Coordinator advice on how to improve minority recruiting
Site is # 1 in recruiting African American women
Clinical trial professionals who wish to increase minority participation in their studies might learn a few tips from the research outreach coordinator whose enrollment efforts resulted in her becoming the number one accruer of African American women in the national Study of Tamoxifen and Raloxifene (STAR).
"I had to do some very out-of-the-box thinking," says Melinda D. Hudson, RN, CCRC, CCRP, clinical outreach coordinator with Spartanburg Regional Medical Center in Spartanburg, SC.
Hudson enrolled 39 African-American women, who were 15 percent of the total women enrolled in the breast cancer prevention trial, which enrolled about 19,000 women nationally at more than 100 sites.
The five-year STAR trial was one of a number of studies conducted by Upstate Carolina Community Clinical Oncology Program (UC-CCOP) of the Spartanburg Regional Healthcare System, Hudson says.
UC-CCOP was the fourth highest minority recruiter in the SELECT trial, having randomized 197 African-American men from the site, Hudson says.
The STAR trial posed a variety of challenges to sites focusing on minority recruitment, Hudson notes.
"This trial's inclusion criteria was very stringent," Hudson says. "It was based on a woman's risk of developing breast cancer over a five-year period."
The way the risk calculation model worked made it more difficult to find African-American women who met the inclusion criteria because research has shown that African-American women have a lower incidence rate of breast cancer than Caucasian women, although they have a higher mortality rate from it, Hudson explains.
Also, Hudson lives 40 miles away from the Spartanburg community, and so she had to start from scratch in getting to know African-American groups there, she says.
"We definitely wanted to look at this community and population because of research showing that Spartanburg County has one of the highest rates of breast cancer incidence in the state," Hudson says.
"So one thing I did here as a minority outreach coordinator is get to know my community and its history," she says. "I wanted to know what kind of research was done here in the past, what was the community's response, what were the barriers, were the criteria difficult to enroll?"
One key to building trust in a minority community is to show that you'll be there to provide support and answers after the study is complete, Hudson notes.
"So many times the African-American community has seen people come in and recruit for studies and get what they want," Hudson says. "Then when the study is over, there is no lasting commitment."
The STAR trials included this level of commitment to participants, Hudson says.
Here is how Hudson and UC-CCOP achieved success in minority recruitment:
• Meet key people in the community.
Hudson met with key leaders of the African-American women community in Spartanburg, as well as with local pastors, nurses, professional nursing organizations, and other groups.
"I met with leadership councils in this community to find out what kind of health education was being done: what kind of programs worked and what didn't," Hudson says. "I went to churches and spoke, holding health education sessions from the pulpit."
She expanded her recruitment area to beyond Spartanburg and into neighboring counties.
Basically, Hudson let local African-American women know who she was and what she was working on, and she started the outreach as soon as she began to work on the STAR trial, she says.
"Being African American really helped in that sense," Hudson says. "That helped me get to know the African-American community and gave me access to closed and private sessions, as well as access and connections with local leaders."
Hudson also served as a mentor to several other community outreach coordinators who worked on the study.
"Those who were not African American did express some complications as far as building trust and conducting outreach in African-American communities," Hudson notes. "It's not that it can't be done, and I had colleagues who definitely have been able to do this and did it very effectively."
But when clinical trial professionals are trying to gain trust and break through barriers to reach women in the African-American community, it's definitely helpful to be both a woman and of African American descent, Hudson says.
• Stress your health background more than the research.
One of Hudson's strategies when meeting potential study participants was to stress her health care background and her intention to help women in the community improve their own health.
"Being a nurse and also being a clinical research coordinator, I know it's extremely important for minorities to be included in clinical trials," Hudson says. "I don't go into the community pushing clinical trials; I go in educating African-American women about breast cancer."
She would tell women, "I'm here to help increase breast cancer screenings in this area, and I'm here to help you live and not just participate in the study."
UC-CCOP conducted free breast clinics in the community as a strategy to create awareness of the clinical trials and offer health services to identify eligible women, Hudson says.
"We did this monthly so that women would have access to breast services," she says. "The clinic provided clinical breast exams, blood pressure checks, and breast risk assessment counseling."
Women began to see Hudson as their community breast health representative, and so if they found a lump in their breast, they'd call her, or if they needed a mammogram they'd call her, she says.
• Educate the community and doctors about research.
The Spartanburg community needed some basic education about clinical trials, including what is involved in research studies, and how eligibility is determined, Hudson notes.
"So I did educational sessions and forums on clinical trials," she says. "We held informational sessions and seminars to create awareness about clinical trials and breast cancer prevention trials."
Hudson spoke at women's conferences and lunches, and she attended many of these where she was not a featured speaker.
"Sometimes I would be there just to have a presence there," Hudson says. "You need to respect the group's agenda and not push for clinical trials; sometimes you have to be patient and attend a function just to have a presence there that will speak louder than words."
At every function she attended, if she were given permission, she would hand out the STAR trial's risk assessment form. These listed demographic risk factors for breast cancer, and women could fill them out and mail them in to find out if they were at high risk, Hudson says.
Hudson could use the form's information to see which women might meet the study's criteria as being at high risk, and then she could contact the women, thank them for filling out the form, and let them know that they were at high risk.
"I'd invite the woman to come in and have a one-on-one session with me to discuss what the results mean," Hudson says. "I did this with every woman identified as being at high risk with breast cancer."
Once she met with the woman, she'd tell her more about the STAR trial and suggest that she speak with her husband, family, friends, and doctor about it.
"I enrolled about 50 percent of the women doing it that way, taking the personal approach," Hudson recalls.
Hudson also met with OB/GYNs, internists, oncology doctors, community health center staff, family practitioners and other physicians, nurses, and their staffs, educating them about the STAR trial.
These clinicians would then know enough to discuss the trial with their patients should their patients approach them about the study, Hudson says.
"We also met with professional nursing organizations because a lot of community people call their nurses for advice," Hudson says. "We had lunch with them, discussed the trial and gave them opportunities to contact us if there was something we could do for them."
Clinical research coordinators may help improve enrollment if they combine the skills of coordinating, collaboration, and partnering, Hudson says.
For example, for the STAR trial, Hudson coordinated educational efforts with the minority outreach manager of the American Cancer Society, who was conducting seminars throughout the area.
"So we decided that wherever she went I'd tag along, and after she was done she'd give me five to 10 minutes of time so I could speak about clinical trials," Hudson says.
"Additionally, we recruited several women through a partnership with the Best Chance Network — an organization that provides breast and cervical services to low-income women," Hudson says.
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