September 04, 2019

New Strategies Move TMIST Clinical Trial Closer to Accrual Goals

With its expansion to international sites and adoption of new patient recruitment techniques, the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) is moving closer to reaching its ambitious recruitment goals.

Elodia Cole, American College of Radiology (ACR) senior clinical project manager and liaison to the ECOG-ACRIN Cancer Research Group, the trial’s sponsor, laid out this success at a breakout session at the recent National Cancer Institute Community Oncology Program (NCORP) Annual Meeting.

Cole reported that ACR Chief Research Officer and TMIST Principal Investigator, Etta Pisano, MD, FACR, and her team have tripled the number of patients enrolled and increased the number of sites opened and accruing patients by 50 percent over the past eight months.

The trial still needs to recruit more sites to reach the desired 130 facilities, but 88 of the 178 sites that expressed interest in TMIST when it was first announced have either opened the trial or are close to formal participation.

Social media and direct email campaigns directed to radiology department administrators and section chiefs beginning in November 2018 are reaping benefits, Cole noted. Thus far, an additional 45 potential sites identified from these efforts are at various stages of completing the qualification steps toward joining the trial.

Marketing efforts revolving around the potential financial benefits of TMIST participation, outlined in this video, have attracted interest from non-academic, community-based women’s health services.

In addition, TMIST organizers, with support from the ACR, initiated a direct email campaign in July 2019 to recruit more international sites in various countries. Pisano is scheduled to conduct informational sessions October 4 at the European Society of Breast Imaging Annual Scientific Meeting in Budapest and April 9, 2020 at the Global Breast Cancer Conference 2020 (GBCC 2020) in Seoul, Korea.

Some existing sites are adopting strategies to increase patient interest in participation. More resources are being devoted to subject identification and direct contacts between staff members and potential volunteers scheduled for routine breast cancers screening with tomosynthesis or digital mammography.

For individual sites, Cole suggested designating specific blocks of research coordinator time dedicated to recruitment and enrollment and trying different recruitment strategies if current approaches don’t work. When possible, she suggested leveraging electronic medical record pre-screening to focus recruitment staff time on the most likely eligible patients.

Facilities can apply for a $30,000 reimbursement advance to offset the launch of the trial at their site and pay for such RA time.

Representatives from successful TMIST sites also described their experiences.

  • Betsy Barnick, manager of clinical research at Carle Foundation Hospital, Urbana-Champaign, IL, reported on the strategies the Carle Cancer Center has used since September 2017 to persuade 905 women to participate in TMIST. The program adds an average of 41 new participants per month.

  • Eileen Mederos, RN, program manager of NCORP Clinical Trials at Louisiana State University Medical Center, New Orleans, described how her program has recruited an average of 48 subjects per month since November 2018 to add 385 women overall to TMIST.

  • Amarinthia (Amy) Curtis, MD, a radiation oncologist and principal investigator for the TMIST site at the Spartanburg Medical Center in South Carolina, discussed her team’s use of direct phone calls to stir interest in the trial among women scheduled for screening mammography. The Spartanburg program has recruited 399 volunteers for TMIST and is adding an average of 21 women per month to the program.

TMIST is the first large randomized controlled trial (RCT) that seeks to identify women in which digital breast tomosynthesis (DBT) may outpace two-dimensional (2D) digital mammography at reducing advanced breast cancer development. TMIST will also create the world’s largest breast cancer biorepository.

Visit acr.org/TMIST to find out how and why your practice should take part in the largest randomized controlled breast cancer screening trial in decades.

Email TMIST@acr.org with any questions you may have about TMIST.