Patients with chronic lymphocyticleukemia (CLL) typically have innate/adaptive immune system dysregulation, thus the protective effect of coronavirus disease 2019 (COVID-19) vaccination remains uncertain. This prospective review evaluates vaccination response in these patients, including seropositivity rates by CLL treatment status, type of treatment received, and timing of vaccination. Antibody persistence, predictors of poor vaccine response, and severity of COVID-19 infection in vaccinated patients were also analyzed. Practical advice on the clinical management of patients with CLL is provided. Articles reporting COVID-19 vaccination in patients with CLL, published January 1, 2021-May 1, 2022, were included. Patients with CLL displayed the lowest vaccination responses among hematologic malignancies; however, seropositivity increased with each vaccination. One of the most commonly reported independent risk factors for poor vaccine response was active CLL treatment; others included hypogammaglobulinemia and age >65-70 years. Patients who were treatment-naive, off therapy, in remission, or who had a prior COVID-19 infection displayed the greatest responses. Further data are needed on breakthrough infection rates and a heterologous booster approach in patients with hematologic malignancies. Although vaccine response was poor for patients on active therapy regardless of treatment type, CLL management in the context of COVID-19 should aim to avoid delays in antileukemic treatment, especially with the advent of numerous strategies to mitigate risk of severe COVID-19 such as pre-exposure prophylaxis, and highly effective antivirals and monoclonal antibody therapy upon confirmed infection. Patients with CLL should remain vigilant in retaining standard prevention measures such as masks, social distancing, and hand hygiene.

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Background: Little progress has been made in the past decade on improving clinical trial enrollment in the United States, particularly for adults and those in ethnic and racial minorities. Oncology nurses play a pivotal role in identifying and addressing patient concerns about clinical trials. Objectives: The aim was to identify patient-related barriers to clinical trial participation using a mixed-method patient survey and offer insights to develop evidence-based implementation strategies to address these barriers. Methods: A retrospective survey was conducted of patients who were not interested in participating in a clinical trial to quantify the reasons these patients chose not to participate. Directed qualitative content analysis was used to identify themes that emerged from the write-in responses. Findings: The greatest patient-reported barriers were misperceptions about placebos, not wanting to feel like a ‘human guinea pig’, uncertainty surrounding clinical trial treatment effectiveness compared to standard care, and concerns about additional appointments or tests. Oncology nurses can address patient enrollment barriers by providing targeted education and participating in the informed consent process.

e14086 Background: Only about 3% of adult cancer treatment is within a clinical trial (CT). Patient personal factors may impact willingness to participate. We leveraged CTs embedded in Clinical Oncology Pathways (COP) to examine patient barriers to CT participation. Methods: A COP program used in an academic cancer center embeds CTs that are open for accrual at the center. Providers must either select the CT to alert the research team for patient screening for the CT or provide a reason for bypassing the CT before the COP presents standard care options. This study includes patients with solid tumors receiving systemic therapy for whom a CT is presented in the COP and the provider documented that the patient was “not interested in this trial”. Prior to being offered the survey, these patients were asked if they had been interested in participating in a CT and were considered ineligible for the survey if they said “yes”. The survey was comprised of 29 Likert, demographic, multiple choice and open-ended questions. We categorized patients’ reasons for declining to enroll in a CT, and attitudes about CTs. Results: Among 1108 patients with CTs presented to the provider in COPs from May 2018 to June 2019 there were 164 identified by the provider as not interested in a CT. 23 were deceased, and 54 were not able to be contacted. 57 were otherwise ineligible. Of these, 33% did not recall being offered a CT. Of the 30 patients approached, 9 declined and 21 completed the survey (70% participation). Cancer types included gastrointestinal (33%), breast (19%), non-small cell (14%), pancreas (14%) and others (20%). 66% were female and 80% had metastatic cancer. Age ranged from 41 to 69 years (median 66). Race/ethnicity was Caucasian (81%), African American (10%), American Indian/Alaskan Native (5%) and non-specified (5%). When asked, “How do you view being asked to participate in cancer research, 76% saw it as “a positive thing”. Patient primary concerns were desire for more information on study outcomes (42%), concerns about additional appointments or tests (28%) and concerns about receiving a placebo (23%). Conclusions: There is a gap between patients’ positive views of clinical trials and their willingness to participate. This suggests that barriers identified are modifiable. Many who initially decline CTs may be open to joining a clinical trial with further education.Interventions such as the Meropol et al Preparatory Education About Clinical Trials (J Clin Oncol 2015:34:469) should be considered for broad implementation.

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