Roxanne Nelson

June 11, 2013

CHICAGO — Clinical trials are the key to developing new and better cancer treatments, but there are barriers to physician and patient participation. In fact, only a small percentage of patients — less than 5% of all cancer patients — actually participate.

Two studies aimed at knocking down those barriers were presented here at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO®). One was designed to educate patients and the other addressed barriers from the physician standpoint.

The patient-education study, known as PRE-ACT (Preparatory Education About Clinical Trials), addresses some of the common barriers that prevent patients from enrolling in clinical trials.

"Its overall objective is to recognize the barriers that individual patients have when considering a clinical trial, whether it is a lack of knowledge or awareness of clinical trials or whether its an attitude about clinical trials," said Neal J. Meropol, MD, chief of the division of hematology and oncology at University Hospitals Case Medical Center and Case Western Reserve University School of Medicine in Cleveland, Ohio, who was involved with both studies.

"They fear randomization or fear getting a placebo," Dr. Meropol told Medscape Medical News. "By addressing the individual barriers that patients have about clinical trials, we can better prepare them to consider appropriate clinical trials."

The Value of Video Clips

In the phase 3 multicenter trial PRE-ACT study, a tailored, interactive, Web-based intervention was used to address patient barriers and improve preparation for consideration of clinical trials as a treatment option.

Dr. Meropol and colleagues assessed 1255 patients to determine the top clinical trial barriers.

Before the initial oncologist consultation, all patients completed a baseline assessment that evaluated knowledge of clinical trials, attitudes about clinical trials, preparation for decision making, and preferences for shared decision making and quality and length of life.

Patients randomized to the PRE-ACT group received a summary of their preferences and a list of their primary barriers to clinical trials. They were then shown a series of 30- to 90-second video clips to address each of their barriers, Dr. Meropol explained.

Patients randomized to the control group received generic text information about clinical trials. "It was very high-quality information from the NCI Web site, but not tailored to the individual patient," he said.

In both groups, knowledge improved, attitudinal barriers decreased, and preparation improved (P < .0001 for all). However, in the PRE-ACT group, the improvement in knowledge was greater, attitudinal barriers decreased to a greater extent, and there "was a trend toward better preparation, although it didn't reach statistical significance." Dr. Meropol reported that patients in the PRE-ACT group "were more satisfied overall in how the information was conveyed to them."

We hope "this will lead to increased enrollment in clinical trials, but we haven't analyzed those data yet. Those are more complicated data to assess because they involve so many other external factors," he noted.

Practical Solutions for Busy Oncologists

The second study addressed barriers from the physician standpoint. "One of the problems that physicians have is a practical one," Dr. Meropol told Medscape Medical News. "It takes time out of a busy practice to discuss clinical trials, to find out if a patient is eligible, and so on. It interrupts the flow of your practice. That keeps them from participating in clinical trials," Dr. Meropol said.

To address this issue, a multidisciplinary team developed the Trial Prospector (TP), which is an innovative and flexible computer-based system that automatically extracts information (such as demographic characteristics, pathologic diagnosis, disease stage, lab results) from multiple clinical data systems and then matches it to clinical trial eligibility criteria.

The interface is very friendly, explained Dr. Meropol. "At the point of care, without the physician having to enter in any information, he or she is able to get information on what trials the patient may be eligible for."

The pilot study involved 60 consecutive new patients at gastrointestinal (GI) oncology subspecialty clinics. The 11 oncologists completed a survey after each visit to assess the usability and impact of the TP program.

"First of all, it works, and the accuracy was very high," Dr. Meropol reported. "Second, the physicians found that it was useful to them."

Of 15 relevant GI-related phase 1 clinical trials, TP identified a mean of 7 eligible trials for each patient. Clinical trials were considered by the treating oncologist for 67% of the patients, and 95% of the physicians reviewed the TP output at the point of care. For 70% of the oncologists, the time spent evaluating eligibility was less than 5 minutes.

A TP report was reviewed for 73% of the patients considered for clinical trials, and the program saved the oncologists time by identifying potential trials during 57% of the visits.

The TP matching algorithm was 100% accurate, and 91% of the oncologists recommended TP for clinical trial screening.

This is just the first version of the tool, Dr. Meropol explained, so there is room to increase the sophistication of TP. "But as a first step and a proof of principle, we really feel that this can save physicians a lot of time in the office and increase accrual in clinical trials."

Funding for the PRE-ACT study was provided by the National Cancer Institute (NCI) to the Case Western Reserve University School of Medicine. Funding for the TP study was provided by the Clinical and Translational Science Collaborative of Cleveland at Case Western Reserve University.

2013 Annual Meeting of the American Society of Clinical Oncology. Abstracts 6500 and 6538. Presented June 3, 2013.

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