Clinical trial NCT05790460: Telehealth Based Synchronous Navigation to Improve Molecularly-Informed Care for Patients With Lung Cancer
Official title: Telehealth Based Synchronous Navigation to Improve Molecularly-Informed Care for Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: Molecular Testing
Lung Cancer
Telehealth
Liquid Biopsy
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-03-30
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Molecularly-informed Treatment Recommendations
timeFrame: Measured up to 12 weeks from randomization
Secondary outcomes:
measure: Rate of Telehealth Visit Completion
timeFrame: Measured up to 3 weeks from randomization
measure: Rate of Completion of Comprehensive Molecular Testing (Tissue and/or Plasma Testing) Prior to Initiation of First Line Therapy
timeFrame: Measured up to 12 weeks from randomization
measure: Identification of One or More Targetable Mutations
timeFrame: Measured up to 12 weeks from randomization
measure: Timeliness of Molecularly-informed Treatment Recommendation
timeFrame: Measured up to 12 weeks from randomization
measure: Overall Survival
timeFrame: Measured up to 1 year from the time of randomization to death from any cause
measure: Proportion of Patients With Diagnosis Other Than Metastatic Nonsquamous NSCLC (Telehealth Arm Only)
timeFrame: Measured at 12 weeks from randomization
measure: Time From Randomization to Treatment Initiation
timeFrame: Measured at 12 weeks from randomization
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Charu Aggarwal
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Charu Aggarwal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: