The future of oncology care requires integration of patient engagement and equity into practice

Cancer is a global and national public health challenge, taking an estimated 10 million lives and costing more than US$1 trillion annually [1]. Cancer is also a case study in health disparities – the burden of who gets sick, who gets treated and who survives is distributed unevenly, with the greatest suffering experienced by low- and middle-income countries worldwide [1] and by communities of color in the USA [2].

Structural racism has its roots in the trans-Atlantic slave trade and spreads its branches into every aspect of daily living for black communities in the USA, including health care [3]. ‘Structural racism’ as a term describes how societal practices reinforce racial discrimination through ‘mutually reinforcing systems,’ with the consequence of systemically proliferating ‘discriminatory beliefs, values, and distribution of resources’ [4]. Recognition of its impact is not new. In 1946, President Harry Truman signed the Hill–Burton Act into law, which was a monumental step forward in addressing unequal care and treatment in the USA [5]. In 2003, the Institute of Medicine report ‘Unequal Treatment – Confronting Racial and Ethnic Disparities in Health Care’ highlighted that legacy of racism in healthcare in the USA by cataloging how racial and ethnic minorities are less likely to receive preventive medical care than whites — and receive lower-quality care once diagnosed [6].

Systemic transformation in equitable cancer care requires an acknowledgment of structural racism as a root cause of disparities [3] through embedded structures that determine eligibility and that route people to a given course of care, such as cancer risk assessment models, screening guidelines, treatment center locations, instrument calibration formulas, outcome measures and endpoints. A shared vision for equitable, high-quality care integrates patient engagement practices and antiracism strategies with health information technologies to correct these structural inequities and address cancer risk factors related to biology, patient behavior and timely access to care across populations. Further, systemic transformation requires that individuals and institutions alike accept accountability for our role in the system and commit to driving change through personal actions.

This article describes these opportunities and the actions that we can all take right now to begin dismantling structural racism in cancer and to reimagine a system that delivers equitable quality care that results in better outcomes across populations. Although our discussion describes structural disparities specific to the US black experience, we hope that the perspectives and approaches offered may also inform ways to better serve other marginalized populations living with cancer, including LGBTQ communities and people with disabilities.

Five priorities for transforming equitable cancer care over the next 10 years

The Cancer Continuum of Care extends through screening, diagnosis, treatment (including clinical research participation) and survivorship; there are opportunities within and across these domains to transform care for the populations experiencing the poorest outcomes [7].

Accelerate ‘stage shift’ by developing & adopting emerging early detection technologies & corresponding treatment options in early-stage cancer clinical care and research

Only five cancer types have established and recommended screenings: breast, cervical, colorectal, prostate and lung cancer [8]. For cancer types without screening modalities, such as esophageal, pancreatic, kidney, ovarian and stomach, emerging technologies for multicancer early detection (MCED) offer the promise of earlier detection, diagnosis and treatment. Via a blood draw, these tests can detect multiple types of cancers before individuals become symptomatic. Racial and ethnic minorities in the US are among those diagnosed with unscreened cancers at later stages compared to non-Hispanic whites. Continued development, adoption and access to these technologies may lead to better and more equitable cancer outcomes for these populations.

There are no guarantees, however. Risk assessment models, such as the GAIL model for metastatic breast cancer, need continuous improvement to end exclusion of nonwhite populations [9] from screening and care pathways. Incentives are needed to promote the continued development of early detection technologies [8] as well as to measure the impact of early detection and screening for diverse populations [10]. Relevant clinical guidelines, recommendations, new treatment options and payer coverage must keep pace with MCED technology development, with particular focus on the needs of minority communities [8]. Trusted patient and community advocates can help in the cocreation of health literate and culturally competent community outreach and education materials about cancer risk, prevention and early detection [2,8].

Integrate community oncology settings in clinical trials networks

Community oncology practices offer a multidisciplinary team approach to treat cancer patients locally; these practices are not typically part of a larger hospital system or academic research center and are located in urban as well as rural geographies. Approximately 55% of cancer patients in the US are cared for in community oncology practices [11].

Engaging community oncology practices in cancer clinical research can be part of a strategy to improve care outcomes as measured by guideline adherence [12]. Oncology experts and regulatory officials increasingly recognize the role that community oncology can play in ensuring that cancer research participant populations represent the diversity of the patient population and generate generalizable data. US FDA drug development director Janet Woodcock advocates for integrating community oncology into a ‘national clinical trial capacity stockpile,’ a strategy that would make clinical trials available to patients regardless of their proximity to the academic medical centers where most clinical research is conducted [13].

