Amarinthia Curtis has a community doctor’s perspective on the scientific questions the Tomosynthesis Mammographic Imaging Screening Trial seeks to address.
The first of these questions is whether digital breast tomosynthesis is better than digital mammography in reducing development of advanced breast cancer.
“We are gathering more granular demographic and socioeconomic data about women eligible to participate in TMIST—both those who enroll and those who choose not to enroll,” said Curtis, a radiation oncologist at the Spartanburg Medical Center, part of Southeast Clinical Oncology Research Consortium NCI Clinical Oncology Research Program site. “I’m excited that in addition to helping tailor breast cancer screening, we will also know who participates in clinical trials and what barriers prevent others from doing so.”
Curtis’s site is one of the top accrual centers to the large, international early detection trial. The randomized trial (study EA1151; NCT03233191), led by ECOG-ACRIN Cancer Research Group, seeks to screen 165,000 women.
Over 12,000 women are enrolled at 71 mammography clinics so far, and the pace is accelerating. The trial added 16 new sites over the past three months, as a result of a robust marketing effort. Recruitment of sites will continue aggressively until at least 130 locations are open.
“Women are very intrigued by the many questions asked by the study,” Curtis said. “Inherently, they know that their lives, their diets, their habits and exposures are different than their mothers’.
“They also know that their daughters’ lives are different.
“They want studies that ask if the old rules still apply. TMIST is more than simply a technology study, and we try to emphasize that message. While some women choose not to participate because of their preference for 3D mammograms, we’ve been impressed by the large number of women who are enthusiastic.”
“We have had hospital employees, hospital donors, and family members of cancer patients participate in the trial,” Curtis said. “Many of these women are telling our coordinators how proud they are that our hospital is participating in this study and that they can enroll.
“Many women seek additional ways to express their breast cancer advocacy, and participating in TMIST has been a great fit for these women.”
The conversation with Curtis is part of an informal series of interviews and guest editorials focused on TMIST.
The other articles are:
A conversation with Etta Pisano, the PI of the study, chief research officer at the American College of Radiology, a radiologist at Beth Israel Deaconess Medical Center, and a professor in residence at Harvard Medical School (The Cancer Letter, March 15).
Commentary by Worta McCaskill-Stevens, chief of the Community Oncology and Prevention Trials Research Group, director of the NCI Community Oncology Research Program at the Division of Cancer Prevention. As an NCI official, McCaskill-Stevens was a part of the planning effort to design and launch the trial. “Today, as a woman and a person of color, I have the opportunity to contribute on a much more personal level” by enrolling in the trial, she wrote in the guest editorial (The Cancer Letter, May 24).
Point-counterpoint discussion of overdiagnosis in the context of trial design for breast cancer screening (The Cancer Letter, May 3 and May 10).
Curtis spoke with Paul Goldberg, editor and publisher of The Cancer Letter.
Paul Goldberg: How is your site’s accrual to TMIST going? Is it more challenging than other trials?
Amy Curtis: We are accruing about 40 participants a month (2-3 per day, 4 days a week). It is the highest accruing trial in our portfolio, and it has helped us to be one of the top accruing NCORP sites for the trial.
Accrual to TMIST has been less challenging than most of the studies in our portfolio. There are far more women eligible for the study than we can reach each week. Among the women we do reach, there is great enthusiasm for participating!
Where are you in terms of targets? Are you at the pace you want to be?
AC: We are short of the target of 3-5 per day set by TMIST, but are consistently at 10-12 per week. For internal budgeting we had a target of 20 per month and we have vastly exceeded that. Our TMIST team meets regularly to see what we can do better, and we are hopeful that we can achieve the study target.
How do you present this trial to potential participants? Are women intrigued by this research question? Is it difficult to explain to them that there is equipoise here, that more sensitivity doesn’t necessarily equal greater benefit?
AC: We first present the trial with a letter provided by the ECOG-ACRIN Clinical Education and Awareness team and approved by the cIRB.
About 2-3% of our participants call us to enroll after receiving the letter. A portion of the remaining women are called. Our research coordinator starts the call by reminding the woman of her mammogram date and time and then asks if she has received the letter.
In our experience, women who have read the letter are more open to participating than women who have not. Our coordinators then discuss the study and the practical aspects of participating.
Women care a great deal about the detection of breast cancer and have been eager to participate. In terms of numbers, our hospital system performs more than 500 screening mammograms a week.
When we narrow down to our study site and filter for eligible women, we send out about 100 letters a week. We are able to call about 20-30 of those women (limited by staff time). Anywhere from a third to a half of the women we call decide to participate.
