Trial Title:
Apricity CARE to Improve ICI Outcomes of Ethnic/Racial Minority NSCLC Patients
NCT ID:
NCT05812274
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Non Small Cell Lung Cancer
Immune-Checkpoint Inhibitor
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Apricity C.A.R.E. Program for Cancer Adverse events Rapid Evaluation
Description:
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.
Arm group label:
Intervention Arm
Other name:
Apricity CARE program
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Montefiore Health Center
Address:
City:
New York
Zip:
10029
Country:
United States
Contact:
Last name:
Balazs Halmos, MD
Email:
bahalmos@montefiore.org
Investigator:
Last name:
Balazs Halmos, MD
Email:
Principal Investigator
Investigator:
Last name:
Enrico Castellucci, MD
Email:
Sub-Investigator
Facility:
Name:
Mount Sinai School of Medicine
Address:
City:
New York
Zip:
10029
Country:
United States
Contact:
Last name:
Rajwanth Veluswamy, MD
Phone:
212-824-8580
Email:
rajwanth.veluswamy@mssm.edu
Investigator:
Last name:
Rajwanth Veluswamy, MD
Email:
Principal Investigator
Investigator:
Last name:
Bailey Gleason Fitzgerald, MD
Email:
Sub-Investigator
Facility:
Name:
NYU Medical Center
Address:
City:
New York
Zip:
10029
Country:
United States
Contact:
Last name:
Vamsidhar Velcheti, MD
Email:
vamsidhar.velcheti@nyulangone.org
Investigator:
Last name:
Vamsidhar Velcheti, MD
Email:
Principal Investigator
Investigator:
Last name:
Salman Punekar, MD
Email:
Sub-Investigator
Facility:
Name:
Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center
Address:
City:
New York
Zip:
10032
Country:
United States
Contact:
Last name:
Brian Henick, MD
Investigator:
Last name:
Catherine Shu, MD
Email:
Sub-Investigator
Investigator:
Last name:
Benjamin Herzberg, MD
Email:
Sub-Investigator
Investigator:
Last name:
Brain Henick, MD
Email:
Principal Investigator
Start date:
April 2023
Completion date:
August 2025
Lead sponsor:
Agency:
Columbia University
Agency class:
Other
Source:
Columbia University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05812274
