Non-small Cell Lung Cancer
Conditions
Keywords
Molecular Testing, Lung Cancer, Telehealth, Liquid Biopsy
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.
Interventions
OTHERTelehealth
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.
Sponsors
National Cancer Institute (NCI)
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Molecularly-informed Treatment Recommendations | Measured up to 12 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | Measured up to 12 weeks from randomization | Identification of one or more targetable mutations |
| Timeliness of Molecularly-informed Treatment Recommendation | Measured up to 12 weeks from randomization | Time from randomization to recommendation of a molecularly-informed treatment, as documented in the EMR |
| Rate of Telehealth Visit Completion | Measured up to 3 weeks from randomization | Telehealth visit completion defined as successful completion of a telehealth visit prior to biopsy |
| Proportion of Patients With Diagnosis Other Than Metastatic Nonsquamous NSCLC (Telehealth Arm Only) | Measured at 12 weeks from randomization | Proportion of patients with diagnosis other than metastatic nonsquamous NSCLC (Telehealth arm only) |
| Time From Randomization to Treatment Initiation | Measured at 12 weeks from randomization | Time from randomization to treatment initiation |
| Overall Survival | Measured up to 1 year from the time of randomization to death from any cause | Overall survival |
Countries
United States
Participant flow
Recruitment details
Enrollment/randomization occurred from May 8, 2023 to November 8, 2023. On November 8, 2023, the study was paused and later terminated.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 28 |
| 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). | 27 |
| Total | 55 |
Baseline characteristics
| Characteristic | Telehealth | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 68 years | 68 years | 70 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 53 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 14 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 16 Participants | 36 Participants | 20 Participants |
| Region of Enrollment United States | 28 participants | 55 participants | 27 participants |
| Sex: Female, Male Female | 15 Participants | 27 Participants | 12 Participants |
| Sex: Female, Male Male | 13 Participants | 28 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 6 | 3 / 7 |
| other Total, other adverse events | 0 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 |
Outcome results
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.
Time frame: Measured up to 12 weeks from randomization
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth | Molecularly-informed Treatment Recommendations | 2 Participants |
| Usual Care | Molecularly-informed Treatment Recommendations | 2 Participants |
Secondary
Identification of One or More Targetable Mutations
Identification of one or more targetable mutations
Time frame: Measured up to 12 weeks from randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth | Identification of One or More Targetable Mutations | 2 Participants |
| Usual Care | Identification of One or More Targetable Mutations | 2 Participants |
Secondary
Overall Survival
Overall survival
Time frame: Measured up to 1 year from the time of randomization to death from any cause
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Telehealth | Overall Survival | Alive | 5 Participants |
| Telehealth | Overall Survival | Deceased | 1 Participants |
| Usual Care | Overall Survival | Alive | 4 Participants |
| Usual Care | Overall Survival | Deceased | 2 Participants |
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)
Time frame: Measured at 12 weeks from randomization
Population: All participants randomized to telehealth who underwent biopsy. One participant was excluded from this analysis due to not having a biopsy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth | Proportion of Patients With Diagnosis Other Than Metastatic Nonsquamous NSCLC (Telehealth Arm Only) | 21 Participants |
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
Time frame: Measured up to 12 weeks from randomization
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth | Rate of Completion of Comprehensive Molecular Testing (Tissue and/or Plasma Testing) Prior to Initiation of First Line Therapy | 26 Participants |
| Usual Care | Rate of Completion of Comprehensive Molecular Testing (Tissue and/or Plasma Testing) Prior to Initiation of First Line Therapy | 12 Participants |
Secondary
Rate of Telehealth Visit Completion
Telehealth visit completion defined as successful completion of a telehealth visit prior to biopsy
Time frame: Measured up to 3 weeks from randomization
Population: All participants randomized to telehealth who underwent biopsy. One participant was excluded from this analysis due to not having a biopsy.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Telehealth | Rate of Telehealth Visit Completion | 25 Participants |
Secondary
Time From Randomization to Treatment Initiation
Time from randomization to treatment initiation
Time frame: Measured at 12 weeks from randomization
Population: All participants who had active treatment initiation (excludes hospice) within 12 weeks of randomization.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telehealth | Time From Randomization to Treatment Initiation | 27.6 days |
| Usual Care | Time From Randomization to Treatment Initiation | 50.3 days |
Secondary
Timeliness of Molecularly-informed Treatment Recommendation
Time from randomization to recommendation of a molecularly-informed treatment, as documented in the EMR
Time frame: Measured up to 12 weeks from randomization
Population: Participants who received a molecularly-informed treatment recommendation up to 12 weeks from randomization.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Telehealth | Timeliness of Molecularly-informed Treatment Recommendation | 17.6 days |
| Usual Care | Timeliness of Molecularly-informed Treatment Recommendation | 38.5 days |