Carcinoma, Non-small-cell Lung, Coin Lesion, Pulmonary, Lung Neoplasms, Solitary Pulmonary Nodule
Conditions
Brief summary
This study will compare two clinically accepted protocols for surveillance imaging in individuals who are found to have a small pulmonary nodule on chest computed tomography (CT) scans.
Detailed description
The investigators will conduct an unblinded, prospective, pragmatic, cluster-randomized, comparative effectiveness trial of more intensive versus less intensive CT surveillance of patients found to have small pulmonary nodules in diverse health care settings. The goal of this pragmatic clinical trial is to identify the surveillance strategy that will maximize early diagnosis for individuals with cancerous nodules, while minimizing unnecessary surveillance of patients without cancer that can result in emotional stress, exposure to harmful ionizing radiation, and the discovery of incidental findings that may lead to unnecessary treatment.
Interventions
OTHERMore Frequent Surveillance Strategy
Chest CT scans to be repeated at 3, 6, 12 and/or 24 months, depending on patient risk factors and nodule size and attenuation (density)
OTHERLess Frequent Surveillance Strategy
Chest CT scans to be repeated at 3, 6, 12 and/or 24 months, depending on patient risk factors and nodule size and attenuation (density). Overall, participants in the less frequent arm are expected to undergo 30% fewer surveillance imaging tests.
Sponsors
Patient-Centered Outcomes Research Institute
University of California, Davis
University of California, San Francisco
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
The target population includes adults with small lung nodules that may represent a new diagnosis of lung cancer, who typically would be managed by CT surveillance in usual clinical practice. Thus, we will enroll all patients: * aged ≥35 years * at least one nodule measuring ≤15 mm in average diameter on chest CT.
Exclusion criteria
* Pregnant Women * Age \<35 years * Known diagnosis of cancer (except non-melanoma skin cancer) within 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of cancerous nodules with tumor (T) stage greater than T1a disease by the AJCC staging system, 7th edition | 24 months after enrollment | Among individuals with small pulmonary nodules identified either incidentally or by screening, compare more versus less intensive surveillance to determine the number of cancerous nodules that progress beyond T stage T1a. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival time from date of cancer diagnosis until death or end of study | Up to 4 years | Ongoing, final analysis in year 5 |
| Emotional distress, measured with the Impact of Events Scale | Measured at 2 months, 13 months, and 25 months following nodule identification | Compare patient-reported emotional distress |
| Anxiety, measured with the State Anxiety Inventory, 6-item | Measured at 2 months, 13 months, and 25 months following nodule identification | Compare patient-reported anxiety |
| General health status, measured with a single question | Measured at 2 months, 13 months, and 25 months following nodule identification | Compare patient-reported general health status |
| Number of days from date of nodule identification to date of cancer diagnosis | Up to 2 years | Ongoing, final analysis in year 5 |
| Exposure to ionizing radiation, using the computed tomography dose index (CTDIvol), measured in mGy (milliGray) | Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up | Compare effective radiation doses received. |
| Exposure to ionizing radiation, using the the dose length product (DLP), measured in mGy*cm | Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up | Compare effective radiation doses received. |
| Numbers of CT scans recommended by the assigned protocol that were not ordered by the ordering provider, and/or not completed by the patient | Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up | Compare adherence to the recommended protocols for CT surveillance, and adherence to use of low radiation dose techniques. |
| Numbers of imaging tests, biopsy tests and surgical procedures, measured by review of electronic health records | Measured from date of nodule identification until date of cancer diagnosis or completion of 24 months of follow-up | Compare resource utilization. |
Countries
United States
Outcome results
None listed