Bernyce Edwards was not about to take her daughter's sudden death from breast cancer at age 42 lying down. "It's about as low as a person can get, to lose a child," said Edwards, a retired cashier from Bellingham, Wash., who was anguished by her child's 68-day journey from diagnosis to death.
"I was so angry, but out of that came the determination to do what I could to help find a solution," she said.
Edwards was 67 when she joined the yearlong study at Fred Hutchinson Cancer Research Center, which required participants to work out for at least 45 minutes, five days a week. The study results gave the researchers direct evidence that exercise can affect biology related to cancer and other chronic diseases in older women.
Unbeknownst to Edwards, there was something bigger at play with her participation. Clinical trials — which include studies of healthy individuals like Edwards and new treatments or medications for people who are ill — form the backbone of disease prevention and treatment. The results of such trials guide doctors in the prevention, diagnosis and treatment of illness.
But convincing individuals like Edwards — an African-American woman — to participate in these clinical trials has not been easy, even as researchers across the country have boosted efforts to include people of color in their recruitment goals.
Dr. Gloria Coronado
Public Health Sciences Division
"Certain diseases disproportionately impact communities of color. Cervical cancer, for example, is twice as common in Latinas as in non-Hispanic white women, and prostate cancer is more common in African-American men than in non-Hispanic white men," Coronado said. "Death from most cancers is higher in communities of color. We need more research that addresses these disparities, and in order to successfully carry out this type of research, we need participation from these communities."
Cancer is color-blind. It knows no boundaries. This year, it will strike more than one million people in the United States alone. But for African-Americans, Hispanics and other minorities, it can deliver an especially hard blow.
While data suggest that access to quality care is a factor in cancer disparities, other factors also play a major role, including tumor biology, genetics, hormonal status, lifestyle and behavior, screening policies, the presence of multiple diseases, environmental exposure and risk, quality of and response to therapy, and post-therapy monitoring.
So why don't more people of color participate in clinical trials? Obstacles as well as motivation vary from person to person, but fear of being the subject of experimentation looms large.
"It's a significant barrier that patients view clinical-trial participation as a 'guinea pig' situation," said Dr. Michael Hunter, a radiation oncologist and medical director of the cancer and cancer-research programs at Evergreen Hospital Medical Center in Kirkland, Wash.
The unethical conduct of the Tuskegee Syphilis Study is a blight on the history of clinical trials. The U.S. Public Health Service's 40-year study — which ended in 1972 — documented the effects of untreated syphilis in disadvantaged, rural black men, who were deprived of effective treatment long after it became available.
"Unfortunately, the shadow of that checkered history still resonates with a lot of people in communities of color," said Jo Ann Henderson, an administrative manager who coordinates several Hutchinson Center prevention studies and is a study participant herself.
Today, all organizations conducting clinical trials have institutional review boards — committees of physicians, statisticians, researchers, and community members — which ensure that a clinical trial is ethical and that the rights of study participants are protected. Such boards must approve all U.S. clinical trials before they begin. Additionally, every publicly funded study must have a data and safety monitoring board that oversees the use of therapeutics and practices that have the potential of a risk or harmful effect on study volunteers. Plans must clearly outline the criteria and procedure for stopping the study, if necessary, and reporting requirements.
Clinical-trial organizers who are trying to reach communities of color understand that for some, very basic roadblocks stand in the way of participation. As funding allows, study staff offer help with logistics like transportation and child care. In many cases, researchers take studies to the community, conducting classes or blood draws at neighborhood centers, local churches or community health clinics.
For example, Sea Mar Community Health Centers, which specialize in health and human services for Latinos in Washington, are currently partnering with Hutchinson Center researchers on a study to determine strategies to increase compliance with basic colorectal-cancer screening.
"Our patients have low rates of screening, so we want to find out through this research how we can increase that. If this works, we can apply that knowledge and help keep our patients healthier," said Dr. Ricardo Jimenez, Sea Mar's medical director.
"We are service-oriented, so we have very little time, money, energy or resources for research. Partnering with researchers at the Hutchinson Center and the University of Washington really fills this need. And it helps to overcome cultural and language barriers because we're using the staff and resources that are already familiar to the patients. It's a nice way to approach it, so it doesn't feel like someone is imposing this on our community," Jimenez said.
Complex and interrelated factors contribute to the observed disparities in cancer incidence and death among racial, ethnic and underserved groups. The most obvious factors are associated with a lack of health-care coverage and low socioeconomic status.
Although cancer deaths have declined for both African-Americans and non-Hispanic whites, African- Americans suffer the greatest burden for each of the most common types of cancer. For example, while non-Hispanic white women have the highest rate for breast cancer, African-American women are most likely to die from the disease. African-American men have the highest rate of prostate cancer in the United States and are more than twice as likely as non-Hispanic white men to die of the disease.
