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 Cancer: A Randomized Clinical Trial

Abstract

Importance: Persistent smoking may cause adverse outcomes among patients with cancer. Many cancer centers have not fully implemented evidence-based tobacco treatment into routine care.

Objective: 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.

Interventions: 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.

Results: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT01871506.

Conflict of interest statement

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.

Figures

Figure.. Flowchart of Enrollment and Intervention to Test the Effectiveness of 2 Models of Tobacco Treatment Integrated Into Cancer Care

MSK indicates Memorial Sloan Kettering Cancer Center. aPatients could give multiple reasons for refusal. The research assistant categorized the reasons patients offered according to options on the study screening tool; reasons that did not fit into 1 of these predefined categories were discussed with the team to determine fit with existing categories or establishment of new categories. bMultiple reasons for ineligibility could have been indicated on the screener. cThose who were never randomized signed a consent form but did not complete a counseling session. Reasons included participants who were not able to be reached by the study counselor, participants who withdrew citing other cancer care demands, and participants who became ineligible over time. dThose who did not complete the follow-up survey include those who could not be reached at all to complete the follow-up assessment. eFollow-up survey completion rate = completed/completed + refused + withdrew + did not complete follow-up survey. Participants who were deceased or medically ineligible (eg, in inpatient hospice or psychiatrically impaired) at follow-up were not included in the final outcome analyses (n = 5 in the intensive treatment group and n = 15 in the standard treatment group). Thus, for the intensive treatment group, the denominator is 148, and for the standard treatment group, the denominator is 135.