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Clinical Trials/NCT05790460
NCT05790460
Terminated
N/A

Telehealth Based Synchronous Navigation to Improve Molecularly-Informed Care for Patients With Lung Cancer

Abramson Cancer Center at Penn Medicine1 site in 1 country55 target enrollmentMay 8, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Non-small Cell Lung Cancer
Sponsor
Abramson Cancer Center at Penn Medicine
Enrollment
55
Locations
1
Primary Endpoint
Molecularly-informed Treatment Recommendations
Status
Terminated
Last Updated
last year

Overview

Brief Summary

The goal of this trial is to design and test a telehealth nurse navigation intervention for patients with suspected locally advanced/metastatic NSCLC to improve timely molecularly-informed treatment recommendations through early integration of concurrent molecular testing.

Detailed Description

The overarching goal of this pilot trial is to design and test a nurse navigation intervention delivered via telehealth for patients with suspected locally advanced/metastatic NSCLC to improve timely molecularly-informed treatment recommendations through early integration of concurrent molecular testing (i.e., tumor tissue and plasma-based molecular testing or plasma only when tumor tissue is insufficient/unavailable). The central hypothesis is that providing telehealth nurse navigation to support completion of concurrent molecular testing will result in higher rates of comprehensive testing, improved timeliness of molecularly-informed treatment recommendations (primary endpoint), earlier initiation of molecularly-informed treatment, more meaningful patient-clinician communication, and higher levels of overall satisfaction among patients and clinicians. Drawing from systematic evidence on the role of navigation for coordination of cancer care and informed by insights from communication science and behavioral economics, the specific telehealth strategy to be tested is synchronous telehealth nurse navigation in combination with default ordering of plasma-based testing.

Registry
clinicaltrials.gov
Start Date
May 8, 2023
End Date
November 9, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Charu Aggarwal

Associate Professor of Medicine

Abramson Cancer Center at Penn Medicine

Eligibility Criteria

Inclusion Criteria

  • Aged 18 years or older
  • Based on cross-sectional imaging, suspected to have locally advanced/metastatic NSCLC (as determined by the evaluating clinician)
  • Scheduled for an appointment in the lung cancer evaluation clinic

Exclusion Criteria

  • Are not suspected to have locally advanced/metastatic NSCLC
  • Have a concurrent active malignancy

Outcomes

Primary Outcomes

Molecularly-informed Treatment Recommendations

Time Frame: Measured up to 12 weeks from randomization

Receipt of a molecularly-informed treatment recommendation for patients with metastatic NSq NSCLC at the time of the patient's initial oncology visit.

Secondary Outcomes

  • Rate of Telehealth Visit Completion(Measured up to 3 weeks from randomization)
  • Proportion of Patients With Diagnosis Other Than Metastatic Nonsquamous NSCLC (Telehealth Arm Only)(Measured at 12 weeks from randomization)
  • Rate of Completion of Comprehensive Molecular Testing (Tissue and/or Plasma Testing) Prior to Initiation of First Line Therapy(Measured up to 12 weeks from randomization)
  • Identification of One or More Targetable Mutations(Measured up to 12 weeks from randomization)
  • Timeliness of Molecularly-informed Treatment Recommendation(Measured up to 12 weeks from randomization)
  • Overall Survival(Measured up to 1 year from the time of randomization to death from any cause)
  • Time From Randomization to Treatment Initiation(Measured at 12 weeks from randomization)

Study Sites (1)

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