Recruiting

Tobacco Cessation

Sponsor:

University of Florida

Code:

NCT06851936

Conditions

Nicotine Use

Tobacco Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Nicotine cessation program

Study Details

Brief summary:

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.

Conditions

Nicotine Use

Tobacco Use

Study ID

NCT06851936

Start date

Jul 11, 2025

Status verified date

May, 2026

Completion date

Oct 21, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

204 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nicotine Cessation Program

Interventions

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.

Primary outcome measure

  • Program reach for cancer survivors [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Erika Barahona, M. Ed

352-273-7345ebarahona@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Erika Barahona, M. Ed

352-273-7345ebarahona@ufl.edu

Principal Investigator:

Jennifer LeLaurin, PhD

More Information

Sponsor

University of Florida

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • tobacco cessation
  • AHEC
  • cancer survivors
  • tobacco
  • nicotine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-05-15.