The Watch the Spot Trial

Not Applicable

Completed

• Conditions: Lung Neoplasms; Solitary Pulmonary Nodule; Carcinoma, Non-small-cell Lung; Coin Lesion, Pulmonary
• Interventions: Other: More Frequent Surveillance Strategy; Other: Less Frequent Surveillance Strategy

• Registration Number: NCT02623712
• Lead Sponsor: Kaiser Permanente

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.

Study Timeline

• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-08
• Study Start: 2017-03-06
• Primary Completion: 2024-09-04
• Study Completion: 2024-09-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34686

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
More Frequent CT Surveillance	More 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)
Less Frequent CT Surveillance	Less 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.
Number of days from date of nodule identification to date of cancer diagnosis	Up to 2 years	Ongoing, final analysis in year 5
Survival time from date of cancer diagnosis until death or end of study	Up to 4 years	Ongoing, final analysis in year 5
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.
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.
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.

Trial Locations

Locations (1)

Kaiser Permanente Southern California; 🇺🇸 Pasadena, California, United States