University Hospitals Case Medical Center Experts Present Data Addressing Patient and Physician Barriers to Clinical Trials

Chicago, IL—Researchers from University Hospitals Case Medical Center (UHCMC)’s Seidman Can­cer Center presented findings from 2 studies evaluating new technologies designed to address common barriers to patient enrollment in clinical trials at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

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 to 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% of cancer patients participate in them,” said 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 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 UHCMC Seidman Cancer Center are designed to break down those obstacles by providing individualized education for patients and new technology to help oncologists to 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 alone, there are currently more than 300 ongoing clinical trials focused on cancer.

About the Studies
Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials (Abstract 6500)

Dr Meropol presented the 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 1255 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- to 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 was not tailored to their individual barriers. A follow-up survey was conducted to reassess patient knowledge and attitudes.

The results showed that PRE-ACT significantly improved patient understanding and attitudes toward 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 with patients who received written information.

Trial Prospector: An Automated Clinical Trials Eligibility Matching Program (Abstract 6538)

Co-authors Andrew Parchman, MD, Hematology and Oncology Fellow at UHCMC, and Dr Meropol presented 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 (EMRs).

Patients Unwilling to Let Costs Influence Their Treatment
The issue of cost in clinical decision-making is increasingly becoming necessary in the face of growing healthcare costs, limited resources, and often limited access to care. Involving patients in the cost discussion has been suggested as a way to begin to curb the rising costs of care. A new study investigated the inclination of Americans with health insurance to discuss their willingness to have cost as part of the decision-making in their care (Sommers R, et al. Health Aff [Millwood]. 2013;32:338-346).

The study population included 22 focus groups of Americans with health insurance from 2 geographically distinct metropolitan areas—Santa Monica, CA, and Washington, DC. Although all of the participants had insurance, they varied by age, race, education, and income levels. At least 50% had incomes <300% of the federal poverty level and 43% had incomes <$40,000.

“We found that the majority of participants were unwilling to consider cost when deciding between nearly comparable options and generally resisted the less expensive, marginally inferior option,” the authors wrote.

The 4 barriers to participants’ willingness to consider cost in treatment decisions included:

  • Preference for the best therapeutic option, regardless of cost
  • Inexperience in making trade-off decisions between health and money
  • Lack of concern for money spent by society and health insurance
  • No sense of personal responsibility for the cost of care
  • Noncooperation because of prioritizing self-interest concerns.

Overall, participants wanted the best care and were not interested in considering limited resources and making trade-offs between their health and money, holding physicians responsible to provide them with the best care available, regardless of cost.

Based on their findings, the investigators concluded that “for cost to be an explicitly recognized and discussed factor in clinical decisions, public attitudes about healthcare costs must first undergo a significant shift.”

Patients with Cancer at Risk for Bankruptcy
Being diagnosed with cancer in­­creases a person’s risk for bankruptcy, according to results of a new study analyzing data from the National Cancer Institute (NCI)’s SEER (Surveillance, Epidemiology and End Results) program (Ramsey S, et al. Health Aff. May 15, 2013 [E-pub ahead of print]).

A team of researchers led by Scott Ramsey, MD, PhD, Health Economist at Fred Hutchinson Cancer Research Center (FHCRC) and Director of the Hutchinson Institute for Cancer Outcomes, analyzed data from the Cancer Surveillance System of Western Washington, a population- based cancer registry at FHCRC, which is NCI’s SEER program. The team compared the data of patients with cancer with people without cancer and matched them with bankruptcy records for those populations between 1995 and 2009.

The results showed “strong evidence of a link between cancer diagnosis and increased risk of bankruptcy,” the investigators wrote. “Our study thus raises important questions about the factors underlying the relationship between cancer and financial hardship.”

During the study period, 197,840 people in Western Washington were diagnosed with cancer and met the inclusion criteria for this study. These patients were matched for age, sex, and zip code with a control group of people without cancer. Of the patients with cancer, 4408 (2.2%) filed for bankruptcy protection after diagnosis compared with 2291 (1.1%) of the matched controls who filed for bankruptcy during the same period.

“This is the strongest evidence we have between a disease and risk for severe financial distress,” said Dr Ramsey. “I’ve not seen other studies that linked databases of this quality.”

Generic Name Linked to Medication Errors
The US Food and Drug Admin­istration (FDA) has warned healthcare professionals about potential medication errors resulting from confusion with the nonproprietary name for the recently approved breast cancer drug ado-trastuzumab emtansine (Kadcyla; also known as T-DM1).

The FDA noted that in various online publications and in different medical electronic systems the drug is sometimes referred to incorrectly as trastuzumab, which is the active ingredient in the older breast cancer drug Herceptin, which had a different dosing and a different treatment schedule.

The FDA-approved nonproprietary name for Kadcyla is “ado-trastuzumab emtansine” but the prefix “ado-” is often dropped, which may lead to the confusion with trastuzumab (ie, Herceptin). The FDA notes that it is, therefore, important to keep the prefix with the nonproprietary name when referring to Kadcyla, when prescribing the medication, and in electronic medical records (EMRs) or any online or other publications. The FDA noted that some third-party publications, compendia references, health information systems (ie, EMR systems and other systems used for pharmacy prescription processing, wholesaler ordering, and pharmacy ordering), and various websites are incorrectly using “trastuzumab emtansine” and omitting the “ado-” prefix.

Although no medication errors related to confusion between Kadcyla and Herceptin have been reported since the approval of Kadcyla on February 22, 2013, such errors did occur during the clinical trials that evaluated the safety and efficacy of the drug before its approval, according to the FDA. The agency advises health plans, pharmacists, and prescribers to implement strategies to warn against and look for any confusion between the 2 drugs in electronic systems, and, when needed, to correct the error.

Furthermore, the FDA insists that ado-trastuzumab emtansine should not be substituted for or used with trastuzumab. The recommended dose of Kadcyla is 3.6 mg/kg, administered by intravenous infusion every 3 weeks for a total of 21 days. This drug should not be prescribed at higher doses. By contrast, the recommended dose of Herceptin is significantly higher, up to 8 mg/kg per loading dose, followed by a maintenance dose of 6 mg/kg every
3 weeks. These drugs may not be used concomitantly. (May 6, 2013)

FDA Puts High Priority on Social Media Guidance for Drugs and Devices
One of the FDA’s highest priorities at the moment is providing guidance on drugs and medical devices to drug and device companies on their use of social media, according to Tom Abrams, head of the FDA’s Office of Prescription Drug Promotion.

The FDA hopes to meet its designated deadline of July 2014 for issuing that guidance. In the interim, the FDA had a virtual conference on May 30 to advise drug- and device-makers on how to take advantage of social media, including Facebook, Twitter, and YouTube, for disseminating their news and breakthroughs via online marketing within the FDA regulatory limits.

The virtual conference spelled out what companies can and cannot do regarding the marketing of their drugs and devices in social media—the latest channel for influencing policymakers, patients, payers, and healthcare providers. (May 14, 2013.)

Participation in ASCO’s Quality Practice Program Improves Performance Scores
Oncology practices that partici­pate in the American Society of Clin­­ical Oncology (ASCO)’s Quality Oncology Practice Initiative (QOPI)—a program of self-reported metrics on performance measures—demonstrate improved performance scores on several measures, including:

  • Providing adjuvant chemotherapy (which has shown to improve survival) for breast, colorectal, and non–small-cell lung cancers: ?90% of participating practices perform as recommended
  • Improved uptake of new clinical practice (following new guidelines or clinical evidence): from 5% to 69% in the past 4 years.

“This study further shows that participation in quality assessment programs like QOPI should provide reassurance to people living with cancer that they are receiving high-quality care,” said Sandra M. Swain, MD, FACP, ASCO President. “Nearly 600 practices in the United States are already participating in QOPI, in part because it provides a systematic process, a library of diverse quality measures, a collection tool, and reliable information to assess the care they provide. QOPI is also the gateway to QOPI Certification, which recognizes practices that demonstrate performance on designated QOPI measures and meet certification standards for quality and safe care.” (ASCO in Action; March 12, 2013.)

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