Recent National Cancer Institute population studies found that American Indian/Alaskan Native men from the Northern Plains region and native women from Alaska and the Northern and Southern Plains regions had higher cancer-incidence rates than non-Hispanic white men and women in the same areas.
The native communities were more likely to live in poverty and less likely to have a high-school education and health coverage when compared to non-Hispanic white people, all indicators of less access to cancer-prevention and control services. Also, smoking and obesity rates were high among the native populations, and screening rates for breast, colorectal, prostate and cervical cancers were lower.
A similar report found Latinos had lower incidence rates than non-Hispanic whites for most cancers, but were less likely than non-Hispanic whites to be diagnosed with early stage disease for lung, colorectal, prostate, breast and cervical cancers. Latino children have higher incidence rates of leukemia, retinoblastoma, osteosarcoma and germ-cell tumors than non-Latino white children.
Several cancer sites with higher incidence rates in Latinos often have infectious origins: human papilloma virus in cervical cancer, Helicobacter pylori in stomach cancer, and hepatitis B and C in liver cancer.
However, researchers also understand that it's not enough to conduct clinical trials in communities of color. For such studies to be effective and gain acceptance, study personnel must understand the cultural context of the participant population.
For example, when developing health interventions for Latinos, study leaders take into account possible elevated exposures to environmental risk factors in Latinos' homes and work places; lower education, health literacy and income; limited English proficiency; reduced use of screening services; limited access to health care, often due to lack of insurance; and less information available regarding genetic predisposition to cancer.
Since 2002, the Hutchinson Center and New Mexico State University have run a program to increase cancer-research capacity at the university while increasing cancer health-disparities research at the Center. Approximately 150 New Mexico State students — most of them Latino — have been exposed to cancer-research methods and careers through summer internships and guest lectures.
"For students to do science among people like themselves can be very powerful," Coronado said. "And it gives parents a vision of research so they can understand how it is relevant to their lives."
When Coronado and New Mexico State collaborators led a study in New Mexico examining impediments to colonoscopy screening among Latino patients, they learned that follow-up care — especially in communities with a large percentage of undocumented workers — is difficult. Some of these workers fear deportation if they seek medical care. Those concerns are especially high in colonias, rural communities located along the Mexican border that often lack infrastructure and basic services.
The school is starting a new study in the colonias to increase cervical-cancer screening rates. Having researchers of color conduct such research helps, but it isn't the full picture, said Dr. Mary O'Connell, co-principal investigator of the Building Minority Cancer Research Capacity project, the collaboration between the Hutchinson Center and New Mexico State. "Someone from the community is more likely to have productive conversations with members of their own community," she said. "But you can't paint it so black and white. Simply being Hispanic may not make you aware of the issues and complexities of life in that community. Really understanding the situation is more important than the race of the researcher."
Henderson and her mother, Evalena Hatcher, of Seattle, have both participated in research studies, and they found the experiences rewarding.
"We happen to be people who are interested in what medical science is doing," Henderson said. "We don't want to be left out of anything. We really want to hear and be able to see the results firsthand, and while our contributions may not directly benefit us at this point, they could benefit someone who is very close to us at some point in the future."
Jo Ann Henderson, right, with her mother, Evalena Hatcher
Edwin Sedan, a technical designer from Kent, Wash., is one of those people helped by the knowledge gleaned from clinical trials. When he first noticed he was losing hair, he brushed it off as nothing more than an early sign of aging. But when handfuls of hair began falling out, he paid a visit to his family doctor. What he discovered stunned him.
"I thought a prescription for Rogaine would cure my problem," said Sedan, who is Filipino. "Instead, I found out that I had chronic myeloid leukemia."
To stay alive, he needed a stem-cell transplant, the only known cure for his disease at the time. Luckily, Sedan quickly found a matching donor in his only sibling. But tests revealed that he had liver complications that would make the transplant too risky.
Dr. Christopher Li
Public Health Sciences Division
"The mini-transplant clinical trial was my very last option," he said. "I'm grateful to the doctors — and my sister and wife — who made it a successful one."
Dr. Christopher Li, a Hutchinson Center epidemiologist, stresses the importance of clinical-trial participants like Sedan.
"If we don't have adequate representation in trials from communities of color, then we won't know how effective new treatments are in these groups, and whether there are risks or benefits that may impact various racial/ethnic groups differently," he said.
Dr. Michael Hunter
"Minorities and underserved communities, especially African-Americans and those living in rural areas, have very low rates of clinical-trial participation," he said. "Given that the cancer-death burden falls disproportionately on African-Americans, we people of color need to step up and change that situation. It is, quite frankly, unacceptable."