Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers

NCT06851936 | Recruiting DMC

• 2 other identifiers: UF-CCPS-039IRB202500401
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

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

Keywords

tobacco cessation; AHEC; cancer survivors; tobacco; nicotine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Program reach for caregivers/family members of cancer survivors

  Baseline

• Program effectiveness in tobacco cessation

  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

  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

  18 months

• Healthcare provider-level adoption of the study intervention

  1-2 weeks

Study Arms (1)

Nicotine Cessation Program

EXPERIMENTAL

Behavioral: Nicotine cessation program

Interventions

Nicotine cessation program BEHAVIORAL

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.

Nicotine Cessation Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use; Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Jennifer LeLaurin, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erika Barahona, M. Ed

CONTACT

352-273-7345; ebarahona@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 28, 2025
• Study Start: July 11, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Locations

US (1)