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Mapping a Path to Clinical Trials: Bringing Fox Chase’s Innovative Care to the Temple Community

Illustrations by Mark Harris
Illustrations by Mark Harris
Illustrations by Mark Harris

Bringing Fox Chase’s Innovative Care to the Temple Community

By Marian Aureimma

Originally published in Forward magazine – Winter/Spring 2023

Clinical trials are among the most important resources when it comes to effectively treating challenging cases of cancer, but at Fox Chase Cancer Center, these trials encompass much more than just testing new drug candidates that may be more effective alternative treatments. They can also provide preventative screening and help determine ways to reduce drug side effects.

In many instances, however, helping patients map a path so they can enroll in clinical trials is challenging. Whether it’s misconceptions or barriers to enrolling, there remain large populations that are lost when it comes to clinical trials, and as a result, are underserved by them.

Fox Chase and Temple Health plan to change that, starting with a recent grant from Stand Up To Cancer (SU2C), which raises funds to accelerate the pace of research to get new therapies to patients quickly and save lives. The principal investigators for the grant are Fox Chase researchers Martin J. Edelman, chair of the Department of Hematology/Oncology, and Linda Fleisher, a research professor in the Cancer Prevention and Control research program.

The funding, which is a part of the SU2C Diversity in Early Development Clinical Trials Research Grants Program, will finance a new project, “Accelerating and Diversifying Access to Clinical Trials” or ADACT, which will allow for a more efficient patient experience and also use innovative data analysis and technology to identify key populations in need of resources.

“The primary purpose of the grant is to increase enrollment of patients who have typically not had the opportunity to participate in clinical research into early-phase clinical trials, which evaluate new drugs and approaches for the treatment of cancer before these new drugs are compared with the prior standard of care,” said Edelman.

The effort will focus on expanding access to oncology clinical trials across Temple Health, especially at Temple University Hospital. In addition to supporting patients enrolling in clinical trials, community ambassadors will help educate the public by using the ambassadors’ experiences to encourage more patients to consider and participate in what can be a life-changing treatment plan.

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Sukhmani Kaur Padda, MD

The $550,000 grant will assist researchers in creating a clinical trial infrastructure that will identify and implement changes that more effectively reach patients in underrepresented communities replaced by Temple Health. The main area that Temple serves, North Philadelphia, has higher rates of poverty and higher-than-expected rates of cancer mortality than the rest of the city. Michael Young, Temple Health’s CEO, has demonstrated the system’s strong support for the program by matching the grant dollar for dollar.

Temple has been recognized for its connection to its community, with Temple University Hospital being named the most racially inclusive hospital in Pennsylvania and one of the most racially inclusive in the United States by the Lown Institute, a healthcare think tank. But much work remains.

"We’ve made much progress in expanding access to clinical trials,” said Sukhmani Kaur Padda, MD, Professor, Clinical Investigator Track, Thoracic and Phase I Oncology and Vice Chair of Medical Oncology, Fox Chase Cancer Center at Temple University Hospital. "Although the momentum for the SU2C initiative started well before I arrived in 2023, over the past year, Dr. Edelman, Dr. Fleisher, and I, alongside a multifaceted team, have worked on nine new clinical trials and enrolled 63 individuals from the communities around Temple Health—with eight patients on early-stage trials, which is critically important for discovering breakthrough therapies.”

Community Ambassadors

To address the major hurdle of reaching out to find clinical trial participants, Fox Chase’s Office of Community Outreach is working with the team and enlisting the community itself. Researchers have patient advocates who have firsthand experience with clinical trials and are relying on them to let prospective patients know what they can expect from trials and how they can help change lives.

If there’s one person who is familiar with this, it’s Lydia Henson, 58, of Philadelphia. In 2014 she was diagnosed with stage IV pancreatic cancer after struggling with fatigue and back pain. She came to Fox Chase for a second opinion and was started on an aggressive course of chemotherapy. Although the treatment was effective, she experienced challenging side effects that left her feeling sick for days at a time.

After a few years of this intense treatment, Henson agreed to genetic testing at the suggestion of her doctor, Efrat Dotan, a medical oncologist. The testing showed that she had a PALB2 gene mutation, one of the major known susceptibility genes for pancreatic cancer. Having a mutation in this gene qualified Henson for the clinical trial she remains part of today.

“When I was first diagnosed I didn’t want to get the genetic testing because it just seemed like too much at the time. But after four years of dealing with difficult chemotherapy treatments, I finally decided to do it,” said Henson. “If I had never gotten tested I would have never known about this trial. People shouldn’t be afraid of genetic testing because it helps a great deal in being able to participate in clinical trials.”

Henson has been enrolled in the trial for three years now. Instead of spending five hours at the hospital every other week for conventional chemotherapy, she is able to take six pills a day at home, with monthly in-person scans. As an added bonus, the pills have fewer side effects than chemotherapy did.

Henson said she is looking forward to speaking with people about how clinical trials like hers can change a patient’s quality of life, just as they changed hers. Fox Chase and Temple researchers are continuing to define the roles of patient advocates like Henson.

“I really want to be able to tell people my story so that they can be helped. Maybe if they could talk to me and see me, and hear a little bit of my story, it would give them the courage and the strength to go for a clinical trial if they qualify.”

- LYDIA HENSON, PATIENT ADVOCATE

 

“When I was first diagnosed, I never really thought about clinical trials. … This trial has given me the outlook that my life isn’t necessarily over. You can live with cancer and have a normal life. In fact, I go along and take my medication and sometimes I even forget I have cancer,” said Henson. “I really want to be able to tell people my story so that they can be helped. Maybe if they could talk to me and see me, and hear a little bit of my story, it would give them the courage and the strength to go for a clinical trial if they qualify.”

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An initiative to diversify the patient pool for cancer clinical trials will involve a number of researchers and clinicians from both Fox Chase and Temple Health. Clockwise from top left are Martin J. Edelman, Amy J. Goldberg, Linda Fleisher, and Shannon Lynch.

But before Henson can convince a patient to participate in a trial that meets their needs, researchers have to determine what those needs are. That’s why Shannon Lynch, assistant professor in the Cancer Prevention and Control research program, has been harnessing the power of geospatial analytics, which uses computational tools to build a visual representation of specific locations and events in order to identify communities affected by cancer. Lynch’s team uses these tools to build maps and study which neighborhoods are impacted by cancer risk and cancer health disparities.

“We want to consider that when we’re designing or evaluating our research studies we are really capturing people in our communities who are most impacted by cancer. This way we can make sure members of those communities know more about clinical trials and how to access them,” said Lynch.

“Essentially, we map what neighborhoods have higher rates of cancer mortality or incidence, as well as what factors could be helpful to explain these higher rates,” she added. They found that many of the neighborhoods that are shown to have a higher cancer burden are also affected by unfavorable social drivers of health, the environment in which people are born, work, and live.

These drivers, including economic stability, educational attainment, access to healthcare, and social context—including policies that have led to discriminatory practices that can affect a neighborhood’s built environment, such as housing—can collectively affect a person’s health.

“Reaching out to diverse racial and ethnic groups and individuals exposed to social drivers we know can impact cancer outcomes is important, not only to ensure representation in clinical trials, but to begin to address the barriers underserved populations face when diagnosed with cancer or deciding on a clinical trial,” said Lynch.

“We can use data-driven approaches to identify communities who might need to hear more about cancer and clinical trials, but it is critical to engage community partners and patients who have lived these experiences. They are experts in their communities. Only through the combined efforts of community, clinicians, and researchers can disparities begin to be addressed,” added Lynch, who is also the Assistant Director of the Office of Community Outreach at Fox Chase Cancer Center and Co-director of the Center for Biostatistics and Epidemiology at the Lewis Katz School of Medicine at Temple.

Expanding Access to Care

Fox Chase Map

Community advocates and geospatial research are just a few of the puzzle pieces of Fox Chase and Temple Health’s plan to bolster clinical trial participation. “All of the pieces have been in place. What we’re doing now is bringing them together with Temple Health,” said Edelman.

He and Fleisher are in the process of putting together a multidisciplinary team that will help provide not only more access to patient care, but more supportive services for those participating in trials. They are working with Temple Health to expand these services and provide a more seamless experience for patient care in clinical trials. To begin creating this framework, Temple and Fox Chase will be focusing on three major pillars—infrastructure, patient education, and community outreach.

“At Temple Health, we have a fairly large number of patients, but we have not had adequate resources in terms of research and physician personnel. We also need to improve the infrastructure, which would include how to get people into clinical trials, how to retain them, and obtaining the specimens to perform these studies, among other things,” said Edelman.

“In addition to building infrastructure at the Temple University Hospital campus, we are working on best practices of helping eligible patients from Temple University Hospital to take advantage of additional clinical trials that may benefit them and may be available only at Fox Chase Cancer Center - Main Campus. This includes transportation for the trial and wrap-around support. It’s important to offer patients trial treatment options, and it is also important to support patients throughout their participation in the trial,”

- SUKHMANI KAUR PADDA, MD

 

To improve infrastructure, Amy J. Goldberg, The Marjorie Joy Katz Dean at the Lewis Katz School of Medicine at Temple and surgeon-in-chief at Temple Health, has been working with Edelman on creating more physical space for these trials. Additionally, they are working toward creating an onsite biobank to further improve the efficiency of clinical trial studies. The biobanks are essential for collecting, storing, and analyzing biological samples for use in procedures that involve molecular-based assessments and pathology-related diagnoses.

“This is a great integration between Fox Chase and Temple. We’re all very excited that more of our patients at Temple will have access to cutting-edge care.”

- AMY J. GOLDBERG, THE MARJORIE JOY KATZ DEAN, LEWIS KATZ SCHOOL OF MEDICINE

 

“What I’m most excited about is that the same clinical trials that are ongoing at Fox Chase will now be open to our Temple community in North Philadelphia,” Goldberg said. “It will take all of us working together on both campuses to really be able to do this efficiently and ensure that our patients have the same access. This is a great integration between Fox Chase and Temple. We’re all very excited that more of our patients at Temple will have access to cutting-edge care.”

A Holistic Approach

Fleisher said the most important part of this massive undertaking, and what the grant provides funding for, is a more holistic approach to these issues.

“It’s not just about the infrastructure or community education or supporting patients. It’s about all of the issues being addressed at once. That’s how you move the needle forward, and I think it’s incredibly exciting,” she said. “It’s important for every patient to have this option. It’s really going to open the door for them to consider participating in a clinical trial. It’s another avenue to getting state-of-the-art treatment.”

To make this all happen, Edelman said they are creating an integrated clinic to support patients, one that includes services such as palliative care, nutritional assistance, and an overall assessment of patient needs. This multidisciplinary effort will involve many others at Fox Chase and Temple who will be critical to the success of the initiative, including colleagues from community outreach like Evelyn González and clinicians Jessica Bauman and Alvaro Pereira-Rico.

“There’s the initial consideration of choosing the trial, but we also have to consider how we can support patients and minimize their barriers to staying in a trial.”

- LINDA FLEISHER, CANCER PREVENTION AND CONTROL RESEARCH PROGRAM, FOX CHASE

 

And while infrastructure and patient education play a pivotal role, eliminating barriers to care remains a top priority as part of community outreach efforts. “We have to help patients be open to considering a trial,” said Fleisher. “There’s the initial consideration of choosing the trial, but we also have to consider how we can support patients and minimize their barriers to staying in a trial. We will be building in transportation services so that patients in North Philadelphia who want to participate in a trial happening at Fox Chase can do that.”

Novel Patient Tools

Before a patient even begins to seek cancer care through a trial, they will likely have many questions regarding how to proceed, which can often be a major source of anxiety and a roadblock for enrollment.

Fleisher, whose lab focuses on research and quality improvement initiatives, conducted a two-year study with her colleagues to explore some of these patient dilemmas. Through in-depth interviews with, and surveys of, African American cancer patients, Fleisher and Temple colleague Sarah Bauerle Bass were able to gain a more holistic understanding of the common concerns of underrepresented cancer patients regarding clinical trials.

They found that many of those who did not participate felt that they were not given enough information about the availability of clinical trials or what the process entailed. Those findings helped the researchers develop an app called mychoice to provide a resource for cancer patients to help them address concerns and improve their discussions about clinical trials with their providers.

With this new tool, potential trial participants can watch video interviews with cancer patients who have made decisions about involvement in clinical trials. In addition, patients can select from a wide range of questions that Fleisher hopes they will use in discussions with their healthcare providers. Interview results showed patients felt more positive about the possibility of participating in clinical trials after receiving information through the app.

“The hope is that mychoice will empower patients to be proactive in their treatment protocols and feel comfortable discussing their concerns with healthcare providers,” said Fleisher. “Until patients understand and feel comfortable with their healthcare options, none of the other facets of care can work.”