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September 13th, 2016

What is stopping patients from enrolling in clinical trials?

By meghanknoedler

ovarian-cancerClinical trials are the mechanism through which new and promising therapies for safe, effective cancer treatment ultimately become available.  Not only do trials help identify new or best-practice therapeutic treatment options, but the act of participating in a trial has been shown to actually improve survival.

One of the most promising areas of research to fight cancer involves immunotherapy -- the use of vaccines or viruses as anti-cancer agents.  Immunotherapeutic approaches through the use of vaccines, stimulates the body’s own cells to identify and fight cancer cells, utilizing a similar mechanism of action as we do with common childhood vaccines including measles, mumps and rubella (MMR). Viral therapies introduce a virus into your body to identify and fight cancer cells. Given their different approaches to attacking cancer cells, the end result remains the same:  to destroy cancer cells.

Participation in trials by patients varies among different cancer types, and so new drugs for a particular cancer come out sporadically, sometimes more, sometimes less.  Some cancer types had as many as 18 new drugs in 2015, whereas ovarian cancer only has had two new drugs approved in the last 20 years. This for the most lethal gynecological cancer – one that results in more than 14,000 deaths per year in the United States alone.

Vaccine and virotherapy is a promising area of potential therapy for a wide range of cancers. Ovarian cancer is one for which these therapies are being researched, yet fewer trials are open in ovarian cancer, thus how we increase adult cancer patient participation in clinical trials remains an important point for further understanding.  How are immunotherapy and virotherapy clinical trials viewed by patients with ovarian cancer? Will patients believe that vaccines and viruses hold cancer fighting potential?

Carmen Radecki Breitkopf, Ph.D., a Mayo Clinic Cancer Center researcher, and her colleagues, wanted to delve deeper. In a collaborative project  including Qualitative Research Services in the Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery and the Department of Medical Oncology; along with the University of Chicago’s Gynecologic Oncology Section; they sought to find out more. They recently published their findings on “Ovarian cancer patients’ and their family members’ perspectives on novel vaccine and virotherapy trials.”

Carmen Radecki-Breitkopf, Ph.D., Associate Professor of Health Services Research and lead author of the study.

The research team found that “more participants were aware of vaccine trials than virus trials, although more than half had heard of at least one of them. Initial reactions to vaccine trials were generally favorable.”

However, they also learned that “for many, childhood experience with vaccines lent a familiar frame of reference. Virus trials elicited more negative initial reactions, including the use of adjectives such as ‘scary’ and ‘dreadful.’ Viruses seemed contagious or difficult to control.”

As patients approached a time in their cancer journey where fewer therapeutic options were available, or they experienced a recurrence, the team found that they were more willing to consider these types of trials.

Thus the study team concluded, “Although vaccine and viral trials are both immunologically-based therapeutic approaches, patients who are offered these trials may perceive their potential benefit and safety quite differently. There is a need to consider terminology, solicit and address ‘gut reactions,’ and provide information that enables patients and their family members to better understand the science behind these trials.”

This was the first study to look at  “gut reactions” to using vaccines and viruses to treat cancer. The team’s findings can help cancer care providers better understand the hope, fear and doubt that exist, and pave the way for future conversations. Understanding patients’ and their family members’ perspectives on the use of  vaccines and viruses as therapy can help identify areas in which enhanced education or information sharing could increase participation in clinical trials.

Read more about clinical trial research at Mayo Clinic.

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Tags: About, Cancer Research, Carmen Radecki-Breitkopf, Center for the Science of Health Care Delivery, clinical trials, CSHCD, Findings, immunotherapy, Kern Center, Opportunities, ovarian cancer, virotherapy

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