An interventional study of Nicotine cessation program in Nicotine Use and Tobacco Use, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
Given the challenges to delivering tobacco cessation treatment in oncology care and the unique challenges faced by individuals attempting to quit tobacco after a cancer diagnosis, scalable cessation programs that are tailored to the experiences of cancer survivors that also integrate caregiver/family support are needed. To address this need, this study will use an intervention that consists of two primary strategies: 1) a tailored cessation program for cancer survivors and family members/caregivers who use tobacco and 2) healthcare provider training.
Healthcare providers will receive training on the AAC model (Ask patients about tobacco use, Advise patients to quit, Connect patients to cessation resources), including materials focused on tobacco cessation in cancer care from the CDC, as well as a brief evidence-based communication skills training based on the C-LEAR (Counsel, Listen, Empathize, Answer, Recommend) approach.
125 studies on the registry are indexed under Tobacco Use; 65 are open to participants now.
This study's planned enrollment of 204 is above the median of 150 across 119 interventional studies indexed under Tobacco Use.
Browse Tobacco Use studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Cancer Survivors including Current Cancer Patients
Informal Caregivers/Family Members of Cancer Survivors
Exclusion Criteria:
Cancer Survivors including Current Cancer Patients
Informal Caregivers/Family Members of Cancer Survivors
Behavioral: Nicotine cessation program
All participants will complete a nicotine cessation program designed by Area Health Education Center (AHEC). The focus is on known tobacco cessation techniques and motivations to quit with additional focuses on cancer survivors and caregivers. The program consists of 4 sessions (each session is approximately 60 minutes long) that will be delivered by a Tobacco Treatment Specialist by either videoconference or by telephone. Dyad enrollees (i.e., cancer survivors and their caregiver/family member) will complete sessions together. Participants will also be eligible for free nicotine replacement therapy while on study if medically appropriate.
Program reach for cancer survivors
Determine the reach of the nicotine cessation program used in this study for cancer survivors. This is defined as the proportion of eligible patients enrolled (i.e., agreed to participate and consented) during the study period.
Time frame: Baseline
Program reach for caregivers/family members of cancer survivors
Determine the reach of the nicotine cessation program used in this study for caregivers/family members of cancer survivors. This is defined as the proportion of enrolled cancer survivors who also have a family member/caregiver enrolled.
Time frame: Baseline
Program effectiveness in tobacco cessation
Determine the effectiveness of the nicotine cessation program used in this study in tobacco cessation. Tobacco cessation will be measured by self-reported 7-day point prevalence abstinence (i.e., no use of any tobacco product over the previous 7 days).
Time frame: Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions
Program effectiveness in tobacco cessation
Determine the effectiveness of the nicotine cessation program used in this study in tobacco cessation. Tobacco cessation will be measured by self-reported 7-day point prevalence abstinence (i.e., no use of any tobacco product over the previous 7 days).
Time frame: Either 3 months after nicotine cessation program completion or 5 months after baseline assessment for participants who do not complete the program sessions
Clinic-level adoption of the study intervention
Determine the clinic-level adoption of the study intervention, which is defined as the proportion of eligible patients enrolled by clinic
Time frame: 18 months
Healthcare provider-level adoption of the study intervention
Determine the healthcare provider-level adoption of the study intervention, which is defined as the proportion of eligible healthcare providers participating in the healthcare provider training for this study.
Time frame: 1-2 weeks
Participant satisfaction
Determine participant satisfaction with the nicotine cessation program used in this study, which will be measured using a 4-point Lickert scale.
Time frame: Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions
Participant adherence
Determine participant adherence to the nicotine cessation program used in this study, as measured by the number of sessions completed (out of 4).
Time frame: 8 weeks after baseline assessment
Participant perspectives on program feasibility and acceptability
Assess participant perspectives on program feasibility and acceptability, using qualitative interviews.
Time frame: Up to 4 weeks after program completion
Healthcare provider perspectives on intervention feasibility and acceptability
Assess healthcare provider perspectives on intervention feasibility and acceptability, using qualitative interviews.
Time frame: 18 months
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