Patient Advocates: Expanding Their Role in Conducting Successful Clinical Trials

The first patient advocacy organization led by cancer survivors was born 20 years ago when 23 leaders in the cancer community met in Albuquerque, New Mexico, and established the National Coalition for Cancer Survivorship (NCCS). The early efforts of the NCCS and other advocacy organizations that grew up around it were directed at legislative and policy issues for cancer survivors. The importance of the patient perspective was recognized on a national scale when the NCCS became one of the first two consumer representatives to be invited to join the National Cancer Policy Board (now renamed the National Cancer Policy Forum).

As the NCCS commemorates its 20th anniversary, the patient advocacy community at large celebrates accomplishments within an expanding arena. During the last two decades, patient advocates have earned respect for their work in lobbying for legislation that ensures high-quality cancer care, for raising millions of dollars for cancer research, and for heightening awareness of clinical trials. Advocates now have a “seat at the table” for discussions and decision-making on cancer-related issues in a range of settings, from the National Cancer Institute (NCI) to community-based oncology practices.

Not all patient advocates are alike. Some lead national advocacy organizations and others simply lend an ear when someone, often a stranger, is newly diagnosed with cancer. But whether working within the halls of Congress or the waiting rooms of cancer centers, advocates try to foster a better understanding of clinical trials and the opportunity they offer for best available care.

“There are so many different ways that patient advocates can make a difference,” says Melinda Mangialardi, a patient advocate affiliated with the North Central Cancer Treatment Group (NCCTG; Rochester, Minnesota). Mangialardi is a 6-year breast cancer survivor who felt “fortunate” that the cancer was caught at an early stage, and wanted to “make a difference.” Since her diagnosis, she has been active in raising awareness about the importance of clinical trials. “I didn't have a chance to participate in a trial,” she says, “but I certainly benefited by people who came before me and did participate.”

As a volunteer for the American Cancer Society, Mangialardi was instrumental in getting legislation passed in her home state of Illinois that prohibits health insurance companies from dropping a covered individual because he or she enrolled in a clinical trial. As a NCCTG advocate, she works through the Carle Cancer Center to raise awareness of clinical trials, and she is developing a newsletter designed to educate patients and others in the community. “We need to reach out and try to dispel some myths. People need to understand what a clinical trial is and why it's important. The initial diagnosis of cancer can be overwhelming. If they don't know anything about clinical trials they may be reluctant to do anything but the standard course of treatment. Therefore, it's important to educate people in the community about clinical trials before a diagnosis of cancer.”

Mangialardi works at Carle Cancer Center with another advocate, Carolyn Galey, a 2-year breast cancer survivor who is currently participating in her third clinical trial. Galey passes her card out readily to anyone who just needs to talk. “When a patient has questions, they want to reach out to someone who has experienced what they're experiencing. They need support getting through that overwhelming feeling that they're going to die,” she says. “We understand what they're going through and can identify with them.” She acknowledges that patients need to talk to their physicians about treatment options and support, but she adds, “Doctors can't reach out like we can. We're like fingerlings; we see people everywhere—in waiting rooms, in grocery stores, in church. We can help these people.”

Galey and Mangialardi are the first two advocates to work with the research team at Carle Cancer Center, and the center plans to add to its roster of advocates over time. Carle sees patient advocates as integral to enhancing awareness and support for clinical trials, which in turn will help increase accrual to trials in which the center participates. Currently, the two advocates are working to raise money for an endowment fund that will be used to assist patients who need transportation or child care. Galey and Mangialardi are also working with the research team to coordinate seminars and other outreach projects to educate patients and the community about clinical trials.¹

Education has become essential for patient advocates as well, as more knowledge is needed to keep pace with their expanding roles. Galey and Mangialardi attended a 2-day symposium hosted by the NCCTG, where cancer researchers described the design of clinical trials, explained the science of cancer, and discussed advances in treatment options. “The symposium was great for gaining a beginning understanding of clinical trials and for learning about some of the nuances of trials,” says Mangialardi. Galey adds, “With about 60 advocates there, we also had the opportunity to pull from each other's knowledge.”

