Background: Low enrollment rates for cancer clinical trials have been an ongoing barrier to scientific advances in oncology care. Average clinical trial participation rates are estimated to be as low as 8% nationally, with great variability based on demographics.1 Whereas studies have explored the benefit of patient navigation in improving trial enrollment and completion at an institutional and statewide level,2,3 the impact of an advanced practice clinical trial nurse navigation program on trial enrollment from a national vantage point has not yet been discussed in the literature. With more than 178,520 new cases of leukemia, lymphoma, and myeloma anticipated to be diagnosed in 2020, clinical trial participation in studies investigating new treatments for hematologic malignancies are more important than ever.4
Objective: To determine the impact of the Leukemia & Lymphoma Society (LLS) Clinical Trial Support Center (CTSC) nurse navigation services on clinical trial enrollment for adult and pediatric patients with hematologic malignancies and the perceived helpfulness of the service.
Methods: LLS created the CTSC in 2016 and expanded the advanced practice nursing (APN) staff in 2019. The CTSC is charged with providing a personalized, patient-centered navigation service to identify and connect patients with potential clinical trials while addressing barriers to enrollment and educating patients about clinical trials. The APN staff assesses the patient’s preferences, physical condition, medical history, insurance coverage, ability to travel, and financial barriers to provide an individualized list of appropriate clinical trials.
A retrospective online survey of 474 patients and caregivers who utilized the CTSC from May 2018 to April 2019 was conducted by RTI International on behalf of LLS from July 2019 to August 2019 utilizing a standardized tool.
Results: A 30% response rate for the online survey provided 142 partially or fully completed surveys. A majority of respondents were white (92%, n = 114/124) and reported having at least a 4-year college degree (71%, n = 89/126). Of patients and caregivers surveyed, 29.8% (n = 39/131) enrolled in a clinical trial after receiving assistance from the CTSC APN. Over half of the participants who enrolled in a trial noted the CTSC nurse navigator helped them find the trial in which they enrolled (55.9%, n = 19/34). Further, 99.2% (n = 130/131) of respondents found the conversation(s) with the CTSC nurse navigator to be helpful, and 98.5% (n = 128/130) reported the CTSC nurse navigator’s ability to answer questions as great or excellent.
Conclusion: Use of a nationally focused, advanced practice clinical trial nurse navigation program for hematologic malignancies facilitated clinical trial enrollment of 21%, well above the national estimate of trial participation of 8%. The vast majority of those who utilized the service found it helpful. Similar to noted disparities in nationwide clinical trial participation, there is lack of diversity among those historically served by the CTSC. LLS is actively working to improve the reach of this service into racially, ethnically, and socioeconomically diverse communities.
- American Cancer Society. Cancer Action Network. Barriers to Patient Enrollment in Therapeutic Clinical Trials for Cancer - A Landscape Report. www.fightcancer.org/policy-resources/clinical-trial-barriers. 2018.
- Ghebre RG, Jones LA, Wenzel JA, et al. State-of-the-science of patient navigation as a strategy for enhancing minority clinical trial accrual. Cancer. 2014;120:1122-1130.
- Moffitt K, Brogan F, Brown C, et al. Statewide cancer clinical trial navigation service. J Oncol Pract. 2010;6:127-132.
- American Cancer Society. Cancer Facts & Figures 2020. www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2020/cancer-facts-and-figures-2020.pdf. 2020.