The purpose of this trial is to study the effectiveness of the AprictyRxTM care service to improve treatment outcomes of ethnic/racial minority N.S.C.L.C. patients receiving standard of care immunotherapy, and reduce the frequency of healthcare system interactions.
Immune checkpoint inhibitors (I.C.I.) targeting the PD-1/PD-L1 axis have changed the treatment landscape of non-small cell lung cancer (N.S.C.L.C.). After demonstrating improved efficacy and tolerability compared to standard chemotherapy in several large clinical trials, these novel drugs are now F.D.A. approved in multiple treatment settings. With the increase in I.C.I. use, the incidence of immune-related adverse effects (irAEs) has also risen, occurring in up to 16% of ICI-treated patients. Prompt recognition and timely management are necessary to avert potential poor outcomes from direct toxicity and/or early treatment discontinuation. However, rapid adoption of I.C.I.s may limit healthcare providers' experience and comfort with managing important irAEs. Additionally, existing barriers to access care that disproportionately impact racial and ethnic minority patients may amplify the inability to manage patients on I.C.I.s effectively. Using technologically-enabled health interventions in a culturally competent manner can improve access to health care resources and reduce health disparities. These platforms need to be optimized at the literacy level of underserved minority communities and can be adapted to meet the community's needs. Recently, technology-enabled services focused on patient-reported outcomes have garnered growing interest in oncology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
The Apricity CARE program for Cancer Adverse events Rapid Evaluation is a cloud-based 24/7 on-demand clinical coverage service, delivered exclusively via the ApricityRx digital care platform by certified and licensed healthcare professionals who are trained to monitor patient's symptoms and conduct standardized triage following guideline-based or protocol-specified pathways with 3 parts: * ApricityCare™ Mobile Application - to collect health data (PGHD) on biometrics and self-reported symptoms (PRO) of symptoms and potential side effects at home, in between doctors' visits, and offers educational content in video. * ApricityOncology™ Web-based Application - to provide authorized healthcare providers an organized, longitudinal and summarized view of a patient's pertinent cancer history and real world PGHD for purpose of symptom monitoring. * ApricityManage™ Dashboard - a dashboard intended for administrators, sponsors or funders to track program status.
Montefiore Health Center
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
NYU Medical Center
New York, New York, United States
Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Mean Likert-type scale score
Two focus group discussions (FGDs), stratified on a Likert-type scale based on the frequency of utilization, to determine factors related to usage of ApricityCare app and utilization of the CARE monitoring service (Run-in phase). To assess factors related to suboptimal and optimal use of the ApricityCare app and the CARE monitoring service, collectively "the Apricity CARE program".
Time frame: 2 years
Percent of study patients who experienced treatment delay/discontinuation
To determine the impact of the the Apricity CARE program on immunotherapy toxicity monitoring for N.S.C.L.C. patients receiving immunotherapy in a highly diverse New York City community. Immune Checkpoint Inhibitor (ICI) treatment delay or discontinuation is defined as a gap between doses of ICI beyond 60 days and/or the initiation of another cancer therapy without evidence of disease progression.
Time frame: 2 years
Percent of study patients who experience a severe irAE (grade 3 or higher).
To assess the percent of study patients who experience a severe irAE (grade 3 or higher) while on study. Information about individual treatment toxicities (i.e., type, frequency) will be obtained and recorded from the ApricityRxTM platform and patient's clinical note. Toxicity grade will be assigned using the NCI CTCAE v5.0 and tallied.
Time frame: 2.5 years
Time to irAE management
To quantify time to irAE management with ICI. This will be defined as the time from the onset of irAE to time of active intervention (i.e., change in administration schedule, new prescription of supportive medication, telephone counseling about symptoms, unscheduled visits or referrals). Information will be obtained and recorded from the ApricityRxTM platform and patient's clinical note, and tallied. Unit measured in days.
Time frame: 2.5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time to treatment discontinuation with ICI
To quantify time to irAE management with ICI. This will be determined as starting date of ICI to date of the last dose of ICI for any reason specified by patient's EMR. Information will be obtained and recorded from the ApricityRxTM platform and patient's clinical note, and tallied. Unit measured in days.
Time frame: 2.5 years
Number of interactions with the care team and utilization
This will be quantified as the number of clinical interactions between patients and providers from the patient's EMR and will include telephone encounters, unscheduled clinic visits, ED visits, hospital admissions - total will be tallied.
Time frame: 2.5 years
Number of interviews/surveys completed
Patient and provider experience will be assessed with focus group discussions (FGDs), semi-structured interviews, and surveys
Time frame: 2.5 years