Feasibility, Acceptability, and Piloting of a Virtual Counselor Tobacco Cessation Intervention With Community Health Worker Linkage to Lung Cancer Screening
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 3
- 主要终点
- Acceptability and Feasibility as Assessed by the Number of Participants Who Complete Intervention and Surveys
研究概览
简要总结
To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker (CHW) support and navigation to lung cancer screening in low-income housing units in Baltimore, the investigators propose to collect data on intervention acceptability and feasibility among individuals in public housing as well as feedback on use of shared decision making when referring for low-dose chest CT (LDCT).
The investigators will conduct a feasibility pilot study of a virtual counselor plus community health worker intervention. With a sample of participants from public housing units (N=15), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month and 3 months. At the end of three months, the investigators will conduct follow up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on this information, the investigators will make iterative improvements to the combined intervention.
详细描述
In anticipation of a future two-arm type 1 hybrid effectiveness-implementation randomized controlled trial comparing a virtual counselor-led computer delivered intervention (VCTC) augmented with CHW support in low-income housing units in Baltimore City. This pilot study will generate preliminary data for a larger study. The investigators will conduct a feasibility pilot study of the entire VCTC and CHW intervention with a sample of participants (N=15) to collect data on the feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, one month, and three months. At the end of three months, the investigators will conduct follow-up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on the information collected in these efforts, the investigators will make iterative improvements to the existing intervention, aligned with user-experience design procedures.
Participants will be recruited through flyers posted in and around the housing units and distributed to tenants by housing unit staff. Flyers will describe the study and contain a study phone number to call. Information may also be distributed by study staff during non-study-related health and wellness activities conducted at the sites. At initial contact, a study staff member will discuss the study purpose and determine eligibility. If eligible, the staff member will proceed to discuss requirements, review risks and benefits, and obtain informed consent from interested participants.
Consent process: After confirming eligibility with screening questions via phone, potential participants will be offered the option of reviewing the study information and consent form over a Zoom video conference. Regardless of whether the participants choose to review this information in advance, all potential participants will complete the consent process and sign the consent form at the beginning of the first in-person visit, which will be conducted on-site at the participants housing community.
Baseline Assessment: This will occur on the same day as the in-person portion of the consent process. Initial evaluation will comprise the research assessments detailed in Table 1, including demographics, a clinical history, a tobacco use history, and a number of tobacco-related measures. Assessments will be self-administered via tablet computer.
Intervention:
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
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 or older
- •Current tobacco use with >100 cigarettes smoked in their lifetime
- •English speaking (intervention currently in English only and housing units are in largely English-speaking neighborhoods)
- •Considering smoking cessation
- •Planning to remain in current housing unit for 6 months
排除标准
- •Current use of pharmacological treatment for tobacco cessation
- •Contraindication to nicotine replacement therapy
- •Current engagement in formal smoking cessation program
- •Major cognitive or psychiatric impairment
- •Severe hearing impairment
- •Investigator discretion
研究组 & 干预措施
Smoking Cessation Intervention
Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 3 months. Assessments will be conducted at baseline, 1 month, and 3 months.
干预措施: C-Raven Virtual Tobacco Cessation Counseling (Behavioral)
Smoking Cessation Intervention
Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 3 months. Assessments will be conducted at baseline, 1 month, and 3 months.
干预措施: Nicotine Replacement Product (Drug)
Smoking Cessation Intervention
Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 3 months. Assessments will be conducted at baseline, 1 month, and 3 months.
干预措施: Community Health Worker (Other)
Smoking Cessation Intervention
Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 3 months. Assessments will be conducted at baseline, 1 month, and 3 months.
干预措施: Lung Cancer Screening (Other)
结局指标
主要结局
Acceptability and Feasibility as Assessed by the Number of Participants Who Complete Intervention and Surveys
时间窗: 3 months
Acceptability and Feasibility will be assessed by the number of participants who complete intervention and surveys
Acceptability and Feasibility as Assessed by Barriers to Screening
时间窗: Baseline, 1 month, 3 months
Acceptability and Feasibility will be assessed by barriers to screening
次要结局
- Number of Participants That Uptake Nicotine Replacement Therapy(3 months)
- Participant Engagement With Community Health Worker (CHW) as Assessed by Number of CHW Interactions(3 months)
