Clinical trial NCT05812274: Apricity CARE to Improve ICI Outcomes of Ethnic/Racial Minority NSCLC Patients
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Non Small Cell Lung Cancer
Keywords: Non Small Cell Lung Cancer
Immune-Checkpoint Inhibitor
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2023-04-13
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Primary outcomes:
measure: Mean Likert-type scale score
timeFrame: 2 years
measure: Percent of study patients who experienced treatment delay/discontinuation
timeFrame: 2 years
Secondary outcomes:
measure: Percent of study patients who experience a severe irAE (grade 3 or higher).
timeFrame: 2.5 years
measure: Time to irAE management
timeFrame: 2.5 years
measure: Time to treatment discontinuation with ICI
timeFrame: 2.5 years
measure: Number of interactions with the care team and utilization
timeFrame: 2.5 years
measure: Number of interviews/surveys completed
timeFrame: 2.5 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Montefiore Health Center
state: New York
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: NYU Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center, Herbert Irving Comprehensive Cancer Center
state: New York
Study officials:
affiliation: Assistant Professor of Medicine
name: Brian Henick, MD
role: PRINCIPAL_INVESTIGATOR
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