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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
34,686
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)
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.
Kaiser Permanente Southern California
Pasadena, California, United States
Proportion of cancerous nodules with tumor (T) stage greater than T1a disease by the AJCC staging system, 7th edition
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.
Time frame: 24 months after enrollment
Number of days from date of nodule identification to date of cancer diagnosis
Ongoing, final analysis in year 5
Time frame: Up to 2 years
Survival time from date of cancer diagnosis until death or end of study
Ongoing, final analysis in year 5
Time frame: Up to 4 years
Emotional distress, measured with the Impact of Events Scale
Compare patient-reported emotional distress
Time frame: Measured at 2 months, 13 months, and 25 months following nodule identification
Anxiety, measured with the State Anxiety Inventory, 6-item
Compare patient-reported anxiety
Time frame: Measured at 2 months, 13 months, and 25 months following nodule identification
General health status, measured with a single question
Compare patient-reported general health status
Time frame: Measured at 2 months, 13 months, and 25 months following nodule identification
Numbers of imaging tests, biopsy tests and surgical procedures, measured by review of electronic health records
Compare resource utilization.
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Time frame: Measured from date of nodule identification until date of cancer diagnosis or completion of 24 months of follow-up
Exposure to ionizing radiation, using the computed tomography dose index (CTDIvol), measured in mGy (milliGray)
Compare effective radiation doses received.
Time frame: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
Exposure to ionizing radiation, using the the dose length product (DLP), measured in mGy*cm
Compare effective radiation doses received.
Time frame: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
Numbers of CT scans recommended by the assigned protocol that were not ordered by the ordering provider, and/or not completed by the patient
Compare adherence to the recommended protocols for CT surveillance, and adherence to use of low radiation dose techniques.
Time frame: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up