No Secrets about the Success of Enrolling African American Women at Boston Medical Center in TMIST
From the First Quarter 2020 TMIST Study Updates Newsletter
Posted April 16, 2020
Michael Fishman, MD, the Principal Investigator for the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) at Boston Medical Center (BMC), believes there is no secret to his team’s success in accruing 740 women since their February 28, 2019 start date. BMC currently ranks seventh in accrual among all TMIST sites. More than half (53 percent) of the women participating in TMIST at BMC are African Americans because they comprise a large part of the local population. “BMC, the largest safety-net hospital in New England, strives to provide exceptional medical care for all patients,” Fishman, pictured at left, said in an interview.
Fishman came to BMC in 2018 and remembers seeing more cases of locally advanced cancer in his first six months than in his previous 10 years of radiology practice. He arrived eager to implement TMIST and save lives by encouraging more underserved women in Boston to get regular screening mammograms. His passion for breast imaging is fueled by his mother’s passing from breast cancer.
“Though population dynamics are part of the story, the impressive accrual rate of African American enrollment for TMIST at BMC also stems from our skilled and compassionate staff,” Fishman said.
The BMC program’s performance mainly revolves around the efforts of Samhita Joshi, BDS, MPH, according to Fishman. Until recently, Joshi, pictured at left, was TMIST’s sole clinical research coordinator (CRC) and patient recruiter. She handles all aspects of accrual, from pre-screening eligible patients to recruiting, registration, data entry, image submission, specimen collection/processing, and follow-up.
Joshi’s job requires a huge commitment of time and energy. On a typical day, she will screen the clinic schedule, comprising about 100 to 120 patients, with 40 to 45 appointments involving screening mammography. Joshi divides her mornings into a series of 20-minute appointments with 10 to 15 women who meet the trial’s enrollment criteria.
She has reached out to these women in standard appointment reminder phone conversations to inform them about the study and gauge their interest in discussing at their appointment. Such meetings typically result in three to five or more prospects per day. Joshi helps women complete their informed consent forms and documents their medical histories. After randomization, Joshi hands the patient off to a technologist who escorts her to an imaging suite for the screening exam.
Dr. Fishman knew that Joshi would succeed in her role since joining the trial staff 18 months ago. It was apparent in her open style of communication with research and radiology directors, as well as interactions with the front desk staff, schedulers, quality control technologists, and radiologists. He noticed that she made sure everyone was on the same page about how the accrual protocol would work and how it would avoid disrupting the regular imaging routine.
Salli Fennessey, BS, CCRP, pictured at left, is the Administrative Director of operations for BMC’s Cancer and Hematology Clinical Research Program. She oversees TMIST and trains personnel, drawing from 28 years of institutional knowledge managing clinical trials at BMC.
Fennessey stresses the need for accurate, up-to-date records. “It is really important, especially with this study, where we’re enrolling so many patients,” she said in an interview. “If we get behind on any one thing, we’ll have difficulty catching up when dealing with hundreds of patients, so we have oversight to make sure everything is completed on a timely basis.”
She trains research coordinators and research nurses to recognize the unique needs and limitations of underserved individuals. “Managing the accrual process for African Americans and other minority women requires culturally sensitive skills,” she noted. Many women have not been offered 3-D mammography before, or the opportunity to participate in a clinical trial. “Registration will take longer, but that doesn’t matter. We’re making sure we provide these patients the opportunity to be in the trial.”
Margaret LaVoye plays an essential role as BMC’s Director of Radiology Research Operations. It is her job to navigate around potential obstacles before they affect the reliability of data collection.
The team has streamlined the daily timing of TMIST registration. They avoid it between 11:30 am and 1:00 pm to prevent bottlenecks during the lunch hour. They stop at 6:00 pm to ensure they complete all scheduled exams by the end of the day.
Early on, the team invested more effort into quickly informing technologists about a participant’s enrollment and the results of randomization. They learned to avoid erroneously transporting patients into non-QC’d imaging rooms or performing 2D mammography when randomized to 3D.
When enrolling non-English-speaking patients, they ensure the availability of appropriate documentation. They are allowed to use the short consent form for rarely seen languages, but BMC policy requires them to translate the full consent document for languages seen more frequently (greater than three people).
Based on the program’s success with a single clinical research coordinator, Dr. Fishman and staff hired Hannah Wollman as a second CRC in late 2019. As a team, Joshi and Wollman quickly increased accrual by more than 50 women per month. Their positive experience was short-lived, however, with the COVID-19 pandemic’s arrival causing BMC to shut down the trial temporarily.
There may be much more to say about BMC’s success with TMIST in the future, but that story must wait until the COVID-19 emergency is over.
Editor’s Note to Participating Sites: Through the quarterly newsletter, the TMIST team brings you strategies and tactics that you might consider implementing at your own institution. We strongly encourage all TMIST site physicians and staff to consider submitting your own experiences for this regular series of helpful articles. If interested, please send an email to the TMIST staff.
TMIST is publicly funded by the National Cancer Institute (NCI), part of the National Institutes of Health, through the NCI Community Oncology Research Program.