TESTING: Telehealth Based Synchronous Navigation to Improve Molecularly-Informed Care for Patients With Lung Cancer
Study Details
Study Description
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 (Objective 1). Additionally, we will evaluate contextual mechanisms contributing to the effectiveness of synchronous telehealth nurse navigation through surveys and interviews of patients and clinicians (Objective 2).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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). Our 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. This trial will allow us to assess multilevel determinants shaping the effectiveness and equity of telehealth strategies for cancer treatment initiation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: Telehealth
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.
|
| No Intervention: Usual Care 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). |
Outcome Measures
Primary Outcome Measures
- Objective 1: Molecularly-informed treatment recommendations [Measured up to 6 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.
- Objective 2: Individual and contextual factors shaping trial effectiveness and patient experience [Assessed up to 1 year from randomization]
Treatment knowledge, medical mistrust, clinical beliefs, organizational climate, patient-centered communication, financial toxicity, and knowledge of genetic testing.
Secondary Outcome Measures
- Telehealth visit completion [Measured up to 3 weeks from randomization]
Telehealth visit completion
- Completion of comprehensive molecular testing (tissue and/or plasma testing) prior to initiation of first line therapy [Measured up to 12 weeks from randomization]
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 initiation [Measured up to 12 weeks from randomization]
Time from randomization to molecularly-informed treatment initiation
- 1-year overall survival [Measured at 1 year from randomization]
1-year overall survival
- Intervention costs [Measured at the time of initiation of first line therapy]
Intervention costs
- Diagnosis other than metastatic NSq NSCLC (Telehealth arm only) [Measured at 12 weeks from randomization]
Diagnosis other than metastatic NSq NSCLC (Telehealth arm only)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Objective 1: Patients will be eligible for the randomized clinical trial if they:
-
are aged 18 years or older
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based on cross-sectional imaging, are suspected to have locally advanced/metastatic NSCLC (as determined by the evaluating clinician)
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complete an appointment in the lung cancer evaluation clinic
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proceed with tissue biopsy after completion of initial clinical visit.
- Objective 2:
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Patients will be eligible if they were selected for participation in the pilot trial.
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Clinicians will be eligible if their area of expertise relates to the protocol topic (e.g., oncologists, nurses, clinical leads).
Exclusion Criteria:
- Objective 1: Patients will be ineligible for the pilot randomized clinical trial if they:
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are not suspected to have locally advanced/metastatic NSCLC; or
-
do not complete an appointment in the lung cancer evaluation clinic; or
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do not proceed with tissue biopsy after completion of clinical visit; or
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have a concurrent active malignancy.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charu Aggarwal | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Abramson Cancer Center at Penn Medicine
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Charu Aggarwal, MD, MPH, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 852857
- P50CA271338
- UPCC 22522