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临床试验 NCT07490860 针对肺癌目前尚未招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
A Restorative Justice-Based Lung Cancer Screening Decision-Making Support Intervention Tailored for Black Individuals to Increase Lung Cancer Screening Among Black Community Members, RESTORE Trial 57
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临床试验NCT07490860是一项针对肺癌的干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年7月1日开始，预计招募57名患者。该研究由Fred Hutchinson Cancer Center主导，计划于2026年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月24日。
简要概括
This clinical trial develops and studies whether a restorative justice-based lung cancer screening (LCS) decision-making support intervention tailored for Black individuals increases LCS among Black community members. Lung cancer remains the leading cause of cancer deaths among Black men and women. LCS with yearly low-dose chest computed tomography (CT) is recommended for people with current or recent tobacco use (wi...显示更多
详细描述
OUTLINE: Participants are assigned to 1 of 2 aims.
AIM 1: Participants attend community advisory board (CAB) meetings over 60 minutes on study in support of the co-development and adaptation of the restorative justice-based LCS decision-making support intervention.
AIM 2: Participants attend an in-person restorative justice-based LCS decision-making support session over 2-3 hours on study.
After completion of stud...
显示更多官方标题
Integrating Restorative Practices to Enhance Shared Decision-Making and Uptake of Lung Cancer Screening in Black Community Members (RESTORE)
疾病
肺癌其他研究标识符
NCT编号
实际开始日期
2026-07-01
最近更新发布
2026-03-24
预计完成日期
2026-12-31
计划入组人数
57
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
尚未招募
主要目的
筛查
分配方式
非随机
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
无干预Aim 1: Community advisory board (CAB) meetings Participants attend CAB meetings over 60 minutes on study in support of the co-development and adaptation of the restorative justice-based LCS decision-making support intervention. | 不适用 |
实验性Aim 2: Lung cancer screening (LCS) decision-making support session (intervention) Participants attend an in-person restorative justice-based LCS decision-making support session over 2-3 hours on study. | 教育干预 Attend LCS decision-making support session 调查管理 Ancillary studies 访谈 Ancillary studies 电子健康记录审查 Ancillary studies |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Intervention acceptability | Assessed using the Acceptability of Intervention Measure (AIM). The AIM will be summarized and presented as a range of scores from 1 (low acceptability/appropriateness) to 5 (high acceptability/appropriateness). | At post-intervention (Day 1) |
Lung cancer screening knowledge | Will be assessed using the Lung Cancer Screening Knowledge 7 question score. Pre- and post-intervention responses will be compared via Chochran-Mantel-Haenszel and Friedman tests. | At pre- and post-intervention (both on Day 1) |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Readiness to screen | Will be assessed using the Lung Cancer Screening Health Belief Scales. Participant responses will be summarized with the median and range of scores at pre- and post-intervention. | At pre- and post-intervention (both on Day 1) |
Medical mistrust | Will be assessed using the Discrimination in Medical Setting and Group-Based Medical Mistrust scale. Participant responses will be summarized with the median and range of scores at pre- and post-intervention. | At pre- and post-intervention (both on Day 1) |
Perceived smoking-related stigma | Will be assessed using the Cataldo Lung Cancer Stigma Scale: smoking-related subscale. Participant responses will be summarized with the median and range of scores at pre- and post-intervention. | At pre- and post-intervention (both on Day 1) |
Shared decision-making (SDM) process | Will be assessed using the Shared Decision Making Questionnaire. Participant responses will be summarized with the median and range of scores, with 0 indicating no SDM behavior and 100 indicating ideal SDM behavior. | At post-intervention (Day 1) |
Completion of chest computed tomography (CT) | Will assess completion of chest CT within 90 days post-intervention with no comparison. | Up to 90 days post-intervention |
Intervention acceptability and refinement | Will recruit a subset of participants to participate in a semi-structured interview post-intervention to gain an in-depth understanding of intervention acceptability and intervention refinement, including participant perspectives about the integration of restorative justice-based lung cancer screening decision-making support. Qualitative interview data will be analyzed using a mixed inductive-deductive approach to thematic analysis. | At 90 days post-intervention |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
- AIM 1: At least 18 years of age
- AIM 1: Individuals who represent LCS-eligible patients, serve as members of Black/African American (AA)-serving community-based organizations (CBOs), and represent key providers, public health, nursing, and medical staff stakeholders
- AIM 2: Identify as Black or African American
- AIM 2: Between ages 50-77
- AIM 2: Self-reported 20-pack year smoking history
- AIM 2: Ongoing commercial tobacco use within the past 15 years
- AIM 2: Proficiency in the English language
- AIM 1: Under 18 years of age
- AIM 1: Non-English speaking community advisory board (CAB) members
- AIM 1: Inability to read written English
- AIM 2: Has a documented chest CT within the past one year
- AIM 2: Personal history of lung cancer or symptoms associated with lung cancer
Fred Hutchinson Cancer Center- 阿斯利康
- Go2 Foundation
研究中心联系人
联系人: Matthew Triplette, MD, MPH, 206-667-6335, [email protected]
1 位于 1 个国家/地区的研究中心
Washington
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States
Matthew Triplette, MD, MPH, 联系人, 206-667-6335, [email protected]
Matthew Triplette, MD, MPH, 主要研究者