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Enhancing participation in clinical trials relies on patients and physicians who are fully informed about available trials. Keeping oncologists and referring physicians apprised of open trials is more difficult in the community setting because of the lack of the supporting infrastructure of an academic institution. A particular challenge for many community practices is communicating information efficiently across multiple locations in a large geographic area. Yet such communication is vital to keep physicians and their patients active in the clinical research process.
The recipients of the 2006 ASCO Clinical Trial Participation Award (CTPA) have learned that integrating technology tools into their communication processes can facilitate involvement in trials by providing the most up-to-date information to oncologists, physicians in other specialties, patients, and the public at large.
Most of the CTPA recipients have created Web sites to increase awareness of clinical trial research in the community. On its Web site, St Joseph Mercy Hospital Cancer Program (Ann Arbor, Michigan) lists active studies with eligibility criteria, as well as consent forms and Health Insurance Portability and Accountability Act documents (Figure 1). “We can ask patients to visit the Web site and print a copy of the consent form for educational and informational purposes,” says Beth LaVasseur, the oncology research manager for the program.
The Carle Cancer Center (Urbana, Illinois) also created a Web site to keep patients informed about available trials (Figure 2). Trials are listed by disease site, and links from each trial take site visitors to the National Cancer Institute (Bethesda, Maryland) Web site to learn more about the trial. “We hope to add more features to the Web site to continue to make it user-friendly and informative to the public,” says Kendrith Rowland, MD, of the practice. As with most of the Web sites developed by the award recipients, the Carle Cancer Center site has staff-only content that is updated monthly after each institutional review board meeting. “Having up-to-date information immediately available on the Web for our home, satellite, and affiliate offices has been very helpful,” says Rowland.
The method that most of the CTPA-winning practices have used to keep physicians informed about trials is a convenient pocket-size listing of trials. This resource has made it easy for physicians to have the most current, accurate information on hand when considering a patient for enrollment onto a trial. Developing such a printed resource is time-consuming. Jane Harris, research manager of St Luke's Mountain States Tumor Institute (Boise, Idaho), who coordinates the creation of the protocol book, notes that the development, review, and distribution of the book is a team effort that requires about 19 hours spent putting together each book.
Marge Good, RN, BSN, MPH, OCN, manager of the Wichita Community Clinical Oncology Program (Wichita, Kansas) agrees that developing a protocol book is time-consuming. “We keep it simple with a pocket card of only priority trials,” she says. The priority card is color coded by month, and drugs involved in the treatment protocol are underlined. “This is especially helpful to know, because if we have a patient with no insurance, it would be nice to offer him or her a study for which the drug is provided,” she says. “It also helps the physicians make business decisions.”
As technology becomes more commonplace, these print resources are being replaced with or supported by electronic ones. Electronic listings of protocols are more efficient, especially for keeping physicians in a multisite practice informed. “We have tried to encourage physician engagement by making research as user-friendly as possible,” says Lawrence Garbo, MD, of New York Oncology Hematology (Albany, New York), which has 15 locations throughout the state. The practice publishes an active protocol list, arranged by disease site and stage, which is distributed weekly by e-mail. Each protocol has a brief synopsis of eligibility and treatment and designates the practice sites where the study is available. The list includes links to a Web site with more details, when available, and can be downloaded onto a physician's computer desktop for easy access.
With 13 locations, Rocky Mountain Cancer Center (Denver, Colorado) also uses e-mail to keep its physicians informed. “Our trial-specific e-mail outlines the specifics of the trials, including information about the significance of the trial, the therapy being studied, and possible [adverse] effects,” says Joni Newman, RN, BSN, OCN, director of research operations for the practice. In addition, the center uses e-mail as a “virtual tumor board,” says Newman, where physicians within the US Oncology Network (Houston, Texas) across the country can discuss specific cases. Oftentimes, trials are brought up through these discussions.
St Luke's regularly updates and distributes its pocket-size book of open trials, and it has also established a password-protected intranet site to provide access to the protocols of the trials. “We set up this site in the same format as the familiar protocol book to increase the ease with which providers transition from the paper copy binders they've been using,” says Harris. St Luke's also prints “Research Report,” a quarterly newsletter that lists newly opened and closed trials. “We distribute the newsletter throughout the Mountain States Tumor Institute system, and we also send copies to practitioners who would have an interest in the newly opened studies and who are potential referral sources,” says Harris.
Marshfield Clinic (Marshfield, Wisconsin) also posts an electronic protocol system on its intranet, making information easily accessible to physicians at eight regional centers where oncology research is conducted. “The system allows providers the ability to search for possible clinical trials for patients in real time and ensures that clinicians and coordinators utilize the up-to-date protocol treatment and patient consent form,” says Tarit Banerjee, MD, of the clinic. The electronic book includes e-mail links to research staff as well as other contact information. The list is updated every two weeks, and to highlight new additions to the book, research staff send e-mails to announce the activation of protocols. Marshfield Clinic also uses advanced technology to reach rural areas, where approximately 75% of its patients reside. TeleHealth video technology (TeleHealth Services, Raleigh, North Carolina) enables physicians and research staff to enroll patients and gain informed consent remotely.
The latest technology is not the only way to get the message out. The Carle Cancer Center supplements its Web-based information with a less sophisticated but effective means to inform physicians about available trials—a “cancer attack board” located outside of the research office that lists every study open to accrual, along with its major eligibility criteria. The board is separated into disease site categories, and for each study, there is a 3-by-5-inch magnetic card with a summary of the protocol.
“At any time, a physician can be found reviewing the board for our current treatment options. Physicians can take the magnetic summary protocol card they are interested in to the clinical research professional to more thoroughly check patient trial eligibility,” says Rowland. “The cancer attack board has been around for more than 20 years in our center. Its name came from our mission to ‘attack’ cancer, and this was our means to do so. Physicians cannot go to other parts of the clinic or hospital without passing by this huge 4-by-16-foot reminder.”