Grant Number:	1R01CA293735-01A1 Interpret this number
Primary Investigator:	Rojewski, Alana
Organization:	Medical University Of South Carolina
Project Title:	A Novel Harm Reduction Approach for Oncology Outpatients Who Smoke and Refuse Traditional Tobacco Treatment
Fiscal Year:	2025

ABSTRACT The prevalence of cigarette smoking is high for patients being treated for cancer care, and it is critical for these patients to quit smoking. The National Cancer Institute (NCI)’s Cancer Center Cessation Initiative (C3I) provided funding to selected NCI-designated cancer centers to support the integration of evidence-based tobacco treatment into routine cancer care. Yet, only 15.4% of patients at C3I funded centers received at least one component of treatment. Indeed, data from our own C3I funded NCI-designated cancer center show that 23% of oncology outpatients refuse all tobacco treatment. For these patients, novel and appealing interventions that can reduce cigarette smoking and reduce harm from tobacco are urgently needed. Switching from cigarettes to e- cigarettes reduces exposure to carcinogens and may be an appealing harm reduction intervention for patients in cancer care who refuse traditional treatment. We propose a type 1 hybrid effectiveness-implementation trial among oncology outpatients at an NCI-designated cancer center who smoke and refuse all components of tobacco treatment (N=208). We will directly compare rates of switching to e-cigarettes to standard care, and advance understanding of key barriers and facilitators of implementation processes. Participants will be randomly assigned to either 1) an e-cigarette switching approach (Switch), or 2) a control group that receives the standard of care (SC, provision of additional tobacco treatment resources). Participants in the Switch Group will receive a 13-week supply of e-cigarettes (1-week to use ad libitum in advance of switching and 12 weeks to use following their Target Switch Date). The primary outcome is complete switching (abstinence from cigarettes) at Week 12 (Aim 1). We will conduct a mixed methods evaluation of implementation processes for the e-cigarette switching approach (Aim 2). To further evaluate the impact of harm reduction in this population, we will collect exploratory data on the impact of switching to e-cigarettes on the biological effects of cancer risk (i.e., inflammation and DNA damage) and subjective effects of product use on health-related quality of life (Exploratory Aim 3). This study builds upon our preliminary data across a range of studies demonstrating that 1) a sizable portion of oncology outpatients nationally who smoke refuse traditional treatment and plan to continue smoking, 2) an e-cigarette switching approach can significantly reduce cigarette smoking and promote smoking abstinence, even among difficult-to-treat populations, and 3) a harm reduction approach is feasible and acceptable to oncology outpatients. The proposed trial will be led by two seasoned investigators in collaboration with a strong group of Co-Investigators with expertise in smoking cessation, cancer care, harm reduction, non-combustible tobacco products, and clinical trials. The proposed trial is highly significant, no matter the results, and has the potential to influence harm reductions approaches for tobacco among patients in cancer care.





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