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

Not Applicable

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Telehealth	Telehealth	Patients in the intervention arm will be scheduled for an enhanced synchronous telehealth visit with a trained lung cancer nurse navigator prior to tissue biopsy. The enhanced synchronous telehealth visit will ideally occur between the initial clinical appointment and diagnostic biopsy (typically a period between two and seven days). In addition to the activities conducted as part of usual care, the nurse navigator will: 1) provide more detailed and individualized education on lung cancer and the rationale for comprehensive molecular testing, including plasma-based tests; and 2) if the patient agrees to testing, pend a default order for plasma-based molecular testing (if not already ordered) for the clinician to sign and arrange for phlebotomy to be performed at the time of the patient's tissue biopsy.

Primary Outcome Measures

Name	Time	Method
Molecularly-informed Treatment Recommendations	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 Outcome Measures

Name	Time	Method
Rate of Telehealth Visit Completion	Measured up to 3 weeks from randomization	Telehealth visit completion defined as successful completion of a telehealth visit prior to biopsy
Proportion of Patients With Diagnosis Other Than Metastatic Nonsquamous NSCLC (Telehealth Arm Only)	Measured at 12 weeks from randomization	Proportion of patients with diagnosis other than metastatic nonsquamous NSCLC (Telehealth arm only)
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	Rate of completion of comprehensive molecular testing (tissue and/or plasma testing) prior to initiation of first line therapy
Identification of One or More Targetable Mutations	Measured up to 12 weeks from randomization	Identification of one or more targetable mutations
Timeliness of Molecularly-informed Treatment Recommendation	Measured up to 12 weeks from randomization	Time from randomization to recommendation of a molecularly-informed treatment, as documented in the EMR
Overall Survival	Measured up to 1 year from the time of randomization to death from any cause	Overall survival
Time From Randomization to Treatment Initiation	Measured at 12 weeks from randomization	Time from randomization to treatment initiation