers for Medicare & Medicaid Services (CMS) Innovation Center reflects a distinct focus on social determinants of health. The CMS Accountable Health Communities (AHC) model15 has identified health-related social needs as social factors that contribute to barriers in healthcare that may have remedies through enhanced clinical and community partnerships. Specific criteria of the AHC model “will promote clinical-community collaboration through (1) Screening of community-dwelling beneficiaries to identify certain unmet health-related social needs, (2) referral of community-dwelling beneficiaries to increase awareness of community services, (3) provision of navigation services to assist high-risk community-dwelling beneficiaries with accessing community services, and (4) encouragement of alignment between clinical and community services to ensure that community services are available and responsive to the needs of community-dwelling beneficiaries.”15 Our structured partnership between a patient navigator (providing medical model services) and MLPB (public interest lawyer training, coaching, and problem-solving support for the navigator and patients) aligns directly with addressing CMS-defined health-related social needs.
A limitation of Project SUPPORT is that this single-institution study will have limited generalizability. On the other hand, socio-legal barriers exist within larger contexts, including local/regional/state resource environments. Community-specific demands and social context are not easily generalizable to other geographic locations. But, testing the efficacy of this intervention in our population will be instrumental for future dissemination studies. We will be collecting implementation data to support future potential dissemination in other settings. The implications for this dissemination are vast given the network of both patient navigation and medical-legal partnership programs operating across the United States.
Project SUPPORT is gathering novel data that will improve our understanding of how health-related social needs affect our patients in addition to testing the efficacy of an innovative patient navigation intervention on timely cancer care.
Research Support: PCORI (AD-1304-6272), ACS (RSG-13-368-01-CPPB), the Boston Medical Center Carter Disparities Fund. Dr. Gunn’s effort was supported in part by the National Cancer Institute (1K07CA221899-01).
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- Menashe I, Anderson WF, Jatoi I, Rosenberg PS. Underlying causes of the black–white racial disparity in breast cancer mortality: a population-based analysis. J Natl Cancer Inst. 2009;101:993-1000.
- Institute of Medicine. Levit LA, Ganz PA, Nass S, et al, eds. Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis. Washington, DC: National Academies Press; 2013.
- Kent EE, Mitchell SA, Castro KM, et al. Cancer care delivery research: building the evidence base to support practice change in community oncology. J Clin Oncol. 2015;33:2705-2711.
- National Cancer Institute Community Oncology Research Program (NCORP). https://ncorp.cancer.gov. 2016.
- Freund KM, Battaglia TA, Calhoun E, et al. National Cancer Institute Patient Navigation Research Program: methods, protocol, and measures. Cancer. 2008;113:3391-3399.
- Freund KM, Battaglia TA, Calhoun E, et al. Impact of patient navigation on timely cancer care: the Patient Navigation Research Program. J Natl Cancer Inst. 2014;106:dju115.
- Ramachandran A, Snyder FR, Katz ML, et al. Barriers to health care contribute to delays in follow-up among women with abnormal cancer screening: data from the Patient Navigation Research Program. Cancer. 2015;121:4016-4024.
- Ramachandran A, Freund KM, Bak SM, et al. Multiple barriers delay care among women with abnormal cancer screening despite patient navigation. J Womens Health (Larchmt). 2015;24:30-36.
- Hendren S, Chin N, Fisher S, et al. Patients’ barriers to receipt of cancer care, and factors associated with needing more assistance from a patient navigator. J Natl Med Assoc. 2011;103:701-710.
- World Health Organization. Social determinants of health. www.who.int/social_determinants/en. 2016.
- Clark CR, Ommerborn MJ, Coull B, et al. Income inequities and Medicaid expansion are related to racial and ethnic disparities in delayed or forgone care due to cost. Med Care. 2016;54:555-561.
- Bikson K, McGuire J, Blue-Howells J, Seldin-Sommer L. Psychosocial problems in primary care: patient and provider perceptions. Soc Work Health Care. 2009;48:736-749.
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- Berkowitz SA, Seligman HK, Choudhry NK. Treat or eat: food insecurity, cost-related medication underuse, and unmet needs. Am J Med. 2014;127:303-310.
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- Primeau SW, Freund KM, Ramachandran A, et al. Social service barriers delay care among women with abnormal cancer screening. J Gen Intern Med. 2014;29:169-175.
- Rodday AM, Parsons SK, Snyder F, et al. Impact of patient navigation in eliminating economic disparities in cancer care. Cancer. 2015;121:4025-4034.
- Ko NY, Battaglia TA, Gupta-Lawrence R, et al. Burden of socio-legal concerns among vulnerable patients seeking cancer care services at an urban safety-net hospital: a cross-sectional survey. BMC Health Serv Res. 2016;16:196.
- Concannon TW, Meissner P, Grunbaum JA, et al. A new taxonomy for stakeholder engagement in patient-centered outcomes research. J Gen Intern Med. 2012;27:985-991.
- Bleicher RJ, Ruth K, Sigurdson ER, et al. Time to surgery and breast cancer survival in the United States. JAMA Oncol. 2016;2:330-339.
- Gomez DR, Liao KP, Swisher SG, et al. Time to treatment as a quality metric in lung cancer: staging studies, time to treatment, and patient survival. Radiother Oncol. 2015;115:257-263.
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- Sandel M, Hansen M, Kahn R, et al. Medical-legal partnerships: transforming primary care by addressing the legal needs of vulnerable populations. Health Aff (Millwood). 2010;29:1697-1705.
- Harris PA, Taylor R, Thielke R, et al. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42:377-381.
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- Commission on Cancer. Cancer Program Standards (2016 Edition). www.facs.org/quality-programs/cancer/coc/standards. 2016.
- Akizuki N, Yamawaki S, Akechi T, et al. Development of an Impact Thermometer for use in combination with the Distress Thermometer as a brief screening tool for adjustment disorders and/or major depression in cancer patients. J Pain Symptom Manage. 2005;29:91-99.
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- Lowery AE, Greenberg MA, Foster SL, et al. Validation of a needs-‐based biopsychosocial distress instrument for cancer patients. Psychooncology. 2012;21:1099-1106.
- Jean Pierre P, Fiscella K, Winters PC, et al. Cross cultural validation of a Patient Satisfaction with Interpersonal Relationship with Navigator measure: a multi-site patient navigation research study. Psychooncology. 2012;21:1309-1315.
- Alley DE, Asomugha CN, Conway PH, Sanghavi DM. Accountable health communities—addressing social needs through Medicare and Medicaid. N Engl J Med. 2016;374:8-11.
- National Academies of Sciences, Engineering, and Medicine. Establishing Effective Patient Navigation Programs in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press; 2018.