Contingency Management for Veteran Smokers With or at Risk for Cancer

Veterans Affairs Med Ctr San Francisco, San Francisco CA

Investigators

Abstract

The goal of this Proof of Concept and Clinical Trial project is to evaluate the acceptability, feasibility, and efficacy of Contingency Management (CM) for smoking cessation among Veterans in lung cancer screening (LCS) or cancer care in Veterans Affairs (VA) clinics. Smoking at the time of LCS or cancer diagnosis is associated with treatment failure, shortened lifespan, and diminished quality of life. Beyond the increased morbidity and mortality, smoking after a cancer diagnosis is associated with an estimated $3.4 billion in healthcare costs. Despite these risks, the VA does not routinely integrate smoking cessation treatment into LCS screening or cancer care, and quit rates are low. CM is a behavioral treatment that promotes cessation through positive reinforcement through delivery of incentives (rewards) when abstinence is biologically verified. Newer CM technologies allow for remote (mobile) biological verification of smoking abstinence, increasing scalability of CM for smoking cessation among outpatients. Research indicates that CM must be tailored to the clinical population and context. This staged investigation will occur in three phases. In Year 1 (Focus Groups), we will iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care (n=15) and LCS and oncology staff (n=10) (Aim 1). In Year 2 (Pilot Study), we will examine the feasibility of mobile smoking cessation CM with for VA patients in LCS or in cancer care (Aim 2). In a single arm study (n=20), Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks. Measures will be completed at Week 0 (Baseline) and 5 (Study End). We will use the following Go/No Go criteria as endpoints to measure success: 1) completion of core staff hiring and training; 2) adaptation of CM protocols for VA patients in LCS or cancer care and refinement of fidelity measures/procedures; 3) feasibility, as evidenced by ability to recruit ≥70% of the target sample within the 12 month timeline; 4) engagement, as measured by ≥50% of participants attending ≥25% CM sessions and ≥25% video uploads during the CM phase (Weeks 2-5); 5) completion of study measures at Study End (Week 5) in ≥60% of enrolled participants; 6) data quality checks for enrolled participants. If the pilot study is successful by the above criteria, we will conduct a Randomized Controlled Trial (RCT) (Yrs 3-6) to assess efficacy of mobile CM compared with treatment as usual (TAU) (Aim 3). Veterans diagnosed with cancer or in LCS will be randomized to receive a 5-week CM condition (CM plus behavioral counseling) or TAU (referral to VA Tobacco Cessation Clinic and VA quitline). Both groups will receive pharmacotherapy. Endpoints will be measured at Weeks 5, 12, and 24. Hypothesis 1 is that compared to TAU, the CM condition will show improvements in treatment engagement (motivation to quit (Contemplation Ladder); adherence with TUD medication (Timeline Followback, TLFB)). Hypothesis 2 is that compared to TAU, the CM condition will show improvements in smoking cessation outcomes (cigarettes per day (TLFB); quit attempts; and nicotine dependence severity (Fagerström Test of Nicotine Dependence, FTND)). As an Exploratory Aim, we will assess seven-day point prevalence cigarette abstinence, assessed through self-report and exhaled carbon monoxide (CO) and/ or salivary cotinine levels, as clinically indicated. This groundbreaking investigation leverages novel CM approaches to improve smoking cessation outcomes in high-risk patients with or at risk for cancer.