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

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth
Sponsored by
Abramson Cancer Center at Penn Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Non-small Cell Lung Cancer focused on measuring Molecular Testing, Lung Cancer, Telehealth, Liquid Biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charu AggarwalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Telehealth

Usual Care

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Rate of telehealth visit completion
Telehealth visit completion defined as successful completion of a telehealth visit prior to in-person consultation
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
Identification of one or more targetable mutations
Identification of one or more targetable mutations
Timeliness of molecularly-informed treatment recommendation
Time from randomization to recommendation of a molecularly-informed treatment, as documented in the EMR
Overall survival
Overall survival
Intervention costs
Intervention costs
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)

Full Information

First Posted
February 20, 2023
Last Updated
May 24, 2023
Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05790460
Brief Title
Telehealth Based Synchronous Navigation to Improve Molecularly-Informed Care for Patients With Lung Cancer
Acronym
TESTING
Official Title
Telehealth Based Synchronous Navigation to Improve Molecularly-Informed Care for Patients With Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
September 20, 2024 (Anticipated)
Study Completion Date
September 20, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Molecular Testing, Lung Cancer, Telehealth, Liquid Biopsy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
138 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telehealth
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Telehealth
Intervention Description
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.
Primary Outcome Measure Information:
Title
Molecularly-informed treatment recommendations
Description
Receipt of a molecularly-informed treatment recommendation for patients with metastatic NSq NSCLC at the time of the patient's initial oncology visit.
Time Frame
Measured up to 6 weeks from randomization
Secondary Outcome Measure Information:
Title
Rate of telehealth visit completion
Description
Telehealth visit completion defined as successful completion of a telehealth visit prior to in-person consultation
Time Frame
Measured up to 3 weeks from randomization
Title
Rate of completion of comprehensive molecular testing (tissue and/or plasma testing) prior to initiation of first line therapy
Description
Rate of completion of comprehensive molecular testing (tissue and/or plasma testing) prior to initiation of first line therapy
Time Frame
Measured up to 12 weeks from randomization
Title
Identification of one or more targetable mutations
Description
Identification of one or more targetable mutations
Time Frame
Measured up to 12 weeks from randomization
Title
Timeliness of molecularly-informed treatment recommendation
Description
Time from randomization to recommendation of a molecularly-informed treatment, as documented in the EMR
Time Frame
Measured up to 12 weeks from randomization
Title
Overall survival
Description
Overall survival
Time Frame
Measured up to 1 year from the time of randomization to death from any cause
Title
Intervention costs
Description
Intervention costs
Time Frame
Measured at the time of initiation of first line therapy
Title
Proportion of patients with diagnosis other than metastatic nonsquamous NSCLC (Telehealth arm only)
Description
Proportion of patients with diagnosis other than metastatic nonsquamous NSCLC (Telehealth arm only)
Time Frame
Measured at 12 weeks from randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Steltz
Phone
215-573-2593
Email
jennifer.steltz@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn Wainwright, MS
Phone
215-615-4226
Email
jocelyn.wainwright@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charu Aggarwal, MD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charu Aggarwal
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charu Aggarwal, MD, MPH
Phone
215-662-6318
First Name & Middle Initial & Last Name & Degree
Charu Aggarwal, MD, MPH
First Name & Middle Initial & Last Name & Degree
Jeffrey Thompson, MD, MTR
First Name & Middle Initial & Last Name & Degree
Anil Vachani, MD, MS
First Name & Middle Initial & Last Name & Degree
Justin Bekelman, MD
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD, MBA
First Name & Middle Initial & Last Name & Degree
Katharine Rendle, PhD,MSW,MPH
First Name & Middle Initial & Last Name & Degree
Marilyn Schapira, MD, MPH
First Name & Middle Initial & Last Name & Degree
Alisa Stephens-Shields, PhD
First Name & Middle Initial & Last Name & Degree
Andy Tan, PhD
First Name & Middle Initial & Last Name & Degree
Megan Roy, MSN, RN, OCN
First Name & Middle Initial & Last Name & Degree
Christoph Hutchinson, MD
First Name & Middle Initial & Last Name & Degree
David DiBardino, MD
First Name & Middle Initial & Last Name & Degree
Andrew Haas, MD, PhD
First Name & Middle Initial & Last Name & Degree
Anthony Lanfranco, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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