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临床试验/NCT06289192
NCT06289192已完成4 期

Feasibility, Acceptability, and Piloting of a Virtual Counselor Tobacco Cessation Intervention With Community Health Worker Linkage to Lung Cancer Screening

Johns Hopkins University3 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年4月30日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

Experimental

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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