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

Non-small Cell Lung Cancer Clinical Trial

— TESTING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05790460
• Other study ID #: UPCC 22522
• Secondary ID: P50CA27133885285
• Status: Recruiting
• Phase: N/A
• Start date: May 8, 2023
• Est. completion date: September 20, 2025

Study information

• Verified date: May 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Jennifer Steltz
• Phone: 215-573-2593
• Email: jennifer.steltz[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: September 20, 2025
• Est. primary completion date: September 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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:

• Are not suspected to have locally advanced/metastatic NSCLC

• Have a concurrent active malignancy

Related Conditions & MeSH terms

• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Charu Aggarwal	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Identification of one or more targetable mutations	Identification of one or more targetable mutations	Measured up to 12 weeks from randomization
Secondary	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
Secondary	Overall survival	Overall survival	Measured up to 1 year from the time of randomization to death from any cause
Secondary	Intervention costs	Intervention costs	Measured at the time of initiation of first line therapy
Secondary	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