NEW YORK – Researchers at the Dana-Farber Cancer Institute and Brigham and Women’s Hospital are expanding a study to identify and address racial and ethnic barriers to genetic education and testing for pancreatic cancer patients and their families.
The study, called REGENERATE, received $300,000 in grant funding this month from the nonprofit PanCAN. The funds, provided by Janssen, will support the project through 2024, and allow researchers to expand it into its second phase, during which they will develop and implement a pancreatic cancer-specific online communication system to educate Black and Latinx patients about genetic testing and early cancer screenings.
The REGENERATE study is co-led by Sapna Syngal, the principal investigator and director of research at the Center for Cancer Genetics and Prevention at Dana-Farber, and Nicolette Juliana Rodriguez, the project lead and the codirector of fellowship initiatives at Brigham and Women’s for trainees underrepresented in medicine in the department of medicine.
The researchers conducted focus groups with Black and Latinx individuals and community leaders and evaluated their knowledge about obtaining genetic testing and other cancer screening services; their ability to use the internet to access health information; and their cancer worries and risk perceptions, and medical mistrust.
They have already begun conducting these focus groups and aim to interview about 100 participants, Syngal said. Once the focus groups are finished, Syngal’s group will analyze their findings and begin developing the online resource and outreach strategy for a potential national expansion of the program.
“The goal for the next two years is to design a larger study that will really be embedded in these communities and will facilitate greater use of genetic testing and risk assessment,” Syngal said. “We hope to do a national study where people could engage through PanCAN as their community partner to be able to get testing on a nationwide basis.”
The education and testing effort is focused on cascade testing for close relatives of pancreatic cancer patients. Syngal noted that these individuals should get tested for genetic mutations associated with higher risk of pancreatic cancer. She said there are 13 genes associated with risk that should be screened for mutations: APC, ATM, BRCA1, BRCA2, CDKN2A, EPCAM, MLH1, MSH2, MSH6, PALB2, PMS2, STK11, or TP53.
The REGENERATE study extended from a previous program, called GENERATE, that focused on cascade testing for family members of patients with pancreatic cancer. Syngal said the uptake of the at-home testing and video-based genetic counseling in that study was high, but the study had low accrual in Latinx and Black communities. In the GENERATE study, 96 percent of the 632 patients enrolled were white or Caucasian.
However, Black and Hispanic pancreatic cancer patients often have higher rates of morbidity and mortality and present with more advanced disease at diagnosis compared to white patients, according to a 2019 review published in Health Equity.
“We got a lot of geographic diversity and economic diversity, but we did not get racial and ethnic diversity, so that led to REGENERATE,” Syngal said. “We started by talking to some of the community networks and trying to increase accrual rates in these populations. Basically, the feedback we got was that we need to really understand [these communities’] specific challenges before we are able to make a dent in this.”
Over the past year, the researchers have focused on two groups to interview: individuals who have had a family member affected by pancreatic cancer and community stakeholders, such as community advocates or policymakers. From these two groups, they hoped to identify the barriers to reaching families with a history of pancreatic cancer and understand how to better engage them to learn about and get genetic testing.
From those interviews, the researchers identified access, language, and mistrust as the main difficulties. The logistics barriers kept individuals in these communities from easily accessing testing or genetic counseling; language barriers hindered their ability to learn about these services; and mistrust of the medical and research community held them back from engaging in learning or testing in the first place.
Based on these findings, the team is developing an online system to help Black and Latinx patients learn more about genetic testing and its implications for pancreatic cancer risk. The resource will have materials in several languages and ensure the information is accessible for all health literacy levels.
“The biggest thing that we’re hearing is that they need the interactions to be with people that are from their own communities to be able to have trust in the system,” Syngal said.
Because the researchers are trying to reach family members of people with pancreatic cancer, they often already understand how serious the disease is. She also said previous research has shown that once these patients know that cascade testing is an option and it is easier to access, the uptake is high. “If you’ve dealt with pancreatic cancer in your family and have had that experience, we’ve found that people actually want to know their risk and they want to be able to do everything they can to prevent it,” she said.
Over the next two years, the researchers will wrap up the focus groups and apply their findings to the design of the larger cluster randomized-controlled trial. The goal is for that study to be “embedded” in these communities to increase trust in genetic testing and facilitate better access. That study will monitor how the education efforts and increased outreach to Black and Latinx communities affect the rates of cascade testing and patient outcomes.
Once these patients undergo genetic testing, they can then be eligible for enhanced cancer screening if they have a genetic mutation that is associated with higher risk. For instance, patients with these mutations may start cancer screening earlier or get more intensive screening, for example with MRI, than those without these mutations. Many of the mutations associated with higher risk of pancreatic cancer are also associated with higher risk of other cancers, such as breast and colon cancer, Syngal noted.
“This study is going to have broad implications not only just for pancreatic cancer testing but for cancer genetic testing generally, in these underrepresented communities,” she said. “I’m very grateful to PanCAN for funding this study because this is in an area that we can have a huge impact on pancreatic cancer mortality.”