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

NCT05812274 | Terminated DMC

• 1 other identifier: AAAU2705
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; Immune-Checkpoint Inhibitor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Percent of study patients who experience a severe irAE (grade 3 or higher).

  2.5 years

• Time to irAE management

  2.5 years

• Time to treatment discontinuation with ICI

  2.5 years

• Number of interactions with the care team and utilization

  2.5 years

• Number of interviews/surveys completed

  2.5 years

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

Clinicians will monitor NSCLC patients on ICIs for irAEs as a standard of care using routine practices.

Interventions

Apricity C.A.R.E. Program for Cancer Adverse events Rapid Evaluation OTHER

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.

Also known as: Apricity CARE program

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Stand Up To Cancer: collaborator

Study Sites (4)

Montefiore Health Center

New York, New York, 10029, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

NYU Medical Center

New York, New York, 10029, United States

Location

Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center

New York, New York, 10032, United States

Location

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MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Brian Henick, MD

  Assistant Professor of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine at the Columbia University Medical Center

Model Details: 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.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 13, 2023
• Study Start: May 31, 2023
• Primary Completion: July 30, 2025
• Study Completion: October 24, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (4)