The current study is, to our knowledge, the first controlled study of a combined behavioral and pharmacological tobacco treatment program targeting patients at their entry into thoracic surgery and thoracic oncology clinics. We found that the program was feasible and acceptable. Furthermore, the intervention produced higher biochemically-validated smoking cessation rates at the end of treatment, although the difference did not reach statistical significance due to the small sample size of this pilot study.
Our findings show that those who continue smoking following a lung cancer diagnosis are a challenging population with a long smoking history, high nicotine dependence, and low confidence to quit. This indicates that this particular population of smokers likely needs intensive tobacco treatment, preferably one that combines pharmacological support with extended counseling in order to achieve abstinence.
We were able to enroll almost half of eligible patients at their entry into the thoracic oncology setting, a rate similar to previous smoking cessation studies that enrolled patients following cancer treatment. 33
Enrolling as early as possible is critical because the closer to the time of diagnosis that smoking cessation treatment is delivered, the greater the health benefits, including reduced perioperative morbidity, and the higher the likelihood for continued abstinence.2, 4, 5, 32, 45
The main reasons for refusal, reluctance to take varenicline and wanting to quit unassisted, could represent quitting preferences, but these could also be proxies for not wanting to quit. Another factor to consider is that during the study enrollment period varenicline received a black box warning about psychiatric side effects, which may have caused some reluctance in smokers.46
We were able to engage patients in tobacco treatment during a vulnerable and critical period. The program length matched the USPHS recommended 90 minutes of contact time, but the number of contacts exceeded the USPHS minimum recommended number of sessions which are usually offered for telephone-delivered smoking cessation interventions.22, 24, 47
These patients seemed to need frequent, brief contacts and social support in order to promote tobacco abstinence.
Despite initial concerns that cancer patients might not tolerate varenicline due to side effects similar to cancer treatment side effects (e.g., nausea), participant adherence rates to varenicline were similar to NRT use in cancer patients and non-cancer patients. 48, 49
Similar to varenicline in the general population, nausea was the most common side effect, reported in one-third of participants.
This study had several limitations. The generalizability of the findings was limited by using only a single study site. The statistical power to detect differences was limited by the small sample size of this pilot study. Although the sample size cannot be increased in accordance to power calculations that would enable detection of a statistically significant difference, we believe the encouraging non-statistical trend provides a rationale for an adequately powered RCT. Its non-randomized design leaves open the potential for unmeasured confounding to effect results due to group dissimilarities.
Despite these limitations, our combined behavioral and varenicline intervention produced promising feasibility and potential efficacy results. In pursuit of a larger scale randomized trial to assess the efficacy of our counseling plus varenicline treatment, we recommend comparison of two treatment arms: an “intensive” counseling plus varenicline versus a “brief” counseling plus varenicline. A counseling only or varenicline only comparison group would not be in compliance with clinical practice guidelines. Additionally, a counseling only comparison would not build on this work which supported the tolerability of varenicline in this population, and, given the psychological and medical vulnerability of this population, it is not preferable to use a varenicline only comparison.