Integrating tobacco treatment into cancer care: Study protocol for a randomized controlled comparative effectiveness trial

Abstract

Background Despite the well-established risks of persistent smoking, 10-30% of cancer patients continue to smoke after diagnosis. Evidence based tobacco treatment has yet to be integrated into routine oncology care. This paper describes the protocol, manualized treatment, evaluation plan, and overall study design of comparing the effectiveness and cost of two treatments across two major cancer centers. Methods/Design A two-arm, two-site randomized controlled comparative effectiveness trial is testing the hypothesis that an Intensive Treatment (IT) intervention is more effective than a Standard Treatment (ST) intervention in helping recently diagnosed cancer patients quit smoking. Both interventions include 4 weekly counseling sessions and FDA-approved smoking cessation medication advice. The IT includes an additional 4 biweekly and 3 monthly booster sessions as well as dispensal of the recommended FDA-approved smoking cessation medication at no cost. The trial is enrolling patients with suspected or newly diagnosed cancer who have smoked a cigarette in the past 30 days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6 months. The primary study outcome is 7-day point prevalence biochemically-validated tobacco abstinence. Secondary study outcomes include the incremental cost-effectiveness of the IT vs. ST. Discussion This trial will answer key questions about delivering tobacco treatment interventions to newly diagnosed cancer patients. If found to be efficacious and cost-effective, this treatment will serve as a model to be integrated into oncology care settings nation-wide, as we strive to improve treatment outcomes and quality of life for cancer patients.

Patient-Level Factors Associated with Oncology Provider-Delivered Brief Tobacco Treatment Among Recently Diagnosed Cancer Patients

“…When possible, study visits were conducted in conjunction with patients' existing oncology visits in order to minimize participant burden. Detailed protocol methods and eligibility criteria have been published previously (Park et al, 2016). 11 This research was approved by the institutional review boards at each participating site.…”

“…Detailed protocol methods and eligibility criteria have been published previously (Park et al, 2016). 11 This research was approved by the institutional review boards at each participating site.…”

Electronic cigarette use patterns and reasons for use among smokers recently diagnosed with cancer

“…We conducted a secondary cross‐sectional analysis of baseline enrollment data from the Smokefree Support Study, a multi‐site, randomized controlled comparative effectiveness trial of tobacco treatment interventions in smokers with recent diagnosis of various tobacco and nontobacco‐related cancers. The trial protocol has been described previously . Enrollment took place from November 2013 through June 2017.…”

“…Recruitment occurred from two academic medical centers: Partners Healthcare (Massachusetts General Hospital and Dana Farber Cancer Institute, Boston, MA) and Memorial Sloan Kettering Cancer Center (New York, NY). Other inclusion and exclusion criteria were described previously …”

Associated factors with health-compromising behaviors among patients treated for oral cancer

“…It may be attributable to the lesser awareness of the severity of their disease, the receipt of less radical treatment, the greater expectation of survival, and/or less concern about the possibility of recurrence over time. Taking into account these results and the evidenced efficacy and cost-effectiveness of tobacco treatment into cancer care (23), preventive health education integrating the alcohol issue should be continued over time in oral cancer patients.…”