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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-01261 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| FHIRB0021187 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Go2 Foundation | UNKNOWN |
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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 (within 15 years) who are aged 50-80 with at least a 20 pack-year smoking history. LCS lowers lung cancer death by 20%; however, data shows that LCS completion remains low among minority groups in the United States. The restorative justice-based LCS decision-making support intervention in this trial has been specifically tailored to meet the needs of Black individuals. It is designed to reduce racial unfairness by promoting trust, shared understanding, and empowerment in clinical decision making while addressing the social and historical circumstances of health inequalities. This may be an effective way to increase LCS among Black community members.
OUTLINE:
Participants attend an in-person restorative justice-based LCS decision-making support session over 2-3 hours on study.
After completion of study intervention, participants