Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Program reach for cancer survivors
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Nicotine Cessation Program
干预措施: Nicotine cessation program (Behavioral)
结局指标
主要结局
Program reach for cancer survivors
时间窗: 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.
次要结局
- Program reach for caregivers/family members of cancer survivors(Baseline)
- 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)
- 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)
- Participant adherence(8 weeks after baseline assessment)
- Participant perspectives on program feasibility and acceptability(Up to 4 weeks after program completion)
- Healthcare provider perspectives on intervention feasibility and acceptability(18 months)
- 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)