title: Integrating tobacco treatment into cancer care: Study protocol for a randomized controlled comparative effectiveness trial.
abstract: 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.
  
  
  
  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 30days. Participants are randomly assigned to receive the ST or IT condition. Tobacco cessation outcomes are assessed at 3 and 6months. 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.
  
  
  
  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.
authors.affiliation: Mongan Institute for Health Policy, Massachusetts General Hospital, Boston, MA, United States; Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, United States; Cancer Outcomes Research Program, Massachusetts General Hospital, Boston, MA, United States; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States; Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, Boston, MA, United States; Department of Medicine, Harvard Medical School, Boston, MA, United States. Electronic address: epark@mgh.harvard.edu.
authors.forename: Elyse R
authors.initials: ER
authors.lastname: Park
authors.affiliation: Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, NY, United States. Electronic address: ostroffj@mskcc.org.
authors.forename: Jamie S
authors.initials: JS
authors.lastname: Ostroff
authors.affiliation: Mongan Institute for Health Policy, Massachusetts General Hospital, Boston, MA, United States; Cancer Outcomes Research Program, Massachusetts General Hospital, Boston, MA, United States; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States. Electronic address: gperez@mgh.harvard.edu.
authors.forename: Giselle K
authors.initials: GK
authors.lastname: Perez
authors.affiliation: H. Lee Moffitt Cancer Center and Research Institute, University of South Florida, Tampa, FL, United States. Electronic address: khyland@mail.usf.edu.
authors.forename: Kelly A
authors.initials: KA
authors.lastname: Hyland
authors.affiliation: Mongan Institute for Health Policy, Massachusetts General Hospital, Boston, MA, United States; Tobacco Research and Treatment Center, Massachusetts General Hospital, Boston, MA, United States; Department of Medicine, Harvard Medical School, Boston, MA, United States. Electronic address: nrigotti@partners.org.
authors.forename: Nancy A
authors.initials: NA
authors.lastname: Rigotti
authors.affiliation: Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, NY, United States. Electronic address: borderus@mskcc.org.
authors.forename: Sarah
authors.initials: S
authors.lastname: Borderud
authors.affiliation: Mongan Institute for Health Policy, Massachusetts General Hospital, Boston, MA, United States. Electronic address: sregan@mgh.harvard.edu.
authors.forename: Susan
authors.initials: S
authors.lastname: Regan
authors.affiliation: Biostatistics Center, Massachusetts General Hospital, Boston, MA, United States. Electronic address: amuzikansky@mgh.harvard.edu.
authors.forename: Alona
authors.initials: A
authors.lastname: Muzikansky
authors.affiliation: Mongan Institute for Health Policy, Massachusetts General Hospital, Boston, MA, United States; Cancer Outcomes Research Program, Massachusetts General Hospital, Boston, MA, United States. Electronic address: erfriedman@mgh.harvard.edu.
authors.forename: Emily R
authors.initials: ER
authors.lastname: Friedman
authors.affiliation: Mongan Institute for Health Policy, Massachusetts General Hospital, Boston, MA, United States. Electronic address: dlevy3@mgh.harvard.edu.
authors.forename: Douglas E
authors.initials: DE
authors.lastname: Levy
authors.affiliation: Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, NY, United States. Electronic address: hollands@mskcc.org.
authors.forename: Susan
authors.initials: S
authors.lastname: Holland
authors.affiliation: Cancer Outcomes Research Program, Massachusetts General Hospital, Boston, MA, United States. Electronic address: jeusebio@mgh.harvard.edu.
authors.forename: Justin
authors.initials: J
authors.lastname: Eusebio
authors.affiliation: Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, NY, United States. Electronic address: petersol@mskcc.org.
authors.forename: Lisa
authors.initials: L
authors.lastname: Peterson
authors.affiliation: Mongan Institute for Health Policy, Massachusetts General Hospital, Boston, MA, United States; Cancer Outcomes Research Program, Massachusetts General Hospital, Boston, MA, United States. Electronic address: jtrabin@mgh.harvard.edu.
authors.forename: Julia
authors.initials: J
authors.lastname: Rabin
authors.affiliation: Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, NY, United States. Electronic address: millersj@mskcc.org.
authors.forename: Jacob
authors.initials: J
authors.lastname: Miller-Sobel
authors.affiliation: Department of Psychiatry, Massachusetts General Hospital, Boston, MA, United States. Electronic address: igonzalez4@mgh.harvard.edu.
authors.forename: Irina
authors.initials: I
authors.lastname: Gonzalez
authors.affiliation: Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, Boston, MA, United States. Electronic address: lmalloy@mgh.harvard.edu.
authors.forename: Laura
authors.initials: L
authors.lastname: Malloy
authors.affiliation: Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, NY, United States. Electronic address: obrienm@mskcc.org.
authors.forename: Maureen
authors.initials: M
authors.lastname: O'Brien
authors.affiliation: Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, NY, United States. Electronic address: deleonss@mskcc.org.
authors.forename: Suhana
authors.initials: S
authors.lastname: de León-Sanchez
authors.affiliation: Department of Psychiatry & Behavioral Sciences, Tobacco Treatment Program, Memorial Sloan Kettering Cancer Center, New York, NY, United States. Electronic address: whitlocc@mskcc.org.
authors.forename: C Will
authors.initials: CW
authors.lastname: Whitlock
mesh_terms: D002173:Cancer Care Facilities / Q000458:organization & administration*; D057186:Comparative Effectiveness Research; D003362:Cost-Benefit Analysis; D003376:Counseling / Q000379:methods*; D004644:Emotions; D004777:Environment; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000453:epidemiology*; D011788:Quality of Life; D012107:Research Design; D016540:Smoking Cessation / Q000191:economics / Q000379:methods*; D012959:Socioeconomic Factors; D061485:Tobacco Use Cessation Devices
keywords: Cancer patients; Motivational interviewing; Pharmacotherapy; Randomized controlled trial; Smoking cessation; Tobacco treatment