• October 3, 2011
  • Penn-Developed Online Informed Consent Tool Could Boost Number of Patients in Cancer Clinical Trials

MIAMI – A new multimedia informed consent tool accessed via the Internet may make it easier for cancer patients to understand and feel comfortable enrolling in clinical trials, according a study conducted by researchers in the Perelman School of Medicine at the University of Pennsylvania that will be presented at the American Society for Radiation Oncology’s (ASTRO) 53rd Annual Meeting. The research group points to the tool as a potential way to buoy the low percentage of adult cancer patients who participate in clinical trials, which hovers between 2 and 4 percent nationwide.

"We know that the informed consent process can be confusing and tedious for cancer patients, who are asked to read many documents and understand a tremendous amount of information in a short amount of time – often when they are already frightened, tired, and vulnerable due to their illness," said senior author James Metz, MD, an associate professor and vice chair of the clinical division in Penn Medicine’s department of Radiation Oncology. "We believe our tool can make that process easier for patients and their families, as well as for clinicians, who often struggle to accrue enough patients to complete trials."

The Penn researchers developed an Internet-based multimedia informed consent resource (housed on Penn Medicine's cancer web site, OncoLink, www.oncolink.org) which contained a video version of a trial principle investigator talking through the traditional informed consent process for proton therapy clinical trials, as well as a PDF of the written informed consent. The tool allows patients to stop, start, and replay the video as many times as they would like, as well as to play it for family members or other support people who may not be able to be present for the appointment in which the information is initially discussed. This video component may be especially helpful for patients with literacy issues, or to those who speak English only as a second language. Providing a PDF of the written materials also allows patients to take their time understanding the protocol, its potential risks and benefits, and other important information.

Among 23 health professionals -- research coordinators, radiation oncologists, research nurses and others – surveyed about their experiences with the new tool, 94 percent reported they were pleased with the information presented in the online resource. Seventy five percent said they thought the resource would expedite the informed consent process, and 88 percent think it will "greatly enhance" the process for the patient. Seventy five percent of respondents said they would like to have similar multimedia content created for their trials in the future.

Proton therapy research, in particular, represents an opportunity to improve the informed consent process, since the modality is new and therefore many not be well understood by the public at a time when doctors are increasingly studying its use. After piloting the multimedia informed consent tool with health professionals, the research team put it into practice as an adjunct to the standard informed consent process for patients receiving treatment at Penn’s Roberts Proton Therapy Center. They plan to further study the tool’s utility via patient satisfaction surveys and evaluation of impact on patient accrual for clinical trials.

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Penn Medicine is one of the world's leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $4.3 billion enterprise.

The Perelman School of Medicine has been ranked among the top five medical schools in the United States for the past 17 years, according to U.S. News & World Report's survey of research-oriented medical schools. The School is consistently among the nation's top recipients of funding from the National Institutes of Health, with $392 million awarded in the 2013 fiscal year.

The University of Pennsylvania Health System's patient care facilities include: The Hospital of the University of Pennsylvania -- recognized as one of the nation's top "Honor Roll" hospitals by U.S. News & World Report; Penn Presbyterian Medical Center; Chester County Hospital; Penn Wissahickon Hospice; and Pennsylvania Hospital -- the nation's first hospital, founded in 1751. Additional affiliated inpatient care facilities and services throughout the Philadelphia region include Chestnut Hill Hospital and Good Shepherd Penn Partners, a partnership between Good Shepherd Rehabilitation Network and Penn Medicine.

Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2013, Penn Medicine provided $814 million to benefit our community.

 

 

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