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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA271338 | U.S. NIH Grant/Contract | View source | |
| 852857 | Other Identifier | University of Pennsylvania Institutional Review Board |
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Insufficient accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 12 weeks from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Telehealth Visit Completion | Telehealth visit completion defined as successful completion of a telehealth visit prior to biopsy | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charu Aggarwal, MD, MPH | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charu Aggarwal | Philadelphia | Pennsylvania | 19104 | United States |
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Enrollment/randomization occurred from May 8, 2023 to November 8, 2023. On November 8, 2023, the study was paused and later terminated.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All participants who 1) were diagnosed with Stage IIIB/C (with palliative intent treatment) or Stage IV non-squamous NSCLC and 2) had an initial outpatient oncology evaluation within 12 weeks of randomization. | Posted | Count of Participants | Participants | Measured up to 12 weeks from randomization |
|
1 year from randomization
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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Early termination due to insufficient accrual.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charu Aggarwal, MD, MPH | Abramson Cancer Center at the University of Pennsylvania | 215-662-6318 | charu.aggarwal@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2023 | Apr 2, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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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 |
| 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 |
| Time From Randomization to Treatment Initiation | Time from randomization to treatment initiation | Measured at 12 weeks from randomization |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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). |
|
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| Secondary | Rate of Telehealth Visit Completion | Telehealth visit completion defined as successful completion of a telehealth visit prior to biopsy | All participants randomized to telehealth who underwent biopsy. One participant was excluded from this analysis due to not having a biopsy. | Posted | Count of Participants | Participants | 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 | Posted | Count of Participants | Participants | Measured up to 12 weeks from randomization |
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| Secondary | Identification of One or More Targetable Mutations | Identification of one or more targetable mutations | Posted | Count of Participants | Participants | Measured up to 12 weeks from randomization |
|
|
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| Secondary | Timeliness of Molecularly-informed Treatment Recommendation | Time from randomization to recommendation of a molecularly-informed treatment, as documented in the EMR | Participants who received a molecularly-informed treatment recommendation up to 12 weeks from randomization. | Posted | Mean | Inter-Quartile Range | days | Measured up to 12 weeks from randomization |
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| Secondary | Overall Survival | Overall survival | All participants who 1) were diagnosed with Stage IIIB/C (with palliative intent treatment) or Stage IV non-squamous NSCLC and 2) chose active treatment, rather than hospice care, after diagnosis. | Posted | Count of Participants | Participants | Measured up to 1 year from the time of randomization to death from any cause |
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| 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) | All participants randomized to telehealth who underwent biopsy. One participant was excluded from this analysis due to not having a biopsy. | Posted | Count of Participants | Participants | Measured at 12 weeks from randomization |
|
|
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| Secondary | Time From Randomization to Treatment Initiation | Time from randomization to treatment initiation | All participants who had active treatment initiation (excludes hospice) within 12 weeks of randomization. | Posted | Mean | Inter-Quartile Range | days | Measured at 12 weeks from randomization |
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|
| 1 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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). | 3 | 7 | 0 | 7 | 0 | 7 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |