Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers

Not Applicable

Not yet recruiting

• Conditions: Nicotine Use; Tobacco Use

• Registration Number: NCT06851936
• Lead Sponsor: University of Florida

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-24
• Last Update Submitted: 2025-02-24
• Study First Posted: 2025-02-28
• Last Update Posted: 2025-02-28
• Study Start: 2025-05
• Primary Completion: 2026-05
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 204

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Program reach for cancer survivors	Baseline	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.

Secondary Outcome Measures

Name	Time	Method
Program reach for caregivers/family members of cancer survivors	Baseline	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.
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	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).
Clinic-level adoption of the study intervention	18 months	Determine the clinic-level adoption of the study intervention, which is defined as the proportion of eligible patients enrolled by clinic
Healthcare provider-level adoption of the study intervention	1-2 weeks	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.
Participant satisfaction	Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions	Determine participant satisfaction with the nicotine cessation program used in this study, which will be measured using a 4-point Lickert scale.
Participant adherence	8 weeks after baseline assessment	Determine participant adherence to the nicotine cessation program used in this study, as measured by the number of sessions completed (out of 4).
Participant perspectives on program feasibility and acceptability	Up to 4 weeks after program completion	Assess participant perspectives on program feasibility and acceptability, using qualitative interviews.
Healthcare provider perspectives on intervention feasibility and acceptability	18 months	Assess healthcare provider perspectives on intervention feasibility and acceptability, using qualitative interviews.