Clinical trial NCT02623712: The Watch the Spot Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solitary Pulmonary Nodule
Coin Lesion, Pulmonary
Lung Neoplasms
Carcinoma, Non-small-cell Lung
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: University of California, Davis
name: University of California, San Francisco
First posted: 2015-12-08
Enrollment: 34686
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Proportion of cancerous nodules with tumor (T) stage greater than T1a disease by the AJCC staging system, 7th edition
timeFrame: 24 months after enrollment
Secondary outcomes:
measure: Number of days from date of nodule identification to date of cancer diagnosis
timeFrame: Up to 2 years
measure: Survival time from date of cancer diagnosis until death or end of study
timeFrame: Up to 4 years
measure: Emotional distress, measured with the Impact of Events Scale
timeFrame: Measured at 2 months, 13 months, and 25 months following nodule identification
measure: Anxiety, measured with the State Anxiety Inventory, 6-item
timeFrame: Measured at 2 months, 13 months, and 25 months following nodule identification
measure: General health status, measured with a single question
timeFrame: Measured at 2 months, 13 months, and 25 months following nodule identification
measure: Numbers of imaging tests, biopsy tests and surgical procedures, measured by review of electronic health records
timeFrame: Measured from date of nodule identification until date of cancer diagnosis or completion of 24 months of follow-up
measure: Exposure to ionizing radiation, using the computed tomography dose index (CTDIvol), measured in mGy (milliGray)
timeFrame: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
measure: Exposure to ionizing radiation, using the the dose length product (DLP), measured in mGy*cm
timeFrame: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
measure: Numbers of CT scans recommended by the assigned protocol that were not ordered by the ordering provider, and/or not completed by the patient
timeFrame: Measured from date of nodule identification to date of cancer diagnosis or completion of 24 months of follow-up
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California
state: California
Study officials:
affiliation: Kaiser Permanente School of Medicin
name: Michael K Gould, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.