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How effective is sustained cessation telephone counseling plus medication treatment compared with shorter-term telephone counseling plus medication advice for smokers recently diagnosed with cancer?
In this randomized clinical trial of 303 patients, conducted at 2 National Cancer Institute–designated Comprehensive Cancer Centers, sustained telephone counseling over 6 months and provision of free medication compared with 4-week telephone counseling and medication advice resulted in 6-month biochemically confirmed quit rates of 34.5% vs 21.5%, a difference that was statistically significant.
Among patients recently diagnosed with cancer, sustained cessation counseling and free medication may increase the likelihood of smoking abstinence compared with shorter-term counseling, but the generalizability of the study findings is uncertain and requires further research.
Persistent smoking may cause adverse outcomes among patients with cancer. Many cancer centers have not fully implemented evidence-based tobacco treatment into routine care.
To determine the effectiveness of sustained telephone counseling and medication (intensive treatment) compared with shorter-term telephone counseling and medication advice (standard treatment) to assist patients recently diagnosed with cancer to quit smoking.
Design, Setting, and Participants
This unblinded randomized clinical trial was conducted at Massachusetts General Hospital/Dana-Farber/Harvard Cancer Center and Memorial Sloan Kettering Cancer Center. Adults who had smoked 1 cigarette or more within 30 days, spoke English or Spanish, and had recently diagnosed breast, gastrointestinal, genitourinary, gynecological, head and neck, lung, lymphoma, or melanoma cancers were eligible. Enrollment occurred between November 2013 and July 2017; assessments were completed by the end of February 2018.
Participants randomized to the intensive treatment (n = 153) and the standard treatment (n = 150) received 4 weekly telephone counseling sessions and medication advice. The intensive treatment group also received 4 biweekly and 3 monthly telephone counseling sessions and choice of Food and Drug Administration–approved cessation medication (nicotine replacement therapy, bupropion, or varenicline).
Main Outcome and Measures
The primary outcome was biochemically confirmed 7-day point prevalence tobacco abstinence at 6-month follow-up. Secondary outcomes were treatment utilization rates.
Among 303 patients who were randomized (mean age, 58.3 years; 170 women [56.1%]), 221 (78.1%) completed the trial. Six-month biochemically confirmed quit rates were 34.5% (n = 51 in the intensive treatment group) vs 21.5% (n = 29 in the standard treatment group) (difference, 13.0% [95% CI, 3.0%-23.3%]; odds ratio, 1.92 [95% CI, 1.13-3.27]; P < .02). The median number of counseling sessions completed was 8 (interquartile range, 4-11) in the intensive treatment group. A total of 97 intensive treatment participants (77.0%) vs 68 standard treatment participants (59.1%) reported cessation medication use (difference, 17.9% [95% CI, 6.3%-29.5%]; odds ratio, 2.31 [95% CI, 1.32-4.04]; P = .003). The most common adverse events in the intensive treatment and standard treatment groups, respectively, were nausea (n = 13 and n = 6), rash (n = 4 and n = 1), hiccups (n = 4 and n = 1), mouth irritation (n = 4 and n = 0), difficulty sleeping (n = 3 and n = 2), and vivid dreams (n = 3 and n = 2).
Conclusions and Relevance
Among smokers recently diagnosed with cancer in 2 National Cancer Institute–designated Comprehensive Cancer Centers, sustained counseling and provision of free cessation medication compared with 4-week counseling and medication advice resulted in higher 6-month biochemically confirmed quit rates. However, the generalizability of the study findings is uncertain and requires further research.
ClinicalTrials.gov Identifier: NCT01871506
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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 (firstname.lastname@example.org).
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.
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