Personalized Initiatives Empower Patients to Actively Participate in Cancer Research

Cancer care institutions have responded to an interest from patients to be more involved in the research process than in years past by developing several patient-partnered research initiatives. However, investigators who champion patient-partnered research have experienced challenges to effective implementation of some of these ideas, such as the complicated patient consent process, the free sharing of health information, and interoperability issues between various electronic health record (EHR) systems.¹

“Traditionally, we’ve done research in a passive framework, where patients sign consent, they participate, and then they go back to their lives, and there’s not always a direct engagement with them along the process from study conception to protocol development to understanding the results and returning those results back to them,” Vinayak Venkataraman, MD, said in an interview with OncologyLive. “In recent years, we’ve come to understand that patients want to have a more direct role in research, not just participating but also being partners in that research and better understanding how that research is being developed and how it’s being used after the completion of the study.”

Venkataraman is the sarcoma pathways director for the Center for Sarcoma and Bone Oncology Sarcoma Center at Dana-Farber Cancer Institute and an instructor in medicine at Harvard Medical School, both in Boston, Massachusetts. One such patient-partnered research initiative is the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network. First announced in 2019 as part of the Cancer Moonshot Initiative, the PE-CGS Network is made up of 5 National Cancer Institute–funded research centers.^2,3

The Ohio State University serves as the coordinating center of the PE-CGS Network. The PE-CGS Network member institutions collaborate to develop best practices and address common issues, with the goal of better engaging with patients and community members to develop networks of direct participant engagement in research. The PE-CGS Network placed a particular emphasis on filling research gaps in the study of rare, deadly cancers.²

"All of the sites are focused on promoting effective participant engagement and research, and by doing so, accelerating discoveries, especially in rare and understudied cancers or in understudied or underserved populations,” Venkataraman explained. “Each center has different research initiatives, but they’re united to determine how to better promote direct-to-participant engagement. This includes leveraging technology, [such as] visual and digital platforms. [We also want to] more culturally appropriately communicate our consent processes, protocols, and results.”

PE-CGS Network stakeholders (n = 138)—consisting of scientists, clinicians, genetic counselors, and research funders (93%) as well as community and patient representatives (7%)—met in 2021 to identify priorities for participant engagement within the PE-CGS Network. They set the top priorities for participant engagement in cancer research as tailoring education and communication materials to participants, identifying measures of participant engagement, identifying optimal strategies for participant engagement, understanding cancer disparities in the context of genomics research, and personalizing the return of genomic data to participants.³

To tailor materials to participants, the stakeholders recommended using culturally sensitive language, writing at recommended reading levels, translating materials into multiple languages, using images and figures, and using educational materials to support informed consent. For example, the PE-CGS Network member institution Optimizing Engagement in the Discovery of Molecular Evolution of Low-Grade Glioma is employing a novel digital platform, Hugo Health, to enable bidirectional patient-centric messaging and education. In terms of measuring patient engagement, PE-CGS Network stakeholders suggested that data on participant satisfaction, changes in knowledge, study enrollment and retention rates, changes in trust with researchers, and genomic and clinical discoveries be collected to determine the effects of participant engagement in cancer genomics research. PE-CGS Network member institution Count Me In PE-CGS Center is using an iterative feedback loop to collect community input on study design, including a patient intake survey.

With regard to identifying optimal engagement strategies, the stakeholders discussed rapid-cycle research and the use of comparative effectiveness as methods to address suboptimal research strategies and to evaluate culturally tailored engagement efforts. The PE-CGS Network member institution Washington University PE-CGS is engaging individuals who decided not to participate in research efforts to better understand reasons for refusal and to modify practices accordingly For the fourth priority on understanding the role of care disparities in cancer genomics research, stakeholders recommended the collection of data on such factors as patient environment, socioeconomic status, and structural racism and the integration of these data with cancer genomics data.

Regarding the fifth and final priority, personalizing the return of genomic findings, the stakeholders recommended collecting participants’ input on how to best deliver and aid in the understanding of genomic results, including who participants would prefer explain the results and providing additional informational materials to participants and their families. These strategies are being employed by the PE-CGS Network member institution Center for Optimization of Participant Engagement for Cancer Characterization.

