The Watch the Spot Trial (WTS)

• ClinicalTrials.gov Identifier: NCT02623712
• Recruitment Status: Active, not recruiting
• First Posted: December 8, 2015
• Last Update Posted: April 19, 2024
• Sponsor: Kaiser Permanente
• Collaborators: Patient-Centered Outcomes Research Institute; University of California, Davis; University of California, San Francisco
• Information provided by (Responsible Party): Michael K Gould, MD, Kaiser Permanente

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Solitary Pulmonary Nodule; Coin Lesion, Pulmonary; Lung Neoplasms; Carcinoma, Non-small-cell Lung	Other: More Frequent Surveillance Strategy; Other: Less Frequent Surveillance Strategy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 35200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: The Watch the Spot Trial: A Pragmatic Trial of More Versus Less Intensive Strategies for Active Surveillance of Patients With Small Pulmonary Nodules
• Actual Study Start Date: March 6, 2017
• Estimated Primary Completion Date: July 31, 2024
• Estimated Study Completion Date: July 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: More Frequent CT Surveillance; 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; 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)
Active Comparator: Less Frequent CT Surveillance; 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; 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.

Outcome Measures

Primary Outcome Measures :

1. Proportion of cancerous nodules with tumor (T) stage greater than T1a disease by the AJCC staging system, 7th edition [ Time Frame: 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 :

1. Number of days from date of nodule identification to date of cancer diagnosis [ Time Frame: Up to 2 years ]
   Ongoing, final analysis in year 5
2. Survival time from date of cancer diagnosis until death or end of study [ Time Frame: Up to 4 years ]
   Ongoing, final analysis in year 5
3. Emotional distress, measured with the Impact of Events Scale [ Time Frame: Measured at 2 months, 13 months, and 25 months following nodule identification ]
   Compare patient-reported emotional distress
4. Anxiety, measured with the State Anxiety Inventory, 6-item [ Time Frame: Measured at 2 months, 13 months, and 25 months following nodule identification ]
   Compare patient-reported anxiety
5. General health status, measured with a single question [ Time Frame: Measured at 2 months, 13 months, and 25 months following nodule identification ]
   Compare patient-reported general health status
6. Numbers of imaging tests, biopsy tests and surgical procedures, measured by review of electronic health records [ Time Frame: Measured from date of nodule identification until date of cancer diagnosis or completion of 24 months of follow-up ]
   Compare resource utilization.
7. Exposure to ionizing radiation, using the computed tomography dose index (CTDIvol), measured in mGy (milliGray) [ Time Frame: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up ]
   Compare effective radiation doses received.
8. Exposure to ionizing radiation, using the the dose length product (DLP), measured in mGy*cm [ Time Frame: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up ]
   Compare effective radiation doses received.
9. Numbers of CT scans recommended by the assigned protocol that were not ordered by the ordering provider, and/or not completed by the patient [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 35 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Kaiser Permanente Southern California

Pasadena, California, United States, 91011

Sponsors and Collaborators

Kaiser Permanente

Patient-Centered Outcomes Research Institute

University of California, Davis

University of California, San Francisco

Investigators

• Principal Investigator: Michael K Gould, MD, MS; Kaiser Permanente School of Medicin

  Study Documents (Full-Text)

Documents provided by Michael K Gould, MD, Kaiser Permanente:

Study Protocol and Statistical Analysis Plan  [PDF] November 14, 2022

More Information

Publications:

MacMahon H, Austin JH, Gamsu G, Herold CJ, Jett JR, Naidich DP, Patz EF Jr, Swensen SJ; Fleischner Society. Guidelines for management of small pulmonary nodules detected on CT scans: a statement from the Fleischner Society. Radiology. 2005 Nov;237(2):395-400. doi: 10.1148/radiol.2372041887.

Naidich DP, Bankier AA, MacMahon H, Schaefer-Prokop CM, Pistolesi M, Goo JM, Macchiarini P, Crapo JD, Herold CJ, Austin JH, Travis WD. Recommendations for the management of subsolid pulmonary nodules detected at CT: a statement from the Fleischner Society. Radiology. 2013 Jan;266(1):304-17. doi: 10.1148/radiol.12120628. Epub 2012 Oct 15.

Gould MK, Donington J, Lynch WR, Mazzone PJ, Midthun DE, Naidich DP, Wiener RS. Evaluation of individuals with pulmonary nodules: when is it lung cancer? Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e93S-e120S. doi: 10.1378/chest.12-2351.

Berrington de Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009 Dec 14;169(22):2071-7. doi: 10.1001/archinternmed.2009.440.

Smith-Bindman R. Is computed tomography safe? N Engl J Med. 2010 Jul 1;363(1):1-4. doi: 10.1056/NEJMp1002530. Epub 2010 Jun 23. No abstract available.

Smith-Bindman R, Miglioretti DL, Johnson E, Lee C, Feigelson HS, Flynn M, Greenlee RT, Kruger RL, Hornbrook MC, Roblin D, Solberg LI, Vanneman N, Weinmann S, Williams AE. Use of diagnostic imaging studies and associated radiation exposure for patients enrolled in large integrated health care systems, 1996-2010. JAMA. 2012 Jun 13;307(22):2400-9. doi: 10.1001/jama.2012.5960.

Gould MK, Tang T, Liu IL, Lee J, Zheng C, Danforth KN, Kosco AE, Di Fiore JL, Suh DE. Recent Trends in the Identification of Incidental Pulmonary Nodules. Am J Respir Crit Care Med. 2015 Nov 15;192(10):1208-14. doi: 10.1164/rccm.201505-0990OC.

Wiener RS, Gould MK, Slatore CG, Fincke BG, Schwartz LM, Woloshin S. Resource use and guideline concordance in evaluation of pulmonary nodules for cancer: too much and too little care. JAMA Intern Med. 2014 Jun;174(6):871-80. doi: 10.1001/jamainternmed.2014.561.

Brenner DJ, Hall EJ. Computed tomography--an increasing source of radiation exposure. N Engl J Med. 2007 Nov 29;357(22):2277-84. doi: 10.1056/NEJMra072149. No abstract available.

Ost D, Fein AM, Feinsilver SH. Clinical practice. The solitary pulmonary nodule. N Engl J Med. 2003 Jun 19;348(25):2535-42. doi: 10.1056/NEJMcp012290. No abstract available.

• Responsible Party: Michael K Gould, MD, Director for Health Services Research and Implementation Science, Kaiser Permanente
• ClinicalTrials.gov Identifier: NCT02623712
• Other Study ID Numbers: 1000001
• First Posted: December 8, 2015
• Last Update Posted: April 19, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: We plan to share de-identified IPD for all study variables with other researchers on request as long as there is an acceptable justification
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• Time Frame: De-identified IPD will be made available within 6-12 months following study completion, to allow time for the primary study team to complete manuscripts that report on each of the 4 study aims.
• Access Criteria: Interested researchers will be required to submit a formal request with justification and aims to the study Data Coordinating Center. Requests will be reviewed and approved by the study Executive Committee. Relevant data use or data transfer agreements will need to be completed.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Multiple Pulmonary Nodules; Solitary Pulmonary Nodule; Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases