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

NCT05790460 | Terminated Results

• 3 other identifiers: UPCC 22522P50CA271338852857
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-small Cell Lung Cancer

Keywords

Molecular Testing; Lung Cancer; Telehealth; Liquid Biopsy

Outcome Measures

Primary Outcomes (1)

• 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 12 weeks from randomization

Secondary Outcomes (7)

• Rate of Telehealth Visit Completion

  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

  Measured up to 12 weeks from randomization

• Identification of One or More Targetable Mutations

  Measured up to 12 weeks from randomization

• Timeliness of Molecularly-informed Treatment Recommendation

  Measured up to 12 weeks from randomization

• Overall Survival

  Measured up to 1 year from the time of randomization to death from any cause

Study Arms (2)

Telehealth

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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).

Interventions

Telehealth OTHER

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.

Telehealth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Are not suspected to have locally advanced/metastatic NSCLC
• Have a concurrent active malignancy

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Charu Aggarwal

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

Early termination due to insufficient accrual.

Results Point of Contact

• Title: Charu Aggarwal, MD, MPH
• Organization: Abramson Cancer Center at the University of Pennsylvania

charu.aggarwal@pennmedicine.upenn.edu

215-662-6318

Study Officials

• Charu Aggarwal, MD, MPH

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: March 30, 2023
• Study Start: May 8, 2023
• Primary Completion: January 11, 2024
• Study Completion: November 9, 2024
• Last Updated: April 22, 2025
• Results First Posted: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)