Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers

NCT ID: NCT06851936

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-11
• Study Completion Date: 2026-11-30

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nicotine Cessation Program

Group Type: EXPERIMENTAL

Nicotine cessation program

Intervention Type: 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.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer LeLaurin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

University of Florida

Gainesville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Erika Barahona, M. Ed

Role: CONTACT

ebarahona@ufl.edu

352-273-7345

Facility Contacts

Erika Barahona, M. Ed

Role: primary

ebarahona@ufl.edu

352-273-7345

Other Identifiers

IRB202500401

Identifier Type: OTHER

Identifier Source: secondary_id

UF-CCPS-039

Identifier Type: -

Identifier Source: org_study_id