Video Intervention Helps Prepare Patients to Participate in Cancer Clinical Trials

January 28, 2016, by NCI Staff

Educating patients with cancer about clinical trials prior to their first visit with their oncologist can improve their ability to make decisions about whether to enroll in a trial, according to a new study.

Patients in the study who took part in a tailored, video-based educational program had a better understanding of clinical trials and fewer concerns about issues such as randomization and side effects than patients who received text-based educational materials, the study authors reported. Overall, however, regardless of the type of educational material patients received, eventual enrollment in a clinical trial was much higher among patients in the study than is typically seen in clinical practice.

The study findings were reported December 23, 2015, in the Journal of Clinical Oncology.

Currently, it’s estimated that fewer than 5 percent of adults with cancer enroll in a clinical treatment trial. Two key barriers that can prevent patients from taking part in clinical trials are knowledge gaps and “negative attitudes,” explained lead investigator Neal J. Meropol, M.D., of the Case Comprehensive Cancer Center in Cleveland, Ohio. Knowledge gaps can range from not understanding what a clinical trial is to not knowing the requirements for informed consent. Negative attitudes encompass a variety of issues, including concerns about randomization, side effects, quality of care, and placebos.

To address these obstacles, the researchers integrated two well-defined decision-making frameworks—the Ottawa Decision Support Framework and Cognitive-Social Health Information Processing Framework—to develop an online, video-based educational program to prepare cancer patients for making decisions about whether to participate in clinical trials. The underlying premise is that preparation for decision making is a key component of making a good decision, which is ultimately based on an individual’s preferences and goals, the researchers explained.

To test the effectiveness of the educational program, called Preparatory Education About Clinical Trials (PRE-ACT), the researchers conducted a randomized clinical trial involving 1,255 cancer patients before their first visit to an oncologist. The patients were randomly assigned to participate in the video-based educational program (PRE-ACT group) or to receive text-only general education materials about clinical trials that were developed by NCI (control group).

Before their initial oncologist visit, patients in the study completed a survey to assess their knowledge and attitudes about clinical trials, as well as their goals and values. For example, they were asked whether quality of life or length of life was more important to them and about their preferences regarding shared decision-making around treatment (e.g., “Do you want the doctor to make the decision for you, or do you want to share in that decision?”).

Based on the responses to this baseline survey, the researchers delivered targeted, 30- to 90-second video clips for patients in the PRE-ACT group to address their specific concerns and knowledge gaps about clinical trials. The videos were carefully scripted with the input of patient advocacy groups and experts in cancer communication.

Patients in both trial groups had improved knowledge and more positive attitudes about clinical trials, and were better prepared to make decisions about participating in clinical trials, the researchers found. PRE-ACT was better than the written materials in improving knowledge and attitudes about trials.

In terms of clinical trial accrual, 21 percent of patients in each trial group enrolled in a clinical trial within 6 months of reviewing the educational materials, which is remarkably high, according to Dr. Meropol.

“These results raise the possibility that preparatory education before the oncologist visit can enhance accrual to clinical trials,” he said.

“The PRE-ACT study is a marvelous example of how tailored interventions, based on an individual patient’s psychosocial barriers to enrolling in clinical trials, can be very effective in overcoming those barriers,” said Kim Witherspoon, of NCI’s Division of Cancer Treatment and Diagnosis. “What I like most about this study was the researchers’ willingness to test their materials in focus groups of patient advocates and cancer patients when they developed their video intervention. Input from these groups was critical, as they are the voices of the target population and provide important insight that may not be generally known.”

An unexpected finding, Dr. Meropol added, was that the video to address concerns about costs of clinical trial participation actually increased patients’ levels of concern.

“We believe that that is because the information given did not guarantee that the costs would be covered by insurance,” said Dr. Meropol. “We gave factual information to patients about the current state of payment for clinical trials at the time, and that was not reassuring at all.”

However, under the Affordable Care Act (ACA), insurance companies are now required to pay for the routine clinical costs for patients taking part in clinical trials. The researchers have since revised the language in the video to reflect the protections included in the ACA.

PRE-ACT, which was developed with NCI support, is freely available on the American Society for Clinical Oncology website. The researchers are now developing an educational program for cancer nurses to increase their ability to discuss clinical trials with patients.

“Because nurses are the most trusted health care professional and spend far more time with patients than doctors do, empowering the nursing workforce to discuss clinical trial opportunities with patients might enhance their participation rates,” explained Dr. Meropol.