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| ID | Type | Description | Link |
|---|---|---|---|
| IRB202500401 | Other Identifier | University of Florida |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nicotine Cessation Program | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Program reach for caregivers/family members of cancer survivors | 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. | Baseline |
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Inclusion Criteria:
Cancer Survivors including Current Cancer Patients
Informal Caregivers/Family Members of Cancer Survivors
Exclusion Criteria:
Cancer Survivors including Current Cancer Patients
Informal Caregivers/Family Members of Cancer Survivors
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erika Barahona, M. Ed | Contact | 352-273-7345 | ebarahona@ufl.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer LeLaurin, PhD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32608 | United States |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D020340 | Tobacco Use Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| Program effectiveness in tobacco cessation |
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). |
| 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 | 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). | 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 | Determine the clinic-level adoption of the study intervention, which is defined as the proportion of eligible patients enrolled by clinic | 18 months |
| Healthcare provider-level adoption of the study intervention | 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. | 1-2 weeks |
| Participant satisfaction | Determine participant satisfaction with the nicotine cessation program used in this study, which will be measured using a 4-point Lickert scale. | Either 1 week after nicotine cessation program completion or 8 weeks after baseline assessment for participants who do not complete the program sessions |
| Participant adherence | Determine participant adherence to the nicotine cessation program used in this study, as measured by the number of sessions completed (out of 4). | 8 weeks after baseline assessment |
| Participant perspectives on program feasibility and acceptability | Assess participant perspectives on program feasibility and acceptability, using qualitative interviews. | Up to 4 weeks after program completion |
| Healthcare provider perspectives on intervention feasibility and acceptability | Assess healthcare provider perspectives on intervention feasibility and acceptability, using qualitative interviews. | 18 months |