Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers

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.

Study Overview

• Status: Recruiting
• Conditions: Tobacco Use; Nicotine Use
• Intervention / Treatment: Behavioral: Nicotine cessation program

• Study Type: Interventional
• Enrollment (Estimated): 204
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Erika Barahona, M. Ed; Phone Number: 352-273-7345; Email: ebarahona@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Recruiting
      • University of Florida
      • Contact: Erika Barahona, M. Ed; Phone Number: 352-273-7345; Email: ebarahona@ufl.edu
      • Principal Investigator: Jennifer LeLaurin, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Cancer Survivors including Current Cancer Patients

• Current self-reported user of any tobacco/nicotine product at time of baseline screening assessment (e.g., cigarettes, e-cigarettes, cigars, dip/chew) in the past month.
• Any history of cancer diagnosis. Subjects currently receiving cancer-related treatments are eligible for enrollment.
• Receiving care from the participating UF Health clinics (Medical Oncology, Urology, and Radiation Oncology).
• Capable of completing study requirements
• Informed consent obtained from the subject and documentation of subject agreement to comply with all study-related processes
• Adults aged ≥18 years

Informal Caregivers/Family Members of Cancer Survivors

• Current self-reported user of any tobacco/nicotine product at time of baseline screening assessment (e.g., cigarettes, e-cigarettes, cigars, dip/chew) in the past month.
• A family member, informal caregiver, or friend of an enrolled cancer survivor receiving care from the participating UF Health clinics as described above
• Capable of completing study requirements
• Informed consent obtained from the subject and documentation of subject agreement to comply with all study-related processes
• Adults aged ≥18 years

Exclusion Criteria:

Cancer Survivors including Current Cancer Patients

• Patients unable to complete the sessions because of language, travel or technology barriers
• Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Informal Caregivers/Family Members of Cancer Survivors

• Participants unable to complete the sessions because of language, travel or technology barriers
• Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Nicotine Cessation Program

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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).	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).	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	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.	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.	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).	8 weeks after baseline assessment
Participant perspectives on program feasibility and acceptability	Assess participant perspectives on program feasibility and acceptability, using qualitative interviews.	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.	18 months

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Jennifer LeLaurin, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 21, 2026

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 24, 2025
• First Posted (Actual): February 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: tobacco; nicotine; tobacco cessation; cancer survivors; AHEC
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Tobacco Use; Tobacco Use Cessation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: UF-CCPS-039; IRB202500401 (Other Identifier: University of Florida)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No