This clinical trial evaluates whether switching to electronic (e)-cigarettes can improve smoking cessation in smokers who aren't interested in traditional tobacco treatment options. For patients in cancer care, quitting smoking is critical, but a significant portion of patients in cancer care refuse all components of tobacco treatment, even when offered free of charge. E-cigarettes have been shown to reduce cigarette smoking and promote smoking cessation/abstinence, thereby reducing the negative health effects of traditional cigarettes. Switching to e-cigarettes may be a safer and acceptable alternative to traditional cigarettes for smokers who refuse traditional tobacco treatment methods.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07039292.
Locations matching your search criteria
United States
South Carolina
Charleston
Medical University of South CarolinaStatus: Active
Contact: Alana M Rojewski
Phone: 843-876-1593
PRIMARY OBJECTIVE:
I. Assess the impact of a switching approach on cigarette smoking behavior.
SECONDARY OBJECTIVE:
I. To characterize key determinants of intervention implementation outcomes using a mixed methods approach.
EXPLORATORY OBJECTIVES:
I. Characterize the impact of a switching approach on biological effects of cancer risk and health symptoms including:
Ia. Evaluate pro- versus (vs.) anti-inflammatory cytokines and chemokines and deoxyribonucleic acid (DNA) damage between groups to assess combustible smoking and e-cigarette related changes;
Ib. Evaluate the Centers for Disease Control and Prevention (CDC) Health-Related Quality of Life measure between groups.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive a list of tobacco treatment resources they can engage with at any time. If participants choose to engage in a quit attempt, they also receive a reasons for quitting worksheet, self-monitoring log, and educational materials about smoking cessation. Participants also undergo collection of blood samples throughout the trial.
ARM II: Participants choose a target switch date (approximately 7-14 days after baseline) and receive a study-supplied e-cigarette. Participants use the study-supplied e-cigarette as desired while continuing to smoke their regular cigarettes for 1 week and then, on their target switch date, switch completely to e-cigarettes for 12 weeks. Participants receive a reasons for switching worksheet, self-monitoring log, and educational materials about smoking cessation. Participants also receive text messages the day before and the day of their target switch date to remind them of their behavioral plans and encourage them to switch completely. Participants also undergo collection of blood samples throughout the trial.
After completion of study intervention, participants are followed up at week 24 and then by medical record review up to 5 years.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMedical University of South Carolina
Principal InvestigatorAlana M Rojewski
