A conversation with Tom Leuck, BSN-RN
From the Second Quarter 2019 TMIST Study Updates Newsletter
Posted July 2, 2019
Direct phone communications have contributed to a recent doubling of monthly TMIST subject recruitment at the Gibbs Cancer Center and Research Institute at Spartanburg Medical Center (SC024) in South Carolina.
Radiation oncologist Amarinthia Curtis, MD, the trial’s principal investigator in this county of about 300,000 in northwest South Carolina, planned to enroll up to 40 women per month when they began recruitment in December 2017.
The high-volume Bearden-Josey Center for Breast Health, housed in a well-appointed facility attached to the research center and the 540-bed Spartanburg Medical Center, serves enough women to easily meet that goal, but only 18 to 22 subjects per month volunteered while the TMIST staff relied on written invitations mailed to potential subjects.
That all changed when the staff started picking up the phone. Forty-two women signed consent forms in April after the program shifted exclusively to phone recruitment. This brings the site’s total accrual to 312 as of May 22. The program is on track to sign up more than 40 in May.
In an interview with the TMIST team, lead coordinator Tom Leuck, BSN-RN, discussed how direct contact with potential participants and other aspects of their recruitment program have contributed to the sudden improvement in enrollment.
We have a data coordinator and four nurses on the staff. On nearly a daily basis, Lorraine Forrester, our data coordinator, looks at the mammography schedule and initially screens our prospective subjects to make sure they don’t have a history of breast cancer and that they’re eligible to sign up for TMIST. She screens about 125 potential subjects each week and also processes blood and tissue specimens for those women already enrolled in the trial. Our calls are mainly to women who have appointments for screening mammography in the next two or three days. Julie Rakes, RN, makes most of the calls, though Darla Howard, BSN-RN, Shannon Stancil, BSN-RN, and I also call women.
It’s just the way we explain things to women. We all go into this with a positive attitude about the trial. You need to make the person feel comfortable while you explain why we are doing the study and how they can be a part of it. It also helps to have a pretty large team running the trial. We share all the responsibilities of talking with the women, signing them up, and getting all the data in a timely manner.
A lot of the women have said their doctors prefer the tomo over digital mammography. We will explain the whole study to them and its purpose. A lot of the time, when they say their doctor prefers the tomo, we’ll just back off and not pursue that person any longer. Some will ask for our opinion about which machine we think is the best. Of course, we don’t give them our opinion, but they think that because tomo is newer, it must be better. We explain that there is no data that supports that tomosynthesis is better than 2-D digital mammography at reducing the chances for a woman to develop a life-threatening (advanced) cancer. That’s really the whole point of the trial.
We emphasize that this is a large international study, with a plan to involve 165,000 women, so it is going to be a really good study to determine which machine is better at early detection. We emphasize early detection because early detection means better treatment.
A couple of women every week ask for more time to decide. For these women, we ask if they would prefer if we call them back or if they want to give us a call later. We add them to our call calendar if that is what they prefer. We also ask if they want us to email them a copy of the consent form. In that way, the information in the consent form can help guide their decision.
When we are talking to potential subjects on the phone, we mention there are three optional parts of the study. We mention the blood draw and the buccal cell acquisition. We also mention tissue collection, if they have a breast biopsy. We tell them they don’t have to decide today, but when they come in for their mammograms, we will talk to them again. We ask our potential subjects to come in about 20 minutes before their mammogram appointments, so we can sit and talk with them. This gives us time to get them registered into the trial and randomized. A section of the consent form they sign covers the options, which we review with them. Once registered, we’ll then do their blood draws and their buccal cell swab.
We have started some second-round screening because the cancer institute started recruitment in December 2017. We’re using a spreadsheet to track when these women are scheduled for their next appointment. We also have Epic® for our electronic health records (EHR). We have a drop box set up in the EHR that alerts us when women in the trial schedule their next screening mammogram. We will know the exact time and date. We can also check randomization on the EHR to make sure they have the right type of mammogram done.
Editor’s Note to Participating Sites: Through the new quarterly e-newsletter, the TMIST team will continue to bring to 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.