Director, Clinical Trial Support Center The Leukemia & Lymphoma Society Foxboro, Massachusetts, United States
Background: Clinical trials are key to advancing cancer treatment, yet participation rates in the U.S. remain low at an estimated 6.3% across the US (Unger et al., 2021). Many barriers to clinical trial participation exist and identifying appropriate clinical trials can be overwhelming for patients, and resource intensive for healthcare providers. Barriers may include institutional and provider related barriers, barriers related to trial design, and patient related barriers (Sae-Hau et al., 2021).
Intervention: The Leukemia & Lymphoma Society developed the Clinical Trial Support Center (CTSC), a free clinical trial nurse navigation service for blood cancer patients, their families and healthcare providers. The CTSC is a team of 9 nurse navigators, with expertise in pediatric and adult hematology/oncology, who work one-on-one with patients, their caregivers or healthcare providers. A dedicated nurse navigator completes comprehensive nursing, educational and psychosocial assessments to understand a patient’s diagnosis and treatment history, their understanding of available treatment options and clinical trials, goals of care and supports available to participate in a clinical trial. Taking this information into consideration, the nurse navigator completes an unbiased search, providing an individualized list of potential clinicals trials and educational resources. The nurse navigator may also contact principal investigators, study coordinators and sponsors to inquire about a patient’s eligibility, referral process and waitlist, travel assistance and other financial resources. The goal of the CTSC is not for every patient to enroll into a clinical trial, but to increase awareness of clinical trials as a treatment option, facilitate informed and shared decision-making between the patient and their healthcare time and to minimize the barriers to enrollment if a patient decides that a clinical trial is right for them.
Findings: During July 1 2021 and June 30 2022, the CTSC nurse navigators assisted 751 new blood cancer patients with diverse diagnoses and disease states; at presentation, 47%, had relapsed/refractory disease. Of patients who were eligible for a clinical trial search, 19% (n=70) enrolled into a clinical trial. On behalf of the patients who enrolled on a clinical trial, the average number of phone and email interactions by a CTSC nurse navigator on behalf of a patient (e.g., to patient/family member, healthcare provider or clinical trial research staff) was 23.96 per patient, compared to 14.82 per patient for those who did not enroll after receiving a search (n=298). Reasons patients did not enroll in a clinical trial with assistance from the CTSC will be presented in table format but include patient chose standard of care, inclusion/exclusion criterion, patient condition deteriorated rapidly or passed away, no trials within local geography/lack of social support and insurance/financial constraints.
Discussion: The Leukemia & Lymphoma Society’s Clinical Trial Support Center is a free nurse navigation service for blood cancer patients, their caregivers, and healthcare providers. The unique relationship between a patient and their nurse navigator plays a pivotal role in overcoming many barriers to clinical trial enrollment. Nurse navigation is also able to offload the time-consuming work of identifying potential trials and clinical trial outreach for healthcare providers.