Women are very intrigued by the many questions asked by the study. Inherently, they know that their lives, their diets, their habits and exposures are different than their mothers’.
They also know that their daughters’ lives are different.
They want studies that ask if the old rules still apply. TMIST is more than simply a technology study, and we try to emphasize that message. While some women choose not to participate because of their preference for 3D mammograms, we’ve been impressed by the large number of women who are enthusiastic.
What are some recruitment strategies that you are using right now?
AC: We primarily use the letters and calls described above. We periodically have a banner on the hospital’s internal webpage that has led to 8-10 new participants and improved awareness of the trial among employees.
We have reached out to primary care offices and worked with our marketing department. These efforts have improved awareness, but have not yet led to direct referrals/accruals.
Are there any best practices for managing this trial that come to mind?
AC: Here are my top tips:
Having dedicated staff improves efficiency and quality.
Our TMIST team meets regularly to address any issues that come up, share ideas and benchmark against internal and external accrual numbers. Benchmarking with the leading centers has motivated our team.
Stay organized and make the Electronic Medical Record your friend. Investing some time upfront to know all the EMR tools, really helps.
Make some calls in the evenings—women are more likely to have a few minutes to talk.
Have a way to send the consent form ahead of time so a potential participant has plenty of time to review and think things over without disrupting her day or the workflow of the mammography center.
Put together a “TMIST business plan” for site administration and finance departments. The model for this trial is so different from typical cancer center trials that it is important to show how the trial is supported.
I hear that some sites are reluctant to get involved in this trial for a variety of reasons, such as the need for resources or just priority-setting at the sites. Have you encountered this?
AC: Even our site was reluctant at first. Our radiologists and administration had questions.
Dr. Etta Pisano, the principal investigator, offered to discuss the trial, so we set up a meeting with our hospital’s stakeholders including research staff, radiology, IT, and administration.
She called in, along with ECOG-ACRIN staff, and answered questions about the science and the practicalities of the trial. I encourage any site who has questions to avail themselves of this same opportunity.
Have you encountered any barriers to this trial and if so, how are you addressing them?
AC: At this point, most of our barriers are logistics. While women are enthusiastic about participating, they are usually trying to fit their mammogram into a busy day.
Consent, specimen collection, randomization, and the actual mammogram can take some time.
After speaking with a woman on the phone who has preliminarily said she will participate, we try to send the consent form electronically or by mail, so she can read it ahead of time.
This saves time on the day of enrollment. Another barrier is space in our imaging department—there just aren’t a lot of empty rooms. When the ultrasound room is open, our coordinators like to use that for all study activities, because it is private and has a sink and sharps disposal. Otherwise, we use different rooms for different study activities.
Is there a need for a culture change in radiology, so that it would encompass a greater appreciation for randomization?
AC: American medicine tends to idolize the newest technology, so this is far from a radiology issue.
We have a Catch-22 with screening studies. Since screening studies must be so large to detect meaningful differences, the newer technology must be available at a large number of sites.
However, once there is a critical mass of that technology, it is hard to question those investments.
I think radiologists, researchers, and women themselves appreciate that this isn’t simply a study of 2D vs 3D, but how we best use all of our current tools. Can we be more personalized in our screening approach?
What have we learned from lung cancer screening that might be applicable to TMIST? You remember IELCAP, these massive single-arm studies. But it took NLST to change policy. And now, the uptake of lung screening is low. Are there any parallels here?
AC: The lessons learned from the lung cancer screening trials helped with study practicalities and reinforced the importance of a randomized rather than single arm design.
Breast cancer screening has been a huge part of women’s healthcare in a way that lung cancer screening hasn’t been. I’m optimistic that the results from TMIST will inform screening recommendations and, in turn, those will be fairly rapidly implemented.
Is there anything else, anything we need to know that I didn’t ask?
AC: In addition to the scientific benefits of conducting this research, we have seen tremendous community benefits.
They want studies that ask if the old rules still apply. TMIST is more than simply a technology study, and we try to emphasize that message.
We have had hospital employees, hospital donors, and family members of cancer patients participate in the trial. Many of these women are telling our coordinators how proud they are that our hospital is participating in this study and that they can enroll.
Many women seek additional ways to express their breast cancer advocacy, and participating in TMIST has been a great fit for these women.
Additionally, as an NCORP site, we also are able to participate in DCP-001—“Use of a Clinical Trial Screening Tool to Address Cancer Health Disparities in the NCI Community Oncology Research Program.”
We are gathering more granular demographic and socioeconomic data about women eligible to participate in TMIST—both those who enroll and those who choose not to enroll. I’m excited that in addition to helping tailor breast cancer screening, we will also know who participates in clinical trials and what barriers prevent others from doing so.
