Dataset Information

Preoperative contingency management intervention for smoking abstinence in cancer patients: trial protocol for a multisite randomised controlled trial.

ABSTRACT:

Introduction

Continued smoking following a cancer diagnosis has substantial health risks including increased overall and cancer-specific mortality, risk of secondary malignancies, cancer treatment toxicity and risk of surgical complications. These risks can be mitigated by quitting smoking. The preoperative period represents a prime opportunity in which to administer robust smoking cessation treatment to both improve health and support and improve surgical outcomes. We will conduct a randomised clinical trial to evaluate the effectiveness of financial incentives delivered contingent on biochemically verified smoking abstinence (contingency management (CM)) in patients with cancer undergoing surgery.

Methods and analysis

The study will take place across two study sites, and participants (N=282) who smoke, are diagnosed with or suspected to have any type of operable cancer and have a surgical procedure scheduled in the next 10 days to 5 weeks will be randomised to receive standard care plus Monitoring Only or CM prior to surgery. All patients will receive breath carbon monoxide (CO) tests three times per week, nicotine replacement therapy and counselling. The CM group will also earn payments for self-reported smoking abstinence confirmed by CO breath test ≤4 ppm on an escalating schedule of reinforcement (with a reset if they smoked). Point prevalence abstinence (PPA) outcomes (self-report of 7-day abstinence confirmed by CO≤4 ppm and/or anabasine ≤2 ng/mL) will be assessed on the day of surgery and 6 months after surgery. The effect of CM on 7-day PPA at the time of surgery and 6-month follow-up will be modelled using generalised linear mixed effects models.

Ethics and dissemination

This study has been reviewed and approved by the Medical University of South Carolina Institutional Review Board. We will disseminate our scientific results through traditional research-oriented outlets such as presentations at scientific meetings and publications in peer-reviewed journals.

Trial registration number

NCT04605458.

SUBMITTER: Rojewski AM

PROVIDER: S-EPMC8245459 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:IntroductionThe purpose of this study was to evaluate a pilot preoperative contingency management (CM) intervention for smoking abstinence.Aims and methodsThis multisite pilot study was conducted at two cancer center-based tobacco treatment programs. Participants who were smoking, diagnosed with or suspected to have any type of operable cancer, and had a surgical procedure scheduled in the next 10 days to 5 weeks (N = 40) were randomized to receive standard care plus monitoring only (MO) or CM prior to surgery. All patients received breath carbon monoxide (CO) tests 3 times per week, nicotine patches, and counseling. The CM group also earned payments for self-reported smoking abstinence confirmed by CO breath test ≤6 ppm on an escalating schedule of reinforcement (with a reset if they smoked). Seven-day point prevalence abstinence rates on the day of surgery and at 3-month follow-up were compared between groups using repeated measures log-linear regression models utilizing generalized estimating equations. Participants lost to follow-up are assumed to have returned to smoking.ResultsThe sample was 50% female and 75% White. In covariate adjusted models, patients in the CM group had a greater probability of reported abstinence. On the day of surgery (end of treatment), 52% of CM patients were abstinent compared with 16% of patients in MO (risk ratio = 3.2 [1.1-9.3]; p = .03). At the 3-month follow-up, 43% of CM patients were abstinent compared with 5% in MO (risk ratio = 8.4 [1.5-48.3]; p = .02).ConclusionsProviding monetary incentives contingent on abstinence prior to cancer surgery may produce significant improvements in smoking abstinence rates relative to breath CO MO.ImplicationsIn this pilot preoperative CM intervention for smoking abstinence, patients receiving a CM intervention prior to cancer surgery had a greater probability of smoking abstinence at the end of treatment compared with a breath MO group (52% vs. 16%, respectively). Thus, providing monetary incentives contingent on abstinence may produce significant improvements in smoking abstinence rates prior to cancer surgery relative to breath CO monitoring.

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