Fewer than 2% of US cancer patients choose to participate in oncology trials. Increasing recruitment by just 2 to 3 percentage points could allow investigators to complete a typical study in two, instead of three, years.

A new US initiative aims to develop novel approaches to improving trial recruitment by bringing together expertise in medicine and communication science.

Weill Cornell Medical College, New York City, and Cornell University College of Agriculture and Life Sciences in Ithaca, NY are collaborating on the IMPACT (Improving Methods for Patient Accrual to Clinical Trials) study, which they say addresses recruitment shortages from a fresh angle.

"Hundreds of studies have sought to identify and overcome barriers to enrolment. This project is the first to assess the problem from a socio-psychological perspective, using the specialised methods of risk communication," commented Dr Katherine McComas, principal leader of the IMPACT study and assistant professor in the Department of Communication at Cornell.

"We will be using two proven approaches - the model of Risk Information Seeking and Processing (RISP) and Theory of Planned Behaviour. These will allow us to examine specific factors that influence how patients inform themselves about a clinical trial and decide whether to participate."

Enrolment barriers

Previous research has identified several barriers to enrolment, including fears of randomisation and risk of side-effects; distrust of physicians and researchers; time and other logistical concerns; and lack of familiarity with clinical trials.

Patients may participate in clinical trials because they see potential for better treatment - or any treatment where there is no good alternative - and reduced treatment costs, as well as out of simple altruism. Against this background, RISP explores the inter-relationship between how people seek and interpret information, their beliefs and attitudes, and their actual behaviour.

According to the Theory of Planned Behaviour, a person’s intention to perform a particular behaviour depends on their attitude towards the behaviour, their perception of related social pressures, and how easy it is to perform. They then translate this intention into actual behaviour.

The Leukemia & Lymphoma Society helped finance IMPACT’s first phase, which includes a national survey on attitudes towards participation in clinical trials. "Cancer clinical trials have brought enormous advances in the areas of cancer prevention, treatment and diagnosis. By encouraging broader and more rapid enrolment, the benefits of clinical research, including prevention and treatment, will be more quickly available to a greater number of patients," said Dwayne Howell, the society’s president.

"Our aim is to provide data-supported recommendations for strategies to improve the accrual of patients in clinical trials," added Dr Andrew Dannenberg, co-leader of IMPACT and professor of medicine at Weill Cornell Medical College.

"Future phases of the study will develop specific tools to better inform patients, educate them as to the pros and cons of enrolling in clinical trials, as well as create strategies to facilitate participation so that new therapies for many disorders can be more rapidly designed and evaluated in order to deliver their maximal benefit."