Department of Research & Evaluation News

PASADENA, Calif. – The Patient-Centered Outcomes Research Institute (PCORI) recently awarded Kaiser Permanente $14.4 million to compare strategies for active surveillance of current and former smokers to scan for potentially cancerous small growths in the lungs. Current guidelines recommend that smokers and former smokers undergo lung cancer screening, which can identify these small growths (or pulmonary nodules) so they can be scanned to identify the few that are cancerous. However, the optimal frequency of such follow-up scans has not been determined. 

Beginning April 1, the five-year study will compare more intensive versus less intensive protocols for monitoring these pulmonary nodules. Michael K. Gould, MD, MS, of Kaiser Permanente Southern California is leading the study as principal investigator. 

Q: What are the expected outcomes and why is the study being done?

This study addresses a question that comes up commonly in primary care and specialty settings, which is how to best evaluate small pulmonary nodules. We estimate that over 1 million nodules are identified on chest computed tomography (CT) scans each year. Most of these nodules are harmless, but about five percent turn out to be cancer. The challenge is that it’s often difficult to distinguish the cancerous ones from the benign ones, especially with small nodules. Since these nodules are often difficult or too risky to biopsy, the default option for evaluation is to use time as a diagnostic test by doing repeat chest CT scans to check for growth. We call this active surveillance.

Relying on active surveillance then begs the question of how frequently should you have to do the surveillance? Doctors have been using active surveillance for years and several guidelines make recommendations for how frequently to repeat the CT scan, but the guidelines are based on expert opinion (not evidence) and there are currently no medical studies dedicated to determining what frequency is best. This trial will compare two options for active surveillance, both supported by existing guidelines and therefore consistent with current standards of care.

Q: What are the downsides to testing more often? Shouldn’t more testing be a good thing? 

In theory, more frequent surveillance will identify cancerous nodules sooner. However, less frequent surveillance minimizes inconvenience, anxiety, radiation exposure from CT scans, costs, false alarms and downstream complications of invasive testing among those who have false alarms.

Q: How treatable is cancer resulting from these nodules once it’s discovered? 

Once you identify the small nodules as cancerous, they are usually treatable and potentially curable. Approximately 55 or 60 percent of these cancerous lung nodules are cured. This is compared with only 5-10 percent of advanced lung cancer cases which are cured. Bottom line: these nodules are one of the only kinds of lung cancer that we can cure for all intents and purposes. 

Q: Is this the first study of its kind? 

In addition to being the first trial to compare strategies for lung nodule evaluation, this study will use a novel approach called a pragmatic trial. These trials are designed to answer questions in real practice settings, as opposed to classic, randomized trials where patients are carefully selected and interventions are delivered in an intensely controlled environment. We relax conditions in pragmatic trials so we are integrating the study as much as possible into routine clinical practice. With the exception of patients completing surveys, nothing will be different with the normal care that they would receive in a clinical practice setting.

Q: How does Kaiser Permanente’s integrated healthcare system contribute to this research? 

We will be using Kaiser Permanente’s electronic health records to identify participants and ascertain different outcomes among those patients in the trial. The whole idea here is to do trials more efficiently. 

Q: Given that the study was funded by the Patient-Centered Outcomes Research Institute, what makes this study patient-centered as compared to other studies?

We’ve assembled patients and stakeholders to participate not just as research subjects but as part of the research team. They helped to design the study and will be involved in every phase of how it is conducted. In addition, the study will measure outcomes that are important to patients such as anxiety or stress that comes up in the surveillance period, for example. These patient-centered outcomes are considered to be a distinguishing, if not unique, characteristic of studies funded by PCORI.

 Q: What benefit will the study provide for health care systems? 

The study is important to health systems because it will provide doctors and patients with better information about the tradeoffs involved in more versus less intensive surveillance and improve patient-centered care. If our hypothesis is correct that the less frequent surveillance protocol does not result in more cases of cancer progression, the study will improve affordability by showing that it is safe to do fewer CT scans.