“At the end of the day, patients own their data,” Venkataraman said. “They want to contribute to research, but they’re being hindered in doing that, and a lot of researchers are hindered in being able to do that because of financial, legal, and technical barriers.”

Addressing the Persistent Roadblocks to Patient-Partnered Research

Despite the frameworks for patient-partnered research established by the PE-CGS Network, effectively applying these concepts has met with some difficulties, so additional efforts are needed, according to Venkataraman. In an article published in the Journal of Clinical Oncology, Venkataraman and his coauthors cited the participant consent process as a hindrance to patient-partnered research that needs to be improved. They noted that the process remains time-consuming despite the PE-CGS Network’s efforts, often taking more than 30 minutes to complete and requiring potential participants to parse through clinical trial documents with a median word count exceeding 5000 words.¹

The investigators pointed to the National Institutes of Health All of US informed consent process, which uses animations and interactive quizzes to assess participants’ understanding of a study at enrollment, as a model to consider further utilizing. Research has shown that 95% of all enrollees who used the All of US consent process could accurately answer questions about the study process.⁴

“The consent process itself has a lot of barriers,” Venkataraman said. “Many consent forms have a lot of verbose and legal jargon that is difficult for a lot of patients, or even providers, to understand. They’re [still often] not given in languages outside of English, which is unfortunate when you’re trying to engage a diverse population. They’re not tailored to different developmental ages; an area of interest of the PE-CGS Network is encouraging young adults and adolescents to participate in research.”

Despite patient consent allowing investigators to access and review health data, quickly obtaining these records has presented another challenge to patient-partnered research. Although patients can quickly obtain their own health information, institutions are often unable to obtain it due to ownership of the EHR housing the information. Thus, investigators who are trying to practice patient-partnered cancer genomic research must often navigate these varying institutional rules, which can be time-consuming and costly.¹

“Even though [patients] have a legal right to access to their health information, it’s often very challenging for them to share that information with relevant providers and researchers,” Venkataraman explained. “The actual process of getting that data from institution A to institution B can be very cumbersome and costly for the research teams. We need to create infrastructures and technologies that allow patients to directly access their data and share it with whomever they want on a platform that’s readable and interoperable.”

Venkataraman added that the lack of interoperability between EHR systems also contributes to the inability to transfer patient data from one institution to another and requires investigators interested in patient-partnered research to navigate various coding, specifications, capabilities, and data transfer capabilities to access patient EHR data. However, ongoing initiatives from the Office of National Coordinator for Health Information Technology, such as the Trusted Exchange Framework and Common Agreement and the United States Core Data for Interoperability, are aiming to address this issue.

“We’re in an era where patient engagement and empowerment are important to making advances in [the treatment of patients with] rare and aggressive diseases,” Venkataraman said. “Patients are motivated to advance research through their direct participation, and it’s important for them to have a relationship with and respect from the research team [as well as] transparency and fidelity of data transfer. Anything we can do from an individual, health system, and research level to empower patients to directly participate in research and to have a bidirectional relationship with research [is important]. Using both technology and more culturally appropriate research methods, we can make a lot of advances in the future.”

References

1. Venkataraman V, Martin-Giacalone BA, Drake BF, et al. Overcoming systemic barriers to make patient-partnered research a reality. J Clin Oncol. Published online August 2, 2024. doi:10.1200/JCO.24.00347
2. About us. PE-CGS. Accessed October 8, 2024. bit.ly/3Y1WtUK
3. Schuster AL, Crossnohere NL, Bachini M, et al; Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network. Priorities to promote participant engagement in the Participant Engagement and Cancer Genome Sequencing (PE-CGS) Network. Cancer Epidemiol Biomarkers Prev. 2023;32(4):487-495. doi:10.1158/1055-9965.EPI-22-0356
4. Doerr M, Moore S, Barone V, et al. Assessment of the All of Us research program's informed consent process. AJOB Empir Bioeth. 2021;12(2):72-83. doi:10.1080/23294515.2020.1847214