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Special Care Service for Lung Cancer

N/A

Waitlist Available

Led By Brian Henick, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age≥ 18 years

Confirmed NSCLC diagnosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2.5 years

Awards & highlights

Study Summary

This trial studies if a special care service can help cancer patients from minority backgrounds get better treatment and reduce how much they need to go to the doctor.

Who is the study for?

This trial is for adults over 18 with confirmed non-small cell lung cancer (NSCLC) who are receiving immunotherapy and identify as part of an ethnic minority or underserved group. They must understand the study and agree to participate. Those in other clinical trials or with conditions that may hinder participation cannot join.Check my eligibility

What is being tested?

The Apricity C.A.R.E. Program is being tested to see if it can improve treatment results for NSCLC patients from racial/ethnic minorities on immunotherapy, aiming to reduce their need for frequent healthcare visits.See study design

What are the potential side effects?

Since this trial focuses on a care service program rather than a drug, there aren't direct side effects like those seen with medications. However, interactions with the healthcare system could change.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with non-small cell lung cancer.

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I am being treated with drugs that boost my immune system to fight cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean Likert-type scale score

Percent of study patients who experienced treatment delay/discontinuation

Secondary outcome measures

Number of interactions with the care team and utilization

Number of interviews/surveys completed

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

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention ArmExperimental Treatment1 Intervention

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.

Group II: Control ArmActive Control1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,551 Total Patients Enrolled

Brian Henick, MDPrincipal InvestigatorAssistant Professor of Medicine

4 Previous Clinical Trials

185 Total Patients Enrolled

Media Library

Intervention Arm Clinical Trial Eligibility Overview. Trial Name: NCT05812274 — N/A

Non-Small Cell Lung Cancer Research Study Groups: Control Arm, Intervention Arm

Non-Small Cell Lung Cancer Clinical Trial 2023: Intervention Arm Highlights & Side Effects. Trial Name: NCT05812274 — N/A

Intervention Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05812274 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings to join this trial at the moment?

"According to clinicaltrials.gov, this research project is no longer actively seeking participants; the initial post was made on April 1st 2023 and it last received changes on March 31st 2023. Nonetheless, there are still 2,067 other studies recruiting around the world at present."

Answered by AI

What results is this research hoping to achieve?

"This two-year study seeks to measure the prevalence of treatment delays or discontinuations in patients receiving this medication. Additionally, it will provide insight into the time taken for irAE management, duration of ICI until discontinued, and total interactions between patient and care teams. Data collection activities include monitoring ApricityRxTM platform information as well as clinical notes from patient records with units measured by days."

Answered by AI

Recent research and studies

New England Journal of MedicineJournal

Nivolumab Plus Ipilimumab in Advanced Non–small-cell Lung Cancer

Hellmann, Matthew D., Luis Paz-Ares, Reyes Bernabe Caro, Bogdan Zurawski, Sang-We Kim, Enric Carcereny Costa, Keunchil Park, et al.. 2019. “Nivolumab Plus Ipilimumab in Advanced Non–small-cell Lung Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1910231.

clinicaltrials.govStudy

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

Brian Henick, MD 2023. "Apricity CARE to Improve ICI Outcomes of Ethnic/Racial Minority NSCLC Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05812274.