TMIST Team at University of Cincinnati Medical Center Overcomes COVID-19 Challenges
From the Second Quarter 2020 TMIST Study Updates Newsletter
Posted July 23, 2020
The TMIST staff at the University of Cincinnati Medical Center (UC Health), pictured here, is developing new ways to accrue patient volunteers and more safely manage the breast imaging centers where the trial is conducted. The changes come after a mandatory six-week, statewide shelter-at-home order and public responses to the COVID-19 pandemic.
The recruitment program gained 509 accruals from the trial’s August 2018 starting date until the hospital complied with the guidance from the Centers for Disease Control and Prevention to suspend non-urgent care — including screening mammography — at the outset of the COVID-19 pandemic. The University of Cincinnati since required non-critical research staff to work from home until June 1. Even now, they can only come on-site to gain patient consent or perform a limited number of other duties.
TMIST recruitment resumed at UC Health on or about June 15. The staff is working hard to address patient concerns and other enrollment challenges as non-urgent care resumes in Ohio, Kentucky, and many other areas around the country.
In the three weeks prior to the July 4 holiday, TMIST recruitment manager Holly Wilcox, pictured here, issued email invitations to 57 patients. She contacted 19 of those prospects by phone. All were scheduled for routine breast cancer screenings, but none accepted invitations to volunteer. Each person cited their age — 45–74, an enrollment criterion for the trial — as placing them at elevated risk for severe illness and death from the coronavirus.
The response reflects how much work still awaits Dr. Sobel and his team. In addition to Wilcox, the UC Health TMIST team includes Annette Turner Shepherd, manager of UC Health’s two breast imaging centers, and Monene Kamm, UC Health clinical research project manager.
“Recruiting during a pandemic is new to all of us,” Monene Kamm, pictured here, said in a phone interview. “We are learning as we go.”
While non-essential breast imaging was suspended during the shutdown, diagnostic breast scans and procedures were still performed at UC Health’s two breast imaging centers. As with most staff members, Kamm worked from home to answer queries from the ECOG-ACRIN Cancer Research Group’s data management team and to implement remote monitoring for the study. She continued to process blood and buccal samples collected from volunteers before the shutdown, and Wilcox and research assistant Aaron Bloemer caught up on their paperwork from home.
Mandatory safety precautions for patients and staff were implemented as part of a re-entry plan when the breast imaging services reopened on June 1. Facial coverings, body temperatures-taking at building entrances, easily accessible hand-sanitizing stations, frequent disinfection of ‘high-touch’ surfaces, six-foot social distance controls, and work-at-home requirements continue to be enforced for the entire medical center.
“At the breast imaging centers, fewer screening and diagnostic evaluations are scheduled to ensure sufficient social distancing,” Dr. Sobel, pictured here, said. Access to dressing and common rooms is restricted so patients can be isolated in an exam room until the technologist arrives for imaging. Research personnel are allowed in the facilities only to handle enrollment. Follow-up is performed remotely.
The normal recruitment routine was altered because of the work-at-home orders. Wilcox can no longer sit behind the registrar to greet targeted patients upon their arrival and to draw them aside for conversations about participating.
Now allowed to return to the medical center on a limited basis, Wilcox looks for every possible opportunity to reassure women of the mandatory safety procedures and present the trial despite the decreased imaging volume.
“Before the public emergency, a new patient arrived at the breast imaging center every 15–20 minutes during a normal business day,” Wilcox said. After the stay-at-home period, arrivals fell to one every 30–40 minutes. Arriving patients tend to maintain ample social distances to minimize the risk of coronavirus exposure. Still, some patients are too frightened to come to the clinics for routine breast screening.
“That’s the biggest challenge to getting patients to say ‘yes’ to participation,” Wilcox said. “I try to explain to them that we can do as much as possible over the phone. When they come in, we will just have them sign all the paperwork that needs to be signed.”
Wilcox is working with her colleagues to adopt e-consent software to reduce the risk of infection even more. Such cloud-based software can enable patients to consent to volunteer for TMIST or other trials by providing their authorized e-signature from a laptop or cell phone.
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.