March 15, 2013 | by Roberta Nichols
Clinical trials can make an enormous difference for individual cancer patients – and for cancer patients overall. But despite an increase in their availability, nationwide, less than 5 percent of women with breast cancer generally enroll in them. City of Hope researchers set out to understand why.
In a study focusing on breast cancer patients treated at City of Hope, the researchers explored the barriers that keep clinical trial participation low and examined ways to boost accrual rates.
“Advances in the treatment of breast cancer are made mostly through interpreting the results of well-designed and carefully conducted clinical trials,” said George Somlo, M.D., professor of breast oncology in the Department of Medical Oncology and Therapeutics Research at City of Hope and senior author of the new study in Applied Nursing Research (published online March 13).
Despite recommendations by the National Comprehensive Cancer Network, only a minority of patients treated in academic centers and community practices enroll in clinical trials. Somlo and his research team set out to investigate what percentage of City of Hope breast cancer patients participated in treatment trials over a one-year period, and the reasons for the lack of accrual.
Data for the study were obtained from medical records of patients with all stages of breast cancer seen at City of Hope during 2009. The good news is that, here, participation was relatively high.
Of 418 patients evaluated in the study, 163 patients (39 percent) had a suitable trial available to them, and 138 of those met all eligibility criteria for enrollment. However, only 80 women (58 percent of those eligible for trials) elected to participate. Of the remaining 58 patients, 24 percent declined to participate, and 76 percent were not referred to a potentially available trial by their treating physicians.
“Enrollment of eligible breast cancer patients onto therapeutic clinical trials at City of Hope is above average compared to patients treated in the community, overall,” said former City of Hope nurse and the study’s first author, Suzanne Swain-Cabriales, R.N., who now works in the Clinical Research Office at Cedars-Sinai-Samuel Oschin Cancer Center. “However, the proportion of breast cancer patients participating in clinical trials remains low, predominantly due to lack of availability of trial choices that patients and the treating team find both innovative and potentially beneficial.”
Over the years, many reasons have been identified to explain lack of trial enrollment, including mistrust of the health care system, patient bias against clinical trials, poor performance status, other health conditions, insurance and transportation issues, lack of physician time and dedicated research staff, and restrictive eligibility criteria.
In addition to confirming prior findings, this study revealed that patients with more advanced disease – and fewer standard treatment options – were more likely to consider clinical trials compared to those with earlier stages of the disease.
Somlo said he and his colleagues were surprised that in this study, a higher than expected percentage of patients participated in clinical trials, and that there was no obvious correlation with ethnicity and age.
In general, awareness campaigns, clinical trial registries and Web-based search engines have improved patient accruals onto clinical trials, researchers said. They also suggested that nurses – given their unique position of trust among patients – may help recruit new enrollees by demystifying the process. “By knowing the basics of clinical trials, nurses may be able to improve participation rates in clinical trials and advocate for clinical research,” they wrote in the study.
Added Somlo: “It behooves the research team to design and make available our own clinical trials or collaborate with outside investigators to provide our patients with a wide variety of treatment options suitable to their individual needs.”
The study’s findings have broad implications for future research, Somlo said. "We need to increase the number of suitable and exciting trials available for our patients. And, in this health economic climate, it is especially important to make sure that the resources are there and patients are provided access to enroll in innovative, novel, and preferably patient and target-specific protocols.”
Other experts involved in this study included City of Hope’s Joyce C. Niland, Ph.D., the Edward and Estelle Alexander Chair in Information Sciences, and Tracy Stiller, both in the Department of Research Information Services. It also included their former City of Hope colleague Laura Bourdeanu, now with the Department of Nursing at the Sage Colleges in Troy, N.Y.