It may become easier for cancer patients to understand and feel comfortable enrolling in cancer clinical trials thanks to a newly created Internet-based multimedia informed consent tool, according to a recent study. The resource has the potential to increase the low percentage of adult cancer patients who participate in clinical trials (2%-4% nationwide), says the research group from the Perelman School of Medicine at the University of Pennsylvania who conducted the survey.
“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 Internet-based multimedia informed consent resource developed by Penn researchers contained a video of a trial principal investigator talking through the traditional informed consent process. A PDF of the written informed consent was also included. The video may be stopped, started, and replayed as many times as the patient deems necessary. Family members or other support people who are not present for the appointment in which the information is initially discussed may also view the video. The video module may be especially beneficial for patients who speak English as a second language or for those with literacy issues. Furthermore, patients are able to take their time understanding the trial’s protocol, potential risks and benefits, and other important information with the additional PDF of the written materials provided.
The health professionals surveyed regarding their experiences with the new tool included research coordinators, research nurses, radiation oncologists, and others. Among the 23 participants in the study:
- 94% were pleased with the information in the online resource
- 88% believe it will “greatly enhance” the informed consent process for the patient
- 75% felt the online tool would expedite the informed consent process
- 75% said they would like to acquire similar multimedia content for their future trials
After a pilot program with healthcare professionals, the multimedia informed consent tool was added to the standard informed consent process for patients receiving treatment at Penn’s Roberts Proton Therapy Center. Researchers plan to further study the its benefits through patient satisfaction surveys and the evaluation of its influence on patient participation in clinical trials.
Source: Perelman School of Medicine.