Apricity CARE to Improve ICI Outcomes of Ethnic/Racial Minority NSCLC Patients

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
A Phase IV Study of Apricity C.A.R.E. Program for Cancer Adverse Events Rapid Evaluation to Improve Treatment Outcomes of Ethnic/Racial Minority Non-small Cell Lung Cancer (NSCLC) Patients Receiving Immunotherapy

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Other: Apricity C.A.R.E. Program for Cancer Adverse events Rapid Evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥ 18 years Confirmed NSCLC diagnosis Prescribed treatment with immune-checkpoint inhibitor, including in combination with chemotherapy Ability to understand and the willingness to sign a written informed consent document Self-identification as a member of an ethnic minority or underserved population. Exclusion Criteria: An individual with presence of any medical, psychological, or social condition that, in the opinion of the investigator would preclude participation in this study. Patients enrolled in other interventional clinical trials at the time of screening will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: People who meet eligibility requirements and provide informed consent will be randomly allocated to the two arms with a 1:1 allocation ratio.The randomization will match patients according to: 1) age, 2) performance status (ECOG <2 vs >=2) and 3) receiving ICI monotherapy vs. ICI plus chemotherapy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Participants are provided with ApricityRx digital solution with pulse oximeters and 24/7 C.A.R.E. (Cancer Adverse event Rapid Evaluation) to monitor and capture ePRO, identify onset or progression of symptoms verified by nurse triage, trigger intervention by the study team. | Other: Apricity C.A.R.E. Program for Cancer Adverse events Rapid Evaluation<br>* 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.<br>* Other names: Apricity CARE program;|
| No Intervention: Control Arm<br>Clinicians will monitor NSCLC patients on ICIs for irAEs as a standard of care using routine practices. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2.5 years | 
| 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. | 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. | 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 | 2.5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non Small Cell Lung Cancer, Immune-Checkpoint Inhibitor