Nicotine Use, Tobacco Use
Conditions
Keywords
tobacco cessation, AHEC, cancer survivors, tobacco, nicotine
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.
Interventions
BEHAVIORALNicotine 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.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 1 week after nicotine cessation program completion or 8 weeks 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. |
Countries
United States
Contacts
CONTACTErika Barahona, M. Ed
PRINCIPAL_INVESTIGATORJennifer LeLaurin, PhD
University of Florida
Outcome results
None listed