Experts to present data addressing patient and physician barriers to clinical trials

(Press-News.org) Researchers from University Hospitals Case Medical Center's (UHCMC) Seidman Cancer Center in Cleveland, OH, will present findings from two studies evaluating new technologies designed to address common barriers to patient enrollment in clinical trials. Results from a large-scale, randomized trial demonstrated that the use of tailored, web-based videos delivering educational information to patients before an oncologist visit can significantly improve knowledge and reduce attitudinal barriers that impact enrollment in clinical trials. A second, preliminary study showed that a new automated technology created by UHCMC researchers helped oncologists identify clinical trials for individual patients in a busy outpatient oncology clinic.

"Although clinical trials are the key to developing new, better cancer treatments, less than 10 percent of cancer patients participate in them," says Neal J. Meropol, MD, study author, Chief of the Division of Hematology and Oncology at UHCMC and Case Western Reserve University School of Medicine and member-elect of the ASCO Board of Directors. "We know there are multiple barriers to clinical trials for both patients and oncologists, and the new technologies being evaluated at University Hospitals Case Medical Center Seidman Cancer Center are designed to break down those obstacles by providing individualized education for patients and new technology to help oncologists efficiently identify appropriate trials for their patients."

Common barriers to patient enrollment in clinical trials include fear of side effects, receiving placebo instead of treatment, financial concerns and the misperception that clinical trials should only be considered as a "last resort" option. For oncologists, a common obstacle is the time needed to help identify appropriate clinical trials – thousands of which are currently in progress across the country – for their patients. At the UHCMC Seidman Cancer Center, there are currently more than 300 ongoing clinical trials focused on cancer.

About the Studies

Oral Abstract Session: Health Services Research
Randomized Trial of a Web-based Intervention to Address Barriers to Clinical Trials
Abstract #6500: June 3, 8:00 – 8:15 a.m.

Dr. Meropol will present findings from a trial examining the use of PRE-ACT – Preparatory Education About Clinical Trials – a tailored, interactive, web-based intervention to address patient barriers and improve preparation for consideration of clinical trials as a treatment option. The prospective, randomized, multicenter, Phase 3 clinical trial evaluated 1,255 patients and utilized baseline assessments to determine their top clinical trial barriers. Patients in the PRE-ACT group were presented with a video library of 30-90 second clips that addressed their individual barriers, as indicated by their assessment results. Patients in the control group received online, text-based information that wasn't tailored to their individual barriers. A follow-up survey was conducted to reassess patient knowledge and attitudes.

Results showed that PRE-ACT significantly improved patient understanding and attitudes towards clinical trials when viewed before a visit to an oncologist. The control group also had improved knowledge, reduced attitudinal barriers and improved preparation, but the PRE-ACT group was more satisfied with the amount and format of information presented to them and felt more prepared to consider enrollment in clinical trials when compared to patients who received written information.

Funding for this study was provided by a National Cancer Institute (NCI) grant (R01CA127655) to Case Western Reserve University School of Medicine.

General Poster Session: Health Services Research
Trial Prospector: An Automated Clinical Trials Eligibility Matching Program
Abstract #111482: June 3, 1:15 – 5:00 p.m.

Co-authors Andrew Parchman, MD, Hematology and Oncology Fellow at UHCMC, and Dr. Meropol will present findings examining the use of Trial Prospector – an automated, HIPAA-compliant program pioneered by UHCMC that matches patients to clinical trials based on information extracted from their electronic medical records. Its user-friendly interface allows for physician perusal of relevant clinical trials and eligibility checklists at the point of care without requiring manual data entry. For this study, pilot testing was performed in a GI oncology subspecialty clinic. Eleven oncologists completed surveys after each patient visit to assess the usability and impact of Trial Prospector.

Results showed that the Trial Prospector matching algorithm was 100 percent accurate and saved time identifying potential clinical trials. Physicians generally found it to be easy to use, and 90.9 percent said they would recommend its use for clinical trial eligibility screening. Based on these preliminary findings, Dr. Parchman and team intend to expand data elements to increase the precision of trial matching and expand to other disease specialties and practice locations.

Funding for this study was provided by the Clinical and Translational Science Collaborative of Cleveland, UL1TR000439 from the National Center for Advancing Translational Sciences (NCATS) component of the National Institutes of Health and NIH roadmap for Medical Research to Case Western Reserve University School of Medicine.

### About University Hospitals University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians. At the core of our health system is University Hospitals Case Medical Center. The primary affiliate of Case Western Reserve University School of Medicine, UH Case Medical Center is home to some of the most prestigious clinical and clinical research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopaedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated UH Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. For more information, go to UHhospitals.org.