PROTOCOL GOG 0233/ACRIN 6671
Oklahoma University Research Personnel Share Accrual Insight
As mentioned in the January e-update for this protocol, the pace of patient enrollment has been below expectations. In an effort to identify and share techniques that research sites find successful in boosting accrual for GOG 0233/ACRIN 6671, ACRIN administrative staff recently interviewed research personnel at the Oklahoma University Health Sciences Center (OUHSC). Deborah Wright, research nurse navigator; Ingrid Block, GOG Research Associate; and Ken Wegner, Radiology Research Associate were happy to offer their thoughts on the institutional and procedural factors that have helped them to briskly enroll patients in this study.
Both Deborah and Ingrid view the proactive research culture at OUHSC, in which both faculty and physicians are supportive of its integral role, as a distinct advantage in facilitating clinical trial enrollment. According to Deborah, the process of encouraging patients to consider participating in clinical studies at OUHSC begins with “our first encounter with the patient,” when the long-term benefits of doing research are explained and consenting for multiple complementary protocols may be initiated. “Educating patients is key. The more information they have, the more they participate.”
Gynecologic oncologists at OUHSC, who drive enrollment, regularly consent patients early on for multiple studies, including participation in the cervical cancer lymph node study (GOG 221) that is complementary to the GOG-ACRIN trial. Also, the fact that the surgical treatment required by GOG 233/ACRIN 6671 is already the standard of care for cervical cancer at OUHSC, with imaging being the only experimental components, has also made it easier to recruit patients for this protocol. Consent is most often obtained in the clinics at the time of cancer staging. Deborah and Ingrid emphasize that the enthusiastic and positive attitudes of the physicians in describing the potential for improving future cervical cancer treatment have been extremely effective.
Another primary factor in OUHSC’s successful enrollment rates has been its emphasis on a tightly coordinated protocol team, expansively defined to include all those involved on the GOG side (gynecologic oncologists, research nurses, and data management team) as well as the imaging side (the MRI and PET physicians, research development specialist, chief technologists for the various imaging modalities, and the administrative staff). Ken believes it is critical for this team to convene “as soon as the study is set up (before any patients are enrolled) to discuss expectations of the various departments” and facilitate coordination of their functions.
Communication between the GOG and ACRIN research teams is essential, especially given the particular challenge of scheduling and completing the MRI and PET/CT scans in the sequencing required by this protocol. To this end, Oklahoma research personnel have developed several documents to aid study coordination, such an “order template” that notifies radiology to expect patients, for ordering outpatient infusion of contrast agent and for scheduling the imaging scans. Also an “infusion flow sheet” has been developed that details the contrast administration process. Fortunately, research personnel have agreed to share their specialized materials with other GOG-ACRIN sites.
The documents developed by the OUHSC research team are on the ACRIN Web site at: http://www.acrin.org/PROTOCOLSUMMARYTABLE/PROTOCOL6671/6671RecruitmentandEducationalMaterials/tabid/418/Default.aspx .