This phase IV trial compares the effect of high (enhanced)- intensity treatment to standard low-intensity treatment for the prevention of smoking during cancer care. Combustible cigarette smoking is a leading preventable cause of cancer and continued smoking after diagnosis is associated with poor clinical outcomes. In an opt-out referral system, patients are automatically referred to a proactive smoking treatment service that offers quitting assistance, unless the patient has specifically requested that they not receive such offers. An opt-out referral to a centralized smoking treatment outreach program may be a promising way to equitably engage more people with cancer in effective smoking cessation interventions while imposing little to no burden on clinic staff or providers. The high-intensity treatment may be more effective than the standard low-intensity treatment at helping cancer patients quit smoking.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06218823.
PRIMARY OBJECTIVES:
I. To establish the feasibility of the comparative effectiveness trial (CET) protocol and procedures in preparation for a full-scale future trial. (PROPOSED PILOT CET)
II. To generate estimates of the size of the comparative effects of enhanced, cancer-specific smoking cessation treatment versus a generic standard care package similar to quitline care in terms of biochemically confirmed 7-day point prevalence abstinence (no smoking in the past 7 days) 12 and 26 weeks after a target quit date. (PROPOSED PILOT CET)
SECONDARY OBJECTIVES:
I. To estimate differences in CET arms in secondary outcomes including patient acceptability, completion, adherence, costs, and cost-effectiveness. (PILOT CET)
II. To estimate the extent to which intensive, cancer-specific treatment differs from the control treatment on these outcomes relative to control. (PILOT CET)
III. To estimate the extent to which treatment effects on abstinence and secondary outcomes differ across patient subpopulations based on demographics (age, race, sex, ethnicity, socioeconomic disadvantage); nicotine dependence; and cancer site, stage, and treatment phase. (PILOT CET)
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive standard low-intensity treatment consisting of applying nicotine patches daily (QD) for 2 weeks, receive 3 smoking cessation counseling calls, and receive information about standard quitline and SmokefreeTXT services. Patients also undergo carbon monoxide breath and urine or saliva sample collection during follow-up.
ARM II: Patients receive high-intensity treatment consisting of receiving varenicline orally (PO) 1-2 times daily (QD-BID) for 12 weeks and 7 cancer-specific smoking cessation counseling calls. Patients who are ineligible for varenicline, will be offered 12 weeks of nicotine patch therapy. Patients will be offered referral or enrollment to standard quitline and SmokefreeTXT services. Patients also undergo carbon monoxide breath and urine or saliva sample collection during follow-up.
After completion of study intervention, patients are followed up at 8 and 26 weeks.
Lead OrganizationUniversity of Wisconsin Carbone Cancer Center - University Hospital
Principal InvestigatorDanielle Mccarthy
