Effect of Sustained Smoking Cessation Counseling and Provision of Medication vs Shorter-term Counseling and Medication Advice on Smoking Abstinence in Patients Recently Diagnosed With CancerA Randomized Clinical Trial

Corresponding Author: Elyse R. Park, PhD, MPH, Health Policy Research Center, Mongan Institute, Massachusetts Hospital and Harvard Medical School, 100 Cambridge St, Ste 1600, Boston, MA 02114 (epark@mgh.harvard.edu).

Accepted for Publication: July 21, 2020.

Author Contributions: Dr Park had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Park, Muzikansky, Temel, Rigotti, Irwin, Hyland, Gonzalez, Whitlock, Malloy, de León-Sanchez, O’Brien, Ostroff.

Acquisition, analysis, or interpretation of data: Park, Perez, Regan, Muzikansky, Levy, Temel, Rigotti, Pirl, Irwin, Partridge, Cooley, Friedman, Rabin, Ponzani, Hyland, Holland, Borderud, Sprunck, Kwon, Peterson, Miller-Sobel, O’Brien, Ostroff.

Drafting of the manuscript: Park, Perez, Muzikansky, Temel, Friedman, Rabin, Ponzani, Borderud, Peterson, Miller-Sobel, Whitlock, Malloy, de León-Sanchez, O’Brien, Ostroff.

Critical revision of the manuscript for important intellectual content: Park, Perez, Regan, Muzikansky, Levy, Temel, Rigotti, Pirl, Irwin, Partridge, Cooley, Hyland, Holland, Sprunck, Kwon, Gonzalez, Whitlock, Ostroff.

Statistical analysis: Park, Regan, Muzikansky, Friedman, Rabin, O’Brien.

Obtained funding: Park, O’Brien, Ostroff.

Administrative, technical, or material support: Pirl, Cooley, Friedman, Rabin, Ponzani, Hyland, Borderud, Sprunck, Kwon, Peterson, Miller-Sobel, Gonzalez, Whitlock, Malloy, O’Brien, Ostroff.

Supervision: Park, Perez, Rigotti, Partridge, Borderud, Gonzalez, Whitlock, O’Brien, Ostroff.

Conflict of Interest Disclosures: Dr Park reported receiving a grant from Pfizer to support provision of varenicline for this study as well as grants from Pfizer outside the submitted work and royalties provided for a chapter, “Behavioral approaches for smoking cessation,” from UpToDate. Dr Levy reported receiving grants from the National Institutes of Health during the conduct of the study. Dr Temel reported receiving grants from Pfizer outside the submitted work. Dr Rigotti reported receiving grants from the National Cancer Institute during the conduct of the study and personal fees from UpToDate and Achieve Life Sciences outside the submitted work; and reported that Pfizer paid travel expenses but no personal fees for attendance at advisory committee meetings. Dr Pirl reported receiving financial support from Wiley for editorial services. Dr Irwin reported receiving grants from the National Institutes of Health/National Cancer Institute during the conduct of the study. Dr Cooley reported receiving grants from the National Cancer Institute during the conduct of the study. Dr Ostroff reported receiving royalties from UpToDate, an in-kind donation of nicotine replacement therapy from the CVS Foundation, and personal fees from ACS outside the submitted work. No other disclosures were reported.

Funding/Support: This research study was funded by the National Cancer Institute (grants 5 R01 CA166147-05 and 1 K24 CA197382) and Pfizer (grant Investigator-Initiated Research WS581690).

Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 3.

Additional Contributions: We thank study consultants Robert Schnoll, PhD, University of Pennsylvania, Adam Goldstein, MD, MPH, University of North Carolina School of Medicine, Mary Ellen Wewers, PhD, MPH, The Ohio State University College of Public Health, and Carolyn Dresler, MD, MPA, Action on Smoking and Health. Drs Schnoll, Goldstein, and Wewers received compensation for their consultation on this study. We thank data and safety monitoring board members Donna Greenberg, MD (chair), Michael Lanuti, MD, Amy Comander, MD, Jonathan Winickoff, MD, MPH, and Hui Zheng, PhD. Dr Lanuti received compensation for his role on the data and safety monitoring board for this study. We express our gratitude for the oncology clinic liaisons at Massachusetts General Hospital: Jennifer Temel, MD, Michael Lanuti, MD, Beverly Moy, MD, Lori Wirth, MD, Philip Saylor, MD, Dave Ryan, MD, Donald Lawrence, MD, Jeremy Abramson, MD, and Richard Penson, MD. They did not receive compensation for their support of this study.