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Pragmatic trial of more versus less intensive strategies for active surveillance of patients with small pulmonary nodules
Investigator (PI): Gould, Michael K
Performing Organization (PO): (Current): Kaiser Permanente Research, Department of Research & Evaluation / (626) 564-3455
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2015
Final Year: 2024
Record Source/Award ID: PCORI/PCS-1403-12653
Funding: Total Award Amount: $14,424,951
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Background: Guidelines now recommend that smokers and former smokers undergo lung cancer screening, which can identify small growths. These pulmonary nodules are typically then monitored with serial CT scans that look for changes suggesting the nodules are cancerous. However, the optimal frequency of such scans has not been determined. The proposed research will compare more intensive versus less intensive protocols for CT surveillance. Objectives: Among individuals with small pulmonary nodules that progress beyond the most curable stage of lung cancer, we will compare two protocols for CT surveillance, both of which are supported by existing guidelines from professional societies and are consistent with current standards of care. We consider patient-reported outcomes of emotional distress, anxiety, general health status, and satisfaction with the evaluation process; resource utilization and exposure to diagnostic radiation; adherence to the recommended protocols for surveillance; and adherence to use of low-radiation-dose techniques. Methods: Using automated methods for identification, notification, and registration into the study, we will enroll eligible patients at each of 26 hospitals within 14 health care systems. We estimate that almost 47,000 patients will be passively enrolled over 20 months and followed for two years. We will perform analyses to determine which protocol works best for specific subgroups of patients. Patient outcomes: The patient outcomes are lung cancer tumor stage T1a, the most curable stage of cancer; timeliness of lung cancer treatment; survival from lung cancer; emotional distress, anxiety, and general health status during surveillance; overall satisfaction with evaluation; number of tests and procedures performed during the surveillance period; number of procedure-related complications during the surveillance period; adherence to recommended surveillance, for both patients and providers; and exposure to potentially harmful radiation. Patient and stakeholder engagement: We have assembled a team of researchers, patients, clinicians, and stakeholders from health systems, advocacy groups, purchasers, and professional societies to help design and execute the study, and to help interpret and disseminate the results. Anticipated impact: Surveillance imaging and downstream invasive testing can be inconvenient, costly, and potentially harmful. By comparing two existing options for surveillance in the context of routine clinical practice, our trial will have a large and immediate impact on clinical care. By collaborating with stakeholders from health systems, professional societies, and advocacy groups, we will disseminate our findings widely and facilitate implementation in diverse practice settings.
MeSH Terms:
  • Clinical Trials as Topic
  • Early Detection of Cancer /*methods
  • Guideline Adherence
  • Humans
  • Image Processing, Computer-Assisted /methods
  • Lung Neoplasms /diagnosis
  • Outcome Assessment, Health Care
  • Pattern Recognition, Automated
  • Pulmonary Medicine /methods
  • Radiography, Thoracic
  • Smoking /adverse effects
  • Solitary Pulmonary Nodule /*diagnosis
  • Tomography, X-Ray Computed /methods
Country: United States
State: California
Zip Code: 91101
UI: 20153601
CTgovId: NCT02623712
Project Status: Ongoing
Record History: ('2019: Project extended to 2024\n2019: Project extended to 2023',)