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The Watch the Spot Trial (WTS)

Primary Purpose

Solitary Pulmonary Nodule, Coin Lesion, Pulmonary, Lung Neoplasms

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
More Frequent Surveillance Strategy
Less Frequent Surveillance Strategy
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Solitary Pulmonary Nodule

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

More Frequent CT Surveillance

Less Frequent CT Surveillance

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of days from date of nodule identification to date of cancer diagnosis
Ongoing, final analysis in year 5
Survival time from date of cancer diagnosis until death or end of study
Ongoing, final analysis in year 5
Emotional distress, measured with the Impact of Events Scale
Compare patient-reported emotional distress
Anxiety, measured with the State Anxiety Inventory, 6-item
Compare patient-reported anxiety
General health status, measured with a single question
Compare patient-reported general health status
Numbers of imaging tests, biopsy tests and surgical procedures, measured by review of electronic health records
Compare resource utilization.
Exposure to ionizing radiation, using the computed tomography dose index (CTDIvol), measured in mGy (milliGray)
Compare effective radiation doses received.
Exposure to ionizing radiation, using the the dose length product (DLP), measured in mGy*cm
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
Compare adherence to the recommended protocols for CT surveillance, and adherence to use of low radiation dose techniques.

Full Information

First Posted
December 1, 2015
Last Updated
May 25, 2023
Sponsor
Kaiser Permanente
Collaborators
Patient-Centered Outcomes Research Institute, University of California, Davis, University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02623712
Brief Title
The Watch the Spot Trial
Acronym
WTS
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 6, 2017 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaiser Permanente
Collaborators
Patient-Centered Outcomes Research Institute, University of California, Davis, University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solitary Pulmonary Nodule, Coin Lesion, Pulmonary, Lung Neoplasms, Carcinoma, Non-small-cell Lung

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
More Frequent CT Surveillance
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Less Frequent CT Surveillance
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
More Frequent Surveillance Strategy
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Less Frequent Surveillance Strategy
Intervention Description
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 Measure Information:
Title
Proportion of cancerous nodules with tumor (T) stage greater than T1a disease by the AJCC staging system, 7th edition
Description
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
Secondary Outcome Measure Information:
Title
Number of days from date of nodule identification to date of cancer diagnosis
Description
Ongoing, final analysis in year 5
Time Frame
Up to 2 years
Title
Survival time from date of cancer diagnosis until death or end of study
Description
Ongoing, final analysis in year 5
Time Frame
Up to 4 years
Title
Emotional distress, measured with the Impact of Events Scale
Description
Compare patient-reported emotional distress
Time Frame
Measured at 2 months, 13 months, and 25 months following nodule identification
Title
Anxiety, measured with the State Anxiety Inventory, 6-item
Description
Compare patient-reported anxiety
Time Frame
Measured at 2 months, 13 months, and 25 months following nodule identification
Title
General health status, measured with a single question
Description
Compare patient-reported general health status
Time Frame
Measured at 2 months, 13 months, and 25 months following nodule identification
Title
Numbers of imaging tests, biopsy tests and surgical procedures, measured by review of electronic health records
Description
Compare resource utilization.
Time Frame
Measured from date of nodule identification until date of cancer diagnosis or completion of 24 months of follow-up
Title
Exposure to ionizing radiation, using the computed tomography dose index (CTDIvol), measured in mGy (milliGray)
Description
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
Title
Exposure to ionizing radiation, using the the dose length product (DLP), measured in mGy*cm
Description
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
Title
Numbers of CT scans recommended by the assigned protocol that were not ordered by the ordering provider, and/or not completed by the patient
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael K Gould, MD, MS
Organizational Affiliation
Kaiser Permanente School of Medicin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Southern California
City
Pasadena
State/Province
California
ZIP/Postal Code
91011
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing 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.
IPD Sharing 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.
Citations:
PubMed Identifier
16244247
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.
Results Reference
background
PubMed Identifier
23070270
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.
Results Reference
background
PubMed Identifier
23649456
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.
Results Reference
background
PubMed Identifier
20008689
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.
Results Reference
background
PubMed Identifier
20573919
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.
Results Reference
background
PubMed Identifier
22692172
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.
Results Reference
background
PubMed Identifier
26214244
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.
Results Reference
background
PubMed Identifier
24710850
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.
Results Reference
background
PubMed Identifier
18046031
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.
Results Reference
background
PubMed Identifier
12815140
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.
Results Reference
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The Watch the Spot Trial

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