Trial Title:
Liquid Biopsy Based NGS in Newly Diagnosed NSCLC
NCT ID:
NCT05853887
Condition:
Non Small Cell Lung Cancer Metastatic
Newly Diagnosed NSCLC
Non-Squamous Non-Small Cell Neoplasm of Lung
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Next Generation Sequencing
Liquid biopsy
Newly diagnosed
Molecular testing
Plasma based next generation sequencing
Electronic health record
Nudge intervention
Targeted therapy
Behavioral economics
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
This study employs a stepped-wedge cluster randomized clinical trial design.
Randomization will occur at the group (site) level. Sites will be turned on according to
the stepped-wedge cluster randomized design but will run in parallel.
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Masking description:
This intervention is directed towards physicians. Individuals will not be randomized.
Intervention:
Intervention type:
Behavioral
Intervention name:
iNUDGE
Description:
Electronic health record nudge which prompts physicians to order plasma-based NGS testing
for eligible patients with newly diagnosed lung cancer.
Arm group label:
Penn Medicine Lancaster General Health
Arm group label:
Penn Medicine New Jersey
Arm group label:
Penn Presbyterian Medical Center
Summary:
This study expands the application of an electronic health record (EHR) "nudge" used to
prompt physicians' clinical practice to order molecular testing at the time of initial
diagnosis for patients with specific types of advanced lung cancer. The primary goal is
to have these test results available prior to starting treatment so that physicians can
make molecularly-informed treatment decisions. The second goal is to better understand
factors that contribute to whether or not the EHR-nudge implementation is successful.
Detailed description:
At the University of Pennsylvania Health System (UPHS), a behavioral economics (BE)
informed "nudge" strategy was piloted to guide physicians' clinical practice to include
concurrent use of plasma and tissue-based next generation sequencing (NGS) testing at the
time of initial diagnosis for patients with newly diagnosed metastatic non-squamous
(mNSq) non-small cell lung cancer (NSCLC). These findings have demonstrated that
behavioral, electronic health record (EHR)-based nudges are feasible and can promote
guideline concordant diagnostic testing at both community and academic sites. The
overarching goal of this current trial is to expand the application of this BE informed
nudge approach, which has been operationalized within Epic, the EHR used at UPHS, to six
satellite hospitals.
Our central hypothesis is that this approach will dramatically increase adoption of
comprehensive molecular testing and enhance the delivery of molecularly informed 1L
therapy in patients with newly diagnosed mNSq NSCLC.
Molecular testing will be defined as i) comprehensive: EGFR, ALK, BRAF, ROS1, MET, RET,
and NTRK testing, ii) incomplete: <6 genes tested, and iii) no testing performed.
Clinically actionable mutations will be defined as an alteration in one of the seven
genes on the comprehensive gene list with an FDA approved targeted therapy in the 1L
setting, plus KRAS G12C, EGFR exon 20 insertion, and ErbB2 mutations. Molecularly
informed first line therapy will be defined as one that is informed by results of NGS,
obtained by plasma, tissue or both.
Intervention
An EHR-based nudge intervention that allows for default placement of a plasma based
molecular genotyping order at time of the first new patient visit will be implemented.
Subsequently, results detected on the default plasma NGS order will be conveyed to
providers in the form of an electronic clinical decision support notification.
As part of the downstream EHR-based nudge intervention workflow, an electronic clinical
decision support (e-CDS) system for alterations detected on plasma genotyping will be
created and implemented into the EHR as a "Research (non-chargeable) Encounter" to alert
the provider team caring for the patient. This support program will be created to notify
clinicians of targetable mutations, as well as absence of mutations detected on plasma
testing as a means of improving the timely delivery of molecularly informed therapy.
Study Design
Objective 1: In a stepped wedge cluster randomized trial of patients with newly diagnosed
mNSq NSCLC, test the effectiveness of a behavioral economics (BE) informed EHR nudge
intervention to increase timely receipt of comprehensive molecular test results before 1L
therapy by integration of concurrent tissue and plasma molecular testing.
The design of this trial will include 3 clusters, representing 6 community hospitals.
There will be an initial period in which no clusters are exposed to the intervention.
Subsequently, at regular intervals (the "steps") one cluster (or a group of clusters)
will be randomized to cross from the control to the intervention under evaluation. This
process will continue until all clusters have crossed over to be exposed to the
intervention. At the end of the study there will be a period when all clusters are
exposed. Data collection will continue throughout the study, so that each cluster will
contribute observations under both control and intervention observation periods. Two
years of baseline data will be obtained from all study sites for comparison.
Objective 2: Evaluate contextual mechanisms contributing to the adoption, reach, and
effectiveness of EHR nudge interventions with a lens for health equity.
Using rigorous approaches proven successful in our prior work, the investigators will
recruit 10-15 patient and clinician participants from each site (estimated 40-60
participants total) to complete semi-structured interviews following the active trial
period. The goal of this objective is to understand contextual mechanisms (e.g., patient,
clinician, clinic, structural factors) shaping adoption, reach, and effectiveness of each
intervention and identify how response may differ by race and ethnicity, socioeconomic
status, and other key social determinants of health. These data will be analyzed using
qualitative comparative analysis, a mixed method approach well suited to identify
mechanisms in pragmatic trials with smaller sample sizes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participants with a histological, or cytological diagnosis of metastatic
non-squamous (mNSq) non-small cell lung cancer (NSCLC) who have not yet received
systemic treatment for metastatic disease.
- Participants must be seen at Lancaster General Health (LGH), Penn Presbyterian
Medical Center (PPMC), Penn Medicine Cherry Hill (PMCH), Penn Medicine Princeton
Health (PMPH), Penn Medicine Voorhees (PMV) or Penn Medicine Washington Township
(PMWT) for mNSq NSCLC.
Exclusion Criteria:
- Participants with incomplete staging information.
- Children, pregnant women, fetuses, neonates, or prisoners are not included in this
research study.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Penn Medicine Cherry Hill
Address:
City:
Cherry Hill
Zip:
08003
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shayma Kazmi, MD
Investigator:
Last name:
Shayma Kazmi, MD
Email:
Sub-Investigator
Facility:
Name:
Penn Medicine Princeton Health
Address:
City:
Plainsboro
Zip:
08536
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ramy Sedhom, MD
Investigator:
Last name:
Ramy Sedhom, MD
Email:
Sub-Investigator
Facility:
Name:
Penn Medicine Washington Township
Address:
City:
Sewell
Zip:
08080
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shayma Kazmi, MD
Investigator:
Last name:
Shayma Kazmi, MD
Email:
Sub-Investigator
Facility:
Name:
Penn Medicine Voorhees
Address:
City:
Voorhees
Zip:
08043
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shayma Kazmi, MD
Facility:
Name:
Penn Medicine Lancaster General Health
Address:
City:
Lancaster
Zip:
17602
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samuel J Kerr, MD
Investigator:
Last name:
Samuel J Kerr, MD
Email:
Sub-Investigator
Facility:
Name:
Penn Presbyterian Medical Center
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christopher A D'Avella, MD
Contact backup:
Last name:
Christine Ciunci, MD
Investigator:
Last name:
Christopher A D'Avella, MD
Email:
Sub-Investigator
Start date:
June 15, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Charu Aggarwal
Agency class:
Other
Collaborator:
Agency:
Loxo Oncology, Inc.
Agency class:
Industry
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05853887
