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

Study 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.

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

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Other: Telehealth


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telehealth<br>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. | Other: Telehealth<br>* 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.<br>|
| No Intervention: Usual Care<br>Patients in the usual care arm will receive a telephone call from a trained lung cancer nurse navigator after biopsy, as is typical at Penn Medicine, to 1) review the roles of clinicians on the medical oncology care team; 2) provide brief education on lung cancer; and 3) review the patient's diagnostic history and coordinate collection or completion of imaging required for guideline-recommended cancer staging. At the initial in-person oncology visit, the oncologist may choose to order plasma-based testing if appropriate (and if not already ordered or pending). | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Measured up to 6 weeks from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of telehealth visit completion | Telehealth visit completion defined as successful completion of a telehealth visit prior to in-person consultation | 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 | Measured up to 12 weeks from randomization | 
| Identification of one or more targetable mutations | Identification of one or more targetable mutations | 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 | Measured up to 12 weeks from randomization | 
| Overall survival | Overall survival | Measured up to 1 year from the time of randomization to death from any cause | 
| Intervention costs | Intervention costs | Measured at the time of initiation of first line therapy | 
| 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) | Measured at 12 weeks from randomization | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Molecular Testing, Lung Cancer, Telehealth, Liquid Biopsy