A Multipronged Approach Can Address Disparities in Cancer Care for Patients in Rural Communities

Ramya Thota, MD

Investigators are examining and implementing several innovations that they hope will combat the persistent issue of limited access to cancer care for patients living in rural areas, including programs aimed at increasing clinical trial enrollment for these patients and improving patient catchment area data sharing among institutions.

“[Patients] in rural areas [lack] access to highly specialized or subspecialist oncologists, and they don’t have access to ancillary resources, [such as] survivorship opportunities, supportive care, or fertility and genetic counseling,” Ramya Thota, MD, medical oncologist in the Department of Hematology/ Oncology at Intermountain Health in Murray, Utah, said in an interview with OncologyLive. “Patients in rural communities sometimes lack the necessary infrastructure [for adequate care], and trying to incorporate a clinical trial into that is a huge burden. [Patients in] a clinical trial often need to come in for regular visits, and the travel and childcare costs all add up [for patients in rural areas].”

During the 2024 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois, Thota gave a presentation that examined the current state of access to cancer clinical trials for patients living in rural communities. In her presentation, she noted that approximately 70% of US counties have no active clinical trials and identified trial access and awareness, study infrastructure, socioeconomic factors, technology, and trust/perception as the major barriers to clinical trial access for patients in rural areas.¹

To combat these barriers to clinical trial access for these patients, Thota and others have argued for the increased implementation of decentralized clinical trials. Decentralized studies use online consent forms, the home delivery of investigational products, and mobile technology such as wearables for patient monitoring to lower the barrier to entry for patients in rural communities. These studies also allow for local laboratory work and imaging as well as standard-of-care (SOC) infusions at local centers to ease the need for visits to a larger center.

“There is strong enthusiasm [about decentralized clinical trials] given how successful we have been in providing regular cancer care via telehealth. We want to bring that to clinical trials,” Thota said. “The goal and emphasis are on bringing clinical trials closer to patients’ homes, whether it’s trying to deliver drugs directly to their home or to their local health care provider in the community.”

During the COVID-19 pandemic, the use of the decentralized clinical trial approach increased nationwide to accommodate restrictions placed on in-person care to curb the spread of the virus. The FDA and National Cancer Institute (NCI) adapted their procedures to include remote electronic patient consent, electronic patient monitoring, telehealth visits, direct-to-patient drug shipments, and laboratory testing and SOC therapy administration outside a patient’s enrolling center to continue clinical trials with limited in-person contact.²

Findings from a special article from the Rural Health Working Group of the Alliance Clinical Trials Network published in the Journal of Clinical Oncology demonstrated that during the COVID-19 pandemic years of 2020 through 2022, the percentage of patients from rural communities enrolled in clinical studies increased. The increase was especially striking at NCI Community Oncology Research Program sites, which surpassed the trial enrollment seen at leading academic participating sites in each of the years from 2020 to 2022, after trailing behind the academic sites in 2019.

Moreover, a survey of the Rural Health Sub-Committee (RHSC) of the Alliance Clinical Trials Network Community Oncology Committee was conducted in 2021 to delineate member perceptions of how COVID-19–related regulatory changes influenced clinical trial enrollment in their centers and clinics. The results revealed that RHSC members who responded (n = 33) reported an increase in patients from rural areas enrolled in trials from pre–COVID-19 levels at a rate of 73%. Additionally, respondents identified remote consent (44%) and visit requirement adaptations (37%) as the process changes that had the greatest effect on enrollment. However, they also cited a lack of broadband connectivity from patients, challenges with staff in conducting remote visits, and reimbursement rates for remote engagements as barriers to implementation.

“We have come a long way in the past 4 years, but having proper broadband remains a challenge,” Thota said. “We are moving into a digital world, but how many of these patients [from rural areas] understand how to [properly] use those electronic devices that are being implemented? Some patients with poor digital literacy struggle with that.”

To continue the gains observed with the regulatory updates that were made during the COVID-19 era, the RHSC offered clinical trial design considerations designed to ease the burden on patients from rural areas. These suggestions included classifying the rurality of participants, minimizing repeat imaging within a trial, allowing remote consent for all participants, using telehealth and mobile technology, offering financial support, and emphasizing local care delivery and recruitment strategies.

Refining Catchment Area Data Sharing to Improve Care for Patients in Rural Areas

Another factor that could be limiting access to cancer care for patients who reside in rural areas is the self-determination of catchment areas of NCI-designated cancer centers. Many cancer centers have launched efforts using geospatial data to better understand disparities in care, including those faced by rural populations, and inform cancer prevention efforts. These approaches have been shown to expedite the tracking of cancer incidence and mortality trends related to catchment area geography, identify areas with cancer care disparities, and inform the implementation of interventions to address these issues.³

However, centers often engage in these efforts independent of one another, limiting the effect of an effective intervention to 1 area. In response, investigators at multiple institutions partnered to form the Catchment Area Research and Data Science (CARDS) group in 2022. The aim of the CARDS group is to foster collaboration for investigators involved in cancer center catchment area data collection, analysis, and use to streamline efforts to provide care to underserved populations, such as those in rural areas.

Todd Burus, MAS, of University of Kentucky Markey Cancer Center

“Over the past several years, cancer centers have been trying to [determine] how to best go about performing surveillance of the cancer burden in our catchment areas and multiple standards [were developed],” Todd Burus, MAS, said in a separate interview with OncologyLive. “We noticed that many institutions were doing the same things [and] accessing the same data sources. They were trying to build the same type of resources, and there were a lot of duplication efforts. The collective asked, ‘What if we were all [able to] think together about some best practices, try to develop some efficiency measures, and try to share resources in a way that we weren’t utilizing as much time and effort on the back end of trying to obtain, understand, and display these data?’”

Burus is one of the founders of the CARDS group and a data visualization specialist at the University of Kentucky (KU) Markey Cancer Center in Lexington. He was also the lead author of a commentary published in JCO Clinical Cancer Informatics, which examined the effect of 2 initiatives developed by the CARDS group that were implemented to improve access to catchment area data for researchers and ultimately improve care for underserved populations, such as patients in rural areas.

In 2018, the KU Cancer Center created the Organize and Prioritize Trends to Inform KU Cancer Center (OPTIK) program, which consists of a database and multiple data visualization applications. Data from public websites, state health department partners, and internal sources are compiled annually and used in the visualization applications, allowing researchers to examine demographic, screening, risk factor, cancer incidence, and cancer mortality trends within their catchment area. Investigators present their findings from OPTIK annually to the institution’s catchment area leadership to inform outreach efforts and identify catchment area needs.

Building upon the OPTIK concept, researchers at the KU Markey Cancer Center developed the Cancer InFocus data gathering and visualization platform, which automates the collection of catchment area data. A series of Python programs are used to access publicly available data, including cancer rates, social determinants of health, and behavioral risk factors. These data can then be evaluated alone or visualized via mapping applications.

“We’ve accessed files to create points on a map [to] see who our gastroenterologists and our colon and rectal surgeons are [and where they are located],” Burus explained. “We map them, [and one] can look at a catchment area, add that layer, and see how they are distributed. [We can look and see that] here are rural areas, here are areas where maybe we don’t have as high colorectal cancer [CRC] screening rates or where we have higher rates of CRC. This allows [investigators] to generate hypotheses so that they can begin targeting areas that they might want to reach out to [that are] the areas of greatest need.”

Burus and his coinvestigators generalized the Cancer InFocus software for use on data from any set of US counties and offered it for use by other centers through a no-cost licensing agreement. The Cancer InFocus software was subsequently licensed by KU Cancer Center to enhance the OPTIK platform and aid in the collec- tion and visualization of catchment area data. As of May 2024, the Cancer InFocus software has been licensed by 26 cancer centers and 1 state cancer registry.

References

1. Thota R. Extending clinical trial access in rural settings. Presented at: 2024 American Society of Clinical Oncology Annual Meeting; May 31-June 4, 2024; Chicago, IL.
2. Stout NL, Nikcevich D, Henderson TO, et al; Alliance Rural Health Sub-Committee of the Community Oncology Committee Members. Improving rural clinical trial enrollment: recommendations from the Rural Health Working Group of the Alliance Clinical Trials Network. J Clin Oncol. 2024;42(14):1722-1725. doi:10.1200/JCO.23.01667
3. Burus T, Martinez J, DelNero P, et al. Interinstitutional approach to advancing geospatial technologies for US cancer centers. JCO Clin Cancer Inform. 2024;8:e2400099. doi:10.1200/CCI.24.00099