In parallel, the American Society of Clinical Oncology (ASCO) is partnering with the Association of Community Cancer Centers (ACCC) to help community cancer centers assess and build their capacity to offer clinical trial options to patient populations who are traditionally underrepresented in research. The initial ASCO–ACCC initiative begins with a pilot project testing tools such as a diversity site assessment tool and implicit bias training to determine the outcomes related to ‘structural and procedural factors’ at a site that may influence clinical trial screening and participation rates [14].

Adopt, study & publish impact of expanding eligibility criteria in clinical trials

In 2016, ASCO and Friends of Cancer Research (FOCR) began a joint effort to expand inclusion criteria for cancer clinical trials, recognizing that existing exclusion criteria may be disproportionately leaving out cancer patients of color, women and the elderly (75+) and inhibiting the development of representative data [15]. Facilitating multistakeholder working groups including clinicians, patient advocates, drug development manufacturers and researchers, ASCO-FOCR issued consensus recommendations and guidance documents related to multiple topics in cancer protocol development: brain metastases, virus infections (HIV/AIDS, hepatitis B, hepatitis C), organ dysfunction and prior and concurrent malignancies, and minimum age for enrollment. Subsequent recommendations now include washout periods and concomitant medications, performance status, prior therapies, laboratory reference ranges and testing intervals [15].

The collaboration encourages researchers to study and publish the impact of adopting these guidelines on participation demographics and patient access to research options through real-world analysis. In one study of non-small-cell lung cancer (NSCLC), researchers found that adopting the new criteria in three areas – brain metastases, no other malignancies and creatinine clearance – nearly doubled the pool of eligible participants compared with traditional criteria, in particular allowing more women and elderly patients to participate as well as those with stage IV NSCLC [16].

Adopt digital endpoints to accelerate decentralized clinical trials

The onset of COVID-19 has jump-started interest in and innovation for decentralized clinical trials. Decentralized clinical trials allow for some study-related activities and monitoring to take place remotely, away from the investigator site, through the use of ‘administrative and technological support; virtual platforms (including telemedicine), and (patient) in-home services’ [17]. Since March 2020, the FDA has issued guidance allowing the use of ‘alternative methods’ to replace on-site study visits for safety assessments to ensure the safety of clinical trial participants and staff during the conduct of a clinical trial [18].

By reducing access burdens for patients and enabling more clinicians to participate, decentralized clinical trials offer promise in expanding and diversifying clinical research participation [17]. The development and adoption of digital clinical measures and endpoints is necessary for decentralized clinical trials to achieve this promise [19]. Digital clinical measures and endpoints are achieved when digital sensors are used to transmit signals from patients on factors related to their clinical care, such as monitoring performance status or vital signs. The Digital Medicine Society (DiME), a professional organization for experts in digital medicine, reports that there are no digital measures or endpoints being used in industry-sponsored clinical trials for oncology medical products among the 166 unique digital endpoints contained in its library, or among the seven under evaluation by the FDA [20].

Consensus-defined best practices in clinical care, technology development and operations exist to support the development of digital endpoints to enable safe and equitable delivery of quality oncology care outside of the clinic or investigator site [20]. The opportunity is now for sponsors to invest in the development of these endpoints and implement them in oncology clinical trials [19].

Focus institutions on inclusion in the workplace, professional associations & in operational practices

The personal bond between patients and their providers is an essential element to individual patient engagement [21]. Research suggests that people experience better care when they share a race, ethnicity and/or cultural identity with their providers [22]. In 2020, a team of researchers from Penn Medicine published results of a large survey concluding that patients who shared the same racial or ethnic background as their physician were more likely to give the maximum patient rating score [23].

Oncology institutions, including medical practices, health systems, professional associations, advocacy organizations and the medical products industry, have expressed a commitment to equity, particularly over the past year in the US, where the disparities associated with COVID-19 and the deadly consequences of overpolicing have become impossible to overlook and accept.

Oncology institutions have work to do when it comes to representation among the professional ranks in the USA. In 2019, Dr. Robert Winn of the Massey Cancer Center at Virginia Commonwealth University became only the second Black director of one of the National Cancer Institute’s 71 federally designated cancer centers since the program began 50 years ago [24]. Other statistics confirm this disparity: studies suggest that nearly 60% of the oncology workforce is white [25]; female physicians of color are less represented than white males in oncology practice and in academic leadership positions [26] and in cancer research grants [27].

A vision for patient-centered, antiracist cancer care

An antiracist, patient-centered system for cancer care relies on the interdependence of the patient engagement, antiracism and health information technology (health IT) across four patient population levels: Patient, Practice (Organization), Population and Public. Activities related to patient engagement and inclusion at each level facilitate and mutually reinforce interventions to support the collection, analysis and use of cancer care and research data to inform guidelines, influence policies and ultimately improve care and outcomes, as illustrated in the health IT interoperability roadmap (Figure 1) [28].

Patient

Activities at the patient level revolve around strategies and tools to empower an individual patient, support individual behavior modification, elicit preferences, surface implicit bias and facilitate shared decision-making and document this information in the electronic patient record. Decision support materials are an example of an intervention at this level. Researchers may redesign traditional clinical trial recruitment materials to offer decision support to a patient during informed consent. These materials contain essential information specified by individual patients to help them decide with their providers if a given trial option is right for them [29].

Practice (organization)

This level relates to an individual practice or other health care organization. Strategies and tools at this level support organizational culture and operational practices, particularly as they relate to patient care coordination and health system referrals. They may also include nonmedical business functions that affect a community's social determinants of health, such as workforce hiring and compensation, budgeting, facilities placement and operations and procurement practices. An organization may establish a community and/or patient advisory council to inform the organization’s protocols, policies and procedures for developing and delivering care. Cancer care success factors include investment in facilities or collaborations that allow accuracy in molecular profiling and precision diagnostics [7,21] as well as in interoperable health IT systems, such as electronic medical records synced with clinical trial management systems, combined with opt-in features in the patient portal for patients to indicate preferences [21]. Further operational success factors include mechanisms for collecting and reporting data on the patient race and ethnicity when assessing patient engagement initiatives [21] and employing staff and community volunteers as patient navigators [21].

Population

Stakeholders identify the cancer patient population by disease, geography and demographic factors. Data are collected and analyzed to see the population in terms of aggregated disease status and health outcomes, comorbidities and health care utilization of treatments and services, including health care setting and health insurance. The disparate, negative consequences of structural racism and policies, such as neighborhood red-lining, on community health become apparent.

Interventions at this level relate to engaging patients and caregivers in cancer disease registries, clinical trials and in technology use, such as telemedicine and wearables, to deliver comprehensive care. Specific success factors include the development, dissemination and implementation of operational tools cocreated by multistakeholder groups with patient representation, such as ASCO–FOCR joint guidelines to expand cancer research eligibility criteria. Similarly, Centers of Excellence programs, such as GO2 Foundation for Lung Cancer's Care Continuum Centers of Excellence Networks for screening and care continuum coordination, promote the application of patient-directed treatment paradigms for comprehensive cancer care [30].

Public

The public level refers to the overall health care environment that applies to the general public. This is the level of ‘Big Data’ systems, which includes codification schemes, such as International Classification of Diseases – 10th revision codes, aggregated insurance claims data and data related to lifestyles, environments and human biology as collected in programs such as the NIH's All of Us Research platform [31].

At this level, diverse patients may engage in establishing global and national research priorities, determining public health policies, and designing public awareness and disease prevention campaigns, such as cancer screening drives. National policies and programs support the ‘development of pipeline training programs for health care professionals representing the ethno-cultural and linguistic diversity’ of the public [3].

Call to action

We can take action today to reimagine equitable cancer care. As individuals, we can educate ourselves about the legacy of racism in health care as well as about principles and practices of patient engagement. We can advocate within our organizations for the adoption of tools, toolkits and training programs that have been cocreated with patients and community stakeholders. Following are five action areas for individuals and organizations. See Supplementary Resources for examples of specific programs and recommended reading.

Five action areas & next steps for individuals & organizations

Conclusion

A moment of reckoning for racial justice is upon us. Dollars and other resources from philanthropies, government and industry are being directed en masse to health equity efforts – cancer care among them. At the same time, patient engagement practices and tools along with health care technologies have evolved to a point where we can intentionally apply them to reimagine and implement a more equitable, patient-centered, data-driven system to support cancer prevention, diagnosis and quality care serving all populations. As a society, we have the resources available right now to take action to drive systemic changes to cancer care policies, treatment practice and research infrastructure. As oncology professionals, we have the capacity right now to critically evaluate our operations for equity, to intentionally address medical, social and economic conditions and to bring patient-level precision into precision medicine for cancer. Now is the moment for each of us involved in oncology, individual and organization alike, to take the next step.