Many cancer-related organizations offer educational programs to better equip advocates for their work. Among the programs are Project LEAD (Leadership, Education and Advocacy Development), a 4-day symposium offered by the National Breast Cancer Coalition; the American Association for Cancer Research (AACR) Scientist-Survivor program; and the NCI Consumer Advocacy Research and Related Activities (CARRA) program. Advocates can also take advantage of the ASCO mentor program at the ASCO Annual Meeting. This program pairs advocates with ASCO members who are available to answer questions and discuss the most important findings presented at the Meeting.

Such education is better preparing advocates to participate in research-related activities, such as service on institutional review boards, research review panels, and committees within the NCI Cooperative Groups and associations such as ASCO. Advocates serve as patient representatives on ASCO Expert Panels for guideline development, as well as on the ASCO Cancer Research Committee. Ellen Stovall, CEO of the NCCS, recently completed a term on this Committee, and Kathy Guisti, the founder of the Multiple Myeloma Research Foundation (MMRF) has begun a term. “Improving how clinical cancer research is conducted is of utmost importance to me,” says Guisti, who received the 2006 ASCO Partners in Progress Award. “To increase patient enrollment in trials, it will be critical to further engage clinicians in the community as investigators in these trials and to ensure that patients are aware of and have access to clinical trial options. I look forward to accomplishing these objectives through my participation on the ASCO Cancer Research Committee.”

Guisti's organization focuses on accelerating drug development and has raised more than $60 million for research since its establishment in 1998. Its commitment to research is also evident in the Foundation's efforts to raise awareness about clinical trials. The MMRF online searchable database contains easy-to-understand information on more than 130 clinical trials. The database is accessed by approximately 2,000 to 3,000 visitors per month, and the high number of visitors to the site is thought to have played a role in the rapid accrual to recent pivotal trials involving bortezomib and lenalidomide.

Another way advocates help to enhance accrual to trials is by providing the patient perspective to researchers designing clinical trials. To that end, ASCO and AACR invite patient advocates to participate as faculty in their joint workshop, Methods in Clinical Cancer Research. In 2006, Mary J. Scroggins, MA, joined the faculty at the popular annual workshop for fellows and junior faculty. A 10-year ovarian cancer survivor, Scroggins is president and cofounder of In My Sister's Care, an organization dedicated to eliminating health disparities and improving gynecologic cancer awareness and care for medically underserved women. She has been extensively involved with research-related activities, serving as a grant application reviewer for the US Health Resources and Services Administration and participating in the Department of Defense Ovarian Cancer Research Program (OCRP) since its inception.

Scroggins appreciated the opportunity to work with beginning clinical researchers at the Vail workshop. “It's important for advocates to interact with researchers early in their careers so that they understand what we offer to the protocol development and research process,” she says. At the workshop, Scroggins participated in lectures on clinical trial ethics, special populations, and informed consent. In one panel discussion, she was involved in role playing to illustrate what a patient should ask about a clinical trial and what information the physician should provide. “When giving informed consent, patients should know exactly what they're agreeing to do, receive, and risk.”

Another of Scroggins' assignments at the workshop was to participate in one of the protocol development groups. In this capacity, she and other faculty worked with a small group of attendees throughout the week as they refined their study protocols. “If advocates are involved when the protocol is being developed, we can help make the trial patient-friendly by raising issues the researcher may not think of,” notes Scroggins. Among the many factors she considers when reviewing research proposals are the number and kinds of medical procedures required, the convenience of treatment, barriers to representative patient participation, the side effects of treatment, and issues regarding payment for care. She also reviews the schema to make sure that it will be understandable to patients. “Educational materials related to the protocol should be developed to help patients understand the trial,” she says.

Commenting on her experience at the workshop, Scroggins says, “It was a tremendous opportunity, and I loved every minute of it. We [the advocates] were engaged in every aspect of the week, with all faculty working as equals.” It was the type of relationship Scroggins believes in. “I really believe that partnerships should be built between advocates and research institutions. We are natural partners.”

As partners with researchers and allies with patients, advocates have the opportunity to build a bridge of understanding. Their involvement in community-based oncology practices can assist physicians in reaching out to patients and the public and help patients make better informed choices about care and participation in clinical trials.

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