Lung Cancer Screening Offers Opportunity for Tobacco Cessation Trial Enrollment: Efren Flores, MD

Several sociodemographic and health care–related factors that have been linked with lower clinical trial participation in past studies were associated with higher likelihood of enrollment in a subanalysis of the Screen ASSIST tobacco cessation clinical trial (NCT03611881). The findings, which are being presented at the 2025 World Conference on Lung Cancer, suggest a key opportunity to improve diversity in clinical trial participation and mitigate disparities in lung cancer and other smoking-related disease outcomes.

Study author Efren Flores, MD, associate professor at Harvard Medical School, radiologist at Massachusetts General Hospital, and vice chair of faculty and trainee enrichment at Mass General Brigham Radiology, discussed the study’s findings in an interview with The American Journal of Managed Care^®.

This transcript has been lightly edited for clarity; captions were= auto-generated.

Transcript

What were the main findings of the study, and how do they align with previous studies examining tobacco cessation clinical trial participation?

I think the main finding—when we were doing this study as a subset analysis for a larger clinical trial called Screen ASSIST, which integrated tobacco cessation into lung cancer screening with 3 different recruitment points: at the time of ordering lung cancer screening, at the time of getting lung cancer screenings with low-dose CT, and after the lung cancer screening results were finalized and shared with the physician and the patien—the main purpose of that clinical trial was getting patients who were currently smoking and undergoing lung screening to quit through a combination of tobacco cessation counseling and nicotine replacement therapy, plus connecting them with local resources depending on their screening for social determinants of health.

The main purpose of this subset analysis of the larger clinical trial was to assess the association of different sociodemographic and health care factors and the association between that and enrollment in this tobacco cessation randomized clinical trial called Screen ASSIST. That was the main purpose of the study.

The main finding that we found with the results is that although we have relatively low enrollment—around 15%, less than 20% of the patients whod were eligible—because over 4000 patients were eligible for this study, but 15.7% enrolled, which will be in line with typical clinical trials for tobacco cessation, given the stigma associated with smoking and everything, but lower than other clinical trials. We found that, interestingly, there were higher enrollment rates among women; non-Hispanic Black patients, a racial/ethnic minority population; people with no primary care visits over the past year; and then college graduates.

What we thought was interesting was that people with no primary care visits would have a higher likelihood or higher proportional enrollment in the clinical trial, which would be somewhat counterintuitive, because primary care visits tend to be a point where people get recruited and participate in clinical trials. But it shows that people are still engaged with lung cancer screening, so they're still undergoing cancer screening, and we can leverage those encounters—not only to recruit for clinical trials, but frankly, to promote overall better health; in this case, through tobacco cessation. And then logistic regression analysis showed higher likelihood of enrollment among people who were 70 years or older, women, and non-Hispanic Black again. Tdhe univariate analysis and some of the results that we saw there were also consistent with the logistic regression analysis—college graduates and those with no primary care visits. We looked at other factors, such as area deprivation index, or ADI, as a measure of socioeconomic status, but there was no significant association that we saw on the results, among others.

Your results showed higher enrollment among groups often underrepresented in clinical trials. What do you think drove this reversal of typical patterns?

I think that there are several factors, and that's a great question. One of them is related to offering the recruitment at different time points. We were able to offer it at the time when they were seeing the doctor and ordering the lung screening CT, when the patient was coming in for the CT, and then after the patient had the lung cancer screening CT results. It gives patients a little bit more time to ponder about the opportunity as well. It gives them flexibility and time to consider participation, and that's number 1.

Number 2 is the opportunity to do this tobacco cessation counseling and get their resources remotely. There was no requirement for them to come in in person. Everything was offered remotely, at the convenience of their time and in the convenience of their home, or whatever they felt more comfortable with. I think that really helped with offering flexibility and participation. Leveraging telehealth or telemedicine for the counseling component, offering different time points, and then also integrating it into a clinical pathway. Patients already went through the process of thinking about, "Okay, I'm eligible for lung screening," and decided to undergo lung screening. It becomes almost like a teachable moment, a moment that you want to leverage to advance other things. Can we engage them also—if you're smoking currently, if you're thinking about cancer screening or early lung cancer detection, can we also leverage that moment to help patients or participants quit smoking as well so they can get the bigger benefit from tobacco cessation and everything that comes from quitting cigarette smoking?

Reference

Presented at: 2025 World Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain. Abstract OA18.04.