Why Are Cancer Patients Not Enrolling in Clinical Trials?

Veronica Hackethal, MD

January 07, 2016

Participation in cancer clinical trials is low. Educational videos specifically tailored to individual cancer patients may help them decide about whether or not to participate in clinical trials, but financial worries may be the biggest barrier to participation, according to two related studies published online December 23, 2015, in the Journal of Clinical Oncology.

The first study represents the largest randomized controlled trial so far to look at an intervention designed to address barriers to clinical trial entry among cancer patients.

"We found that educational videos, tailored to individual knowledge gaps and attitudes, can help cancer patients be better prepared to consider clinical trials as a treatment option," commented first author Neal Meropol, MD, professor of cancer research and therapeutics at Case Western Reserve University, in Cleveland, Ohio.

Although clinical trials are critical for finding new cancer cures, few patients participate in them, he said. Past research by this team has suggested that inadequate knowledge and negative attitudes about clinical trials could represent barriers to participation, Dr Meropol explained.

"A new cancer diagnosis can be overwhelming. So much information is thrown at patients in the first encounter with an oncologist," he continued. "This deluge of information can be tough to digest, especially since the stakes are so high."

In the study, researchers used a program called PRE-ACT (Preparatory Education About Clinical Trials). The webbased educational tool was designed to lead patients to consider enrolling in a clinical trial, if appropriate for their individual case, before their first consultation with an oncologist and to help them make a "good personal decision," according to Dr Meropol. PRE-ACT uses videos tailored to patients' individual needs and knowledge, as determined on the basis of their responses to a baseline questionnaire. It has three main components: clinical trials knowledge and attitudinal barriers, values assessment with patient clarification, and a video library.

The phase 3 trial to test the videos was conducted in adult cancer patients recruited between April 2010 and September 2012 at four National Cancer Institute (NCI) centers in Ohio, Pennsylvania, Illinois, and Michigan. Participants completed a baseline online questionnaire at the beginning of the study. Researchers then randomly assigned participants to PRE-ACT (n = 623) or control (general information on clinical trials that was provided by the NCI) (n = 632).

Results showed that after the interventions, both PRE-ACT and control groups had better knowledge and attitudes than when they started the trial (P < .001).

The PRE-ACT group, however, did better than the group receiving NCI information with respect to improvement of knowledge (P < .001) and a decrease in attitudinal barriers (P < .001). Also, in the PRE-ACT group, there was a trend toward improved preparedness (P < .09).

In addition, patients expressed greater satisfaction with PRE-ACT than with NCI text.

However, there was no difference between the two groups with respect to the percentage of patients (26%) who enrolled in clinical trials during the 6 months following study.

Patients needed high-speed Internet access or had to be willing to fill out the study questionnaires in the clinic, which could limit the generalizabilty of the study.

"Patient education is only one piece of the puzzle that we need to address in order to improve participation in clinical trials," Dr Meropol concluded. "We are now developing a video-based tailored educational program about clinical trials for cancer nurses, as nurses spend more time with patients than anyone else on the healthcare team."

The most commonly expressed concern among patients in this study related to financial issues. A secondary analysis of data, which was reported in a separate article, looked at whether or not "financial toxicity" negatively affects the decision to participate in clinical trials.

"Our study showed that financial concerns may make it difficult for patients to make high-quality decisions regarding their care by decreasing their self-efficacy and preparation and increasing their distress and decisional conflict," commented first author Yu-Ning Wong, MD, of the Fox Chase Cancer Center, Temple University Health System, Philadelphia, Pennsylvania.

The analysis focused on three questions about financial issues that were included in the baseline questionnaire. It also looked at questions about self-efficacy, preparation for decision making, subjective distress, and decisional conflict.

Results showed that 22% of patients believed cost of care to be a "major" or "extreme" burden. Nearly 40% worried that their insurance would not cover the cost of a clinical trial, and 30% worried that they could not afford the cost of a clinical trial.

Patients with lower self-efficacy (P = .004), lower preparation for decision making (P < .001), and greater decisional conflict (P < .001) and distress (P < .001) had more financial concerns. This remained true after adjusting for age, race, sex, education, employment, and hospital location (P < .001 for all).

The findings were not limited to patients with metastatic disease or specific tumor type, suggesting that these concerns apply to patients across the disease spectrum.

"Healthcare institutions and insurers should help to provide more transparent information regarding expected out-of-pocket costs for testing, treatment, and procedures," Dr Wong stressed. "In many cases, it can be very difficult for patients to anticipate what their bills will be... [because] they receive them weeks if not months after the visit, test, or procedure."

Providers and insurers should provide financial counseling so that patients can understand their coverage and financial obligations, Dr Wong believes.

"Uncertainty can be very stressful for patients, and fears about whether their insurance will cover the service or whether they can afford the copayments are at the forefront of many patients' minds," she highlighted. "This lack of up-front information may make it difficult for patients to budget appropriately."

The Institute of Medicine has stated that healthcare organizations should make health plan and health insurance products more transparent, according to Dr Wong. In addition, the Affordable Care Act mandates that commercial insurance cover routine costs of clinical trials.

PRE-ACT is available at www.cancer.net/preact.

Several authors have reported relevant financial relationships, which are listed in the original articles.

J Clin Oncol. Published online December 23, 2105. Study 1 abstract, Study 2 abstract

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