Background: Accessing chimeric antigen receptor (CAR) T-cell clinical trials for relapsed and refractory B-cell acute lymphoblastic leukemia (ALL) is challenging for pediatric patients who have experienced a relapse of B-cell ALL or have been refractory to standard therapy. The Children’s Hospital of Philadelphia treated the first pediatric patient with B-cell ALL using CAR T-cell therapy in 2012. Since then, over 150 patients have been treated with this novel therapy. The Cancer Immunotherapy Program was developed and currently manages multiple CAR T-cell therapy trials. From the time of program inception, the number of referrals continued to grow, and the need for a nurse navigator was identified to support timely access to care for this patient population. In fiscal year (FY) 2012, our program received 44 domestic referrals. In FY 2017, this number had increased to 125 domestic referrals.
Pediatric patients with relapsed and refractory B-cell ALL are often left with few standard treatment options and may be referred for CAR T-cell therapy.1 Accessing this therapy requires careful care planning and extensive multidisciplinary coordination. To receive CAR T-cell therapy, patients must first undergo T-cell apheresis, and, if eligible to enroll in a trial, their cells are reengineered to target their cancer. This therapy is highly personalized in nature; therefore, production capabilities are limited. Overcoming this challenge requires expert care coordination throughout the often lengthy process. There is a fine balance of obtaining and maintaining disease control, seeking insurance approval for treatment, mitigating socioeconomic and geographic challenges, and maintaining adequate organ function to ensure the patient is able to safely tolerate the potential side effects of CAR T-cell therapy. Successfully enrolling a patient in a CAR T-cell therapy trial requires expert care coordination; patient, family, and care provider education; and thorough case evaluation.
Objective: To create a pediatric nurse navigator role with standard triage and communication practices to facilitate efficient care planning for patients with relapsed and refractory B-cell ALL seeking CAR T-cell therapy.
Methods: After 2 months of observation to assess patient and provider needs, the development of standardized patient and referring provider education was started. Seventeen months later, standardized triage criteria and case evaluation processes were established. A multidisciplinary care coordination model and weekly tumor board were reorganized allowing for more complex and standardized triage and clinical evaluation of each patient. This communication and these meetings are led by the nurse navigator. The nurse navigator core competencies outlined by the Oncology Nursing Society, including coordination of care, communication, education, and professionalism, were used to develop a role and standard processes to meet the needs of this patient population.2
Results: The development of this model led to a consistent decrease in preliminary patient triage time to less than 1 business day (24 hours) from initial referral. Previously, this triage time spanned from 24 hours to 5 business days. This consistently decreased triage time subjectively improved communication with referring providers and families and ultimately led to more efficient care planning.
Conclusions: Although this new process was created to better meet the needs of this pediatric population, it can be used for other programs that provide multistep, complex care to patients with high-risk conditions in which multidisciplinary teams are involved in care coordination. Consistent timelines and checkpoints in the care coordination process allow for better management of complex cases. Future work will include evaluation of nurse navigator impact on patient, family, and provider satisfaction. Additionally, regular evaluation of nurse navigator–led care planning processes will be necessary as these novel therapies move toward a commercialized setting.
References
- Maude SL, Frey N, Shaw PA, et al. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014;371:1507-1517.
- Oncology Nursing Society. 2017 Oncology Nurse Navigator Core Competencies. www.ons.org/sites/default/files/2017ONNcompetencies.pdf. Accessed July 17, 2017.
