The Watch the Spot Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Watch the Spot Trial: A Pragmatic Trial of More Versus Less Intensive Strategies for Active Surveillance of Patients With Small Pulmonary Nodules

Conditions
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Solitary Pulmonary Nodule, Coin Lesion, Pulmonary, Lung Neoplasms, Carcinoma, Non-small-cell Lung

Intervention / Treatment
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* Other: More Frequent Surveillance Strategy
* Other: Less Frequent Surveillance Strategy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: More Frequent CT Surveillance<br>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) | Other: More Frequent Surveillance Strategy<br>* 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)<br>|
| Active Comparator: Less Frequent CT Surveillance<br>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. | Other: Less Frequent Surveillance Strategy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days from date of nodule identification to date of cancer diagnosis | Ongoing, final analysis in year 5 | Up to 2 years | 
| Survival time from date of cancer diagnosis until death or end of study | Ongoing, final analysis in year 5 | Up to 4 years | 
| Emotional distress, measured with the Impact of Events Scale | Compare patient-reported emotional distress | 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 | 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 | 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. | 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. | 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. | 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. | Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up |