Bringing Clinical Trials in Cancer Closer to Home

When Sue Schroder, 72, received a diagnosis of follicular lymphoma in late 2009, she pushed through the numbing shock she felt and then faced her diagnosis head-on. Rolling up her sleeves, she dived into the research, exploring her options and bouncing ideas off family members. After getting a second opinion, she decided to enter a clinical trial.

Her decision was made easier because the trial was available in her hometown of Grand Rapids, Michigan.

“I received treatment through the Cancer and Hematology Centers of Western Michigan at both the Spectrum Health Lemmen-Holton Cancer Pavilion and at the Mercy Health Saint Mary's Lacks Cancer Center,” says Schroder. “These are the same places I would have gone if I hadn't been part of a trial. They were 10 minutes from my home, which made a big difference, especially after I became more debilitated from the treatment. I also had my close friends available to go with me to my appointments and to offer moral support and relaxation when I needed to get away from everything that I was living through."

The clinical trial consisted of chemotherapy along with a monoclonal antibody treatment called Rituxan (rituximab) given during each session. This regimen was followed by one shot of radioactive material plus four years of maintenance therapy with Rituxan alone — two years longer than standard of care at that time.

By all accounts, the trial was a success. Ninety-four percent of trial participants were without disease progression at the two-year mark. The only downside of the trial was that four years on Rituxan proved to be too long for many patients due to the cumulative toxicities, she found out from her research nurse.

At 10 years, Schroder shows no evidence of disease. She attributes her favorable outcome to her local hospital’s affiliation with the Cancer Research Consortium of West Michigan (CRCWM), which is made up of 11 hospitals currently running about 140 new trials and monitoring an additional 250 ongoing trials. The consortium, part of the National Cancer Institute’s Community Oncology Research Program (NCORP), makes it possible for Schroder and other patients like her to participate in national clinical trials and receive the same potentially lifesaving care as patients living closer to the National Cancer Institute (NCI) and academic medical centers.

NCORP is just one way that national cancer clinical trials can be brought to smaller communities. Health systems and cancer centers have developed other models too. Some large health systems, such as Jefferson Health in Philadelphia, have expanded their reach to outlying communities, offering state-of-the-art trials at several different centers. The University of Texas MD Anderson Cancer Center in Houston has expanded on this concept by providing its clinical trial protocols to institutions nationwide within its Cancer Network. Each approach has been structured differently, but all of them have a common goal: Offer clinical trials to patients in the hope of providing the highest-quality care in the most convenient setting possible.

NCORP Casts a Wide Net

For many hospitals and cancer centers, the opportunity to participate in studies developed by NCI is a big draw. NCORP is a large program and is currently funding 46 sites, 14 of which are in minority and underserved communities. It also offers a range of trials, from examining new treatment options and screening techniques to preventive strategies and ways to improve the cancer delivery system.

“Clinical trials are complex to run, and we are able to take some of the burden off the sites,” explains Dr. Worta McCaskill-Stevens, a medical oncologist and director of NCORP. “We provide the infrastructure for the trial and cover the cost of the intervention, which allows the medical team to focus on their patients.”

CRCWM is a good case in point. “We would not be able to fulfill our regulatory and financial obligations without NCI support,” says Connie Szczepanek, director of CRCWM. “But the relationship is definitely a two-way street. NCI relies on community involvement to collect much-needed data. More than 35% of enrollment in NCI studies takes place in community sites.”

Dr. Richard Deming, principal investigator for Catholic Health Initiatives’ NCORP grant, agrees. Deming oversees a large NCORP grant that has 53 sites nationwide and is also medical director of the Des Moines, Iowa, site, MercyOne Cancer Center. Deming adds that since 85% of patients with cancer are treated at community hospitals, bringing trials to the community makes sense for everyone.

“Allowing community cancer programs to enroll patients has shown that in addition to benefiting patients, it also allows the trials to scale-up quickly, accelerating the speed at which results become available,” Deming says.

Although a common perception is that clinical trials mostly study new treatments, they actually cover many different aspects of cancer care. “We’re currently involved in a screening study, where we’re comparing two- dimensional to three-dimensional mammography,” says Deming. “This is one of the few clinical trials in 25 years that focused on screening technologies to determine which is most effective for patients.”

Other types of trials include an examination of financial toxicity, a growing problem among patients with cancer. Deming and his colleagues across many sites are evaluating how cost affects patients’ quality of life and how concern about finances affects adherence to treatment. Other trials include investigating compliance with oral treatments, which patients take at home, and how to better manage side effects of treatment, such as neuropathy (nerve damage in the hands and feet that result in weakness, numbness and a tingling feeling).

Valeria Mason, 61, of Alleman, Iowa, is currently participating in a neuropathy trial that is occurring simultaneously with her chemotherapy and targeted therapy for HER2-positive breast cancer. The drugs in her treatment regimen are known for causing in this approach has led large cancer centers to develop innovative models specifically designed to meet the needs of their diverse patient populations.

Bringing Clinical Trials to Patients

Large cancer centers are known for their exemplary treatment, but most are located in large cities. The traditional model for clinical trials has been for patients to travel to those centers, but it has becoming increasingly clear that this approach is no longer working for patients.

“We’ve noticed that over the past few years, patients are actively looking for clinical trials, especially those who have exhausted standard treatments. We had already been growing our network of collaborators, which include 20 institutions in 16 states, by sharing expertise and resources. It was a natural next step to bring them into our clinical trials program,” says Dr. Michael Kupferman, senior vice president of clinical and academic network development at MD Anderson Cancer Center in Houston. "We now have 13 cancer network sites with 65 ongoing protocols, for which nearly 1,700 patients have been recruited."

But clinical trials are complex, so getting a new site up to speed is no easy task. Support in operational capabilities and regulatory and safety oversight, as well as access to data, are just a few issues that must be addressed. Most of the trials, which are usually large phase 2 or 3 trials, were designed by MD Anderson investigators and focus on the most common cancers, including breast, lung, genitourinary and gastrointestinal cancers. Some trials are open that target rare tumors and certain mutations as well. Studies range from investigating new types of radiation for breast cancer to testing new targeted therapies to prevention trials focused on tobacco cessation.

“We have been on a remarkable journey with our collaborators,” says Kupferman. “In addition to easing the burden for patients, we’ve been able to work closely with local physicians, educating them on the latest in cancer care. We were among the first to grow clinical trials to scale, and we plan to continue to do so.”

The Seattle Cancer Care Alliance (SCCA) has a similar model in place, with SCCA's main campus serving as the hub of its five satellites in the surrounding community and its five-state network. The clinical trials in the community are managed by experts from SCCA, who help with start-up, recruitment and overall management. One of the values of this model is that underserved communities have an opportunity to participate in clinical trials.

“The desire to work in these communities has been a huge force in our push to expand our networks,” says Dr. Jennie Crews, medical director of community sites and research integration for the SCCA Affiliate Network. “For example, one ongoing trial is conducting genetic testing for men with metastatic prostate cancer. After patients take a saliva swab and send it to designated labs, investigators can determine the frequency of certain genetic markers in this population. This has proven to be a successful study (that was) relatively easy to conduct in the community.”

Another health system, the Sidney Kimmel Cancer Center in Philadelphia, part of Jefferson Health, has gone beyond providing the community access to its clinical trials; it also uses population science to tailor the trials to the needs of its network, which include four Sidney Kimmel Cancer Center Advanced Care Hubs in downtown Philadelphia; Abington, a nearby suburb; Torresdale, in northeast Philadelphia; and Washington Township in New Jersey.

“For example, northeast Philadelphia has a high smoking population, so to better serve that community, lung cancer screening and trials are a priority,” explains Karen Knudsen, executive vice present of oncology services at Jefferson Health and enterprise director for its Sidney Kimmel Cancer Center. “In Abington, there is a high level of cervical and ovarian cancer, making this community an excellent candidate for our women’s cancer trials."

Knudsen is passionate about her belief that providing access to clinical trials in the community is essential. "They are our best chance to improve outcomes and eliminate disparities," she said.

Although the COVID-19 pandemic has made getting medical care difficult, it has also prompted a few improvements to clinical trials. “We’ve relaxed the consent process, allowing patients to complete the paperwork online,” says Crews. “We’ve also allowed patients to use local labs to avoid unnecessary travel. Not only have these innovations been safer for patients, they also have expedited these important parts of the clinical trial process.” McCaskill-Stevens concurs, adding that telehealth, which gives patients easy access to their physicians, will likely play a greater role in clinical trials in the future.

By all accounts, the future of clinical trials appears to lie in the community. Other institutions adopting a network model include Dana-Farber/Harvard Cancer Center in Boston, City of Hope in Los Angeles and Moffitt Cancer Center in Tampa, Florida. This growing movement means that more patients than ever will have access to state-of- the-art care.

“For both patients and providers, there is great joy in being part of the pursuit of knowledge,” says Deming. “Clinical trials enhance and elevate the overall quality of care and show the communities involved that their health system is committed to excellence.”