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Cancer Project Enhances Minority Participation in Clinical Trials

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African-Americans are more likely to be diagnosed with certain forms of cancer and are far more likely to die of the disease. But, they also are less likely to enroll in cancer clinical trials, with African-Americans accounting for just 2.5 percent of participants nationwide.

Investigators from Meharry Medical College and Vanderbilt-Ingram Cancer Center, Nashville, Tenn., have just completed a multi-year recruitment trial in which 68 percent of those minority patients eligible for a clinical trial agreed to participate. The dramatic increase in enrollment was the result of direct intervention, which included identifying barriers to enrollment and developing programs to eliminate those barriers. The results were reported during the annual American Association for Cancer Research conference in Denver, Colo.

Barriers included missed appointments, lack of transportation, inadequate insurance, miscommunications and lack of patient understanding. Those barriers were identified during the first year of the study and program procedures were adjusted during succeeding years to address them. Investigators developed a model of care that screened every newly diagnosed patient and identified those patients eligible for a clinical trial.

In 2000, the investigators established a clinical trial shared resource at Nashville General Hospital at Meharry. Most of the patients at this facility are under and uninsured and 55 percent are African-Americans.

“We discovered that these minority patients were just as interested in clinical trials, but they were more likely to have logistical barriers that made enrollment difficult,” said Debra Wujcik, R.N., Ph.D., lead author and director of Clinical Trials at Meharry.

Physicians were advised if a clinical trial was available and a plan was developed to address obstacles such as transportation or medications. Patients were navigated through the clinical trial system with the help of a nurse navigator and a research nurse. During the first reporting period 2001-2004, 569 patients were screened, 164 (29 percent) had a study available and 95 (17 percent) went on study.

However, 58 percent of patients offered a study agreed to participate. Of patients who did not go on study, 66 percent were ineligible because of co-morbidities like diabetes or hypertension, and only three percent refused to participate in a research trial.

In the next reporting period 2005-2007, 556 were screened, 179 (32 percent) had a study available, and 138 (25 percent) agreed to participate. Since 2001, 1125 patients have been screened, 343 (30 percent) had a study available, and 233 (21 percent) have enrolled. Overall, 68 percent of those eligible for a study agreed to participate.

Of those on study during this period, 61 percent were African-American, 36 percent Caucasian, 2 percent Hispanic and 1 percent Pacific Islander.

“Our model for successful clinical trial recruitment of minority and medically underserved patients includes permanent research staff that are fully integrated into the clinical program, a prospective approach and adequate resources that include a patient navigator,” said Wujcik.

“Clinical trials are discussed with the patient during the first conversation about treatment. The trial is not offered as an afterthought and patients do not have to go to another center to go on trial. They can participate in a trial in their own cancer center and be cared for by the staff and doctor they know.”