The Leukemia & Lymphoma Society Nurse Navigators Help Patients Overcome Barriers to and Enroll in Blood Cancer Clinical Trials
Analysis of the LLS model supports the potential that it can be replicated to increase patient access to clinical trials across all cancer types
Rye Brook, N.Y. (July 29, 2021) – Specially trained nurse navigators can help patients with a blood cancer find appropriate clinical trials and overcome barriers to participating in them, according to an analysis of patients and caregivers who used The Leukemia & Lymphoma Society’s (LLS) Clinical Trials Support Center (CTSC) over a two-year period. The findings were published in the June 6 issue of JCO Oncology Practice.
The study authors say that while the CTSC nurses can help overcome barriers for many patients, their analysis demonstrates the need to increase opportunities for clinical trial enrollment earlier in the cancer care continuum and among patients with Medicaid. The success of their approach suggests a potential benefit of replicating this unique service model among other cancer types.
The CTSC is a free, national, telephone-based service with nurse navigators supporting patients and caregivers every step of the way. The CTSC process starts with a comprehensive nursing and psychosocial assessment to begin an individualized clinical trial search. The goal of the CTSC’s personalized service is to increase patient awareness of clinical trial opportunities, facilitate shared decision-making between patients and their oncologists, and minimize barriers to enrollment for those who feel a clinical trial is right for them.
The authors analyzed data from 750 patients served by the CTSC between October 2017 and October 2019 (patients from outside the U.S. and those whose cases were still open at the end of the study period were excluded from the analysis). Across the entire population of 750 patients or loved ones who inquired, one in six (16.1%) patients enrolled in a clinical trial. Among the 537 patients or loved ones who had a personalized clinical trial search and for whom the enrollment outcome is known, one in five (22.5%) patients enrolled in a clinical trial.
The nurses had an average of 25 interactions for each patient who enrolled in a clinical trial and 16 interactions for those who did not. These interactions may include calls or emails with the patients, their caregivers and healthcare providers, and clinical trial sites. The number of interactions needed in both cases is a good illustration of the challenges and amount of work patients and their healthcare providers may face to find, learn about and enroll in clinical trials.
Among those who contact the CTSC, the rate of trial enrollment is not significantly different between patients who have not yet received any treatment and those who have relapsed, but the CTSC receives four times more requests for assistance from the latter group. This demonstrates that clinical trials may not be discussed as a potential treatment option until a patient has exhausted other options.
“Clinical trials are not just an option for those whose cancer is progressing despite earlier treatment; they can also give newly diagnosed patients access to state-of-the art therapies,” said author Leah Szumita, MS, RN, CCRN, ACNS-BC, director of the CTSC.
Low patient participation rates cause approximately 20% of U.S. cancer trials to fail.1 “Increasing access to clinical trials can help today’s patients, and it also helps us gain the best information from cancer research to better help tomorrow’s, as well,” said study co-author, Maria Sae-Hau, PhD, who leads development, implementation, and evaluation of patient access and educational initiatives at LLS. LLS is also working to increase access to trials among underrepresented groups, patients from rural areas, young adults and the elderly.
People with Medicaid who were served by the CTSC were 95% less likely to enroll into a clinical trial than those with private or commercial insurance. The reasons for this are complex, but presently Medicaid is not required to cover the cost of routine care within clinical trials, and clinical trial coverage itself varies by state.
“Survival rates for some blood cancers have doubled, tripled, and even quadrupled in recent decades, and today’s clinical trials are testing incredibly innovative new therapies,” said Szumita. “Every cancer patient should have equal access to information to make an informed decision about whether a clinical trial is right for them.”
To learn more about The Leukemia & Lymphoma Society’s Clinical Trial Support Center, click here.
1Stensland KD, McBride RB, Latif A, et al (2014). Adult cancer clinical trials that fail to complete: an epidemic? J Natl Cancer Inst, 106(9):doi: 10.1093/jnci/dju229