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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
55
Enhanced synchronous telehealth nurse navigation, compared to usual care nurse navigation, to increase timely molecularly-informed treatment recommendations through early integration of concurrent molecular testing.
Charu Aggarwal
Philadelphia, Pennsylvania, United States
Molecularly-informed Treatment Recommendations
Receipt of a molecularly-informed treatment recommendation for patients with metastatic NSq NSCLC at the time of the patient's initial oncology visit.
Time frame: Measured up to 12 weeks from randomization
Rate of Telehealth Visit Completion
Telehealth visit completion defined as successful completion of a telehealth visit prior to biopsy
Time frame: Measured up to 3 weeks from randomization
Rate of Completion of Comprehensive Molecular Testing (Tissue and/or Plasma Testing) Prior to Initiation of First Line Therapy
Rate of completion of comprehensive molecular testing (tissue and/or plasma testing) prior to initiation of first line therapy
Time frame: Measured up to 12 weeks from randomization
Identification of One or More Targetable Mutations
Identification of one or more targetable mutations
Time frame: Measured up to 12 weeks from randomization
Timeliness of Molecularly-informed Treatment Recommendation
Time from randomization to recommendation of a molecularly-informed treatment, as documented in the EMR
Time frame: Measured up to 12 weeks from randomization
Overall Survival
Overall survival
Time frame: Measured up to 1 year from the time of randomization to death from any cause
Proportion of Patients With Diagnosis Other Than Metastatic Nonsquamous NSCLC (Telehealth Arm Only)
Proportion of patients with diagnosis other than metastatic nonsquamous NSCLC (Telehealth arm only)
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Time frame: Measured at 12 weeks from randomization
Time From Randomization to Treatment Initiation
Time from randomization to treatment initiation
Time frame: Measured at 12 weeks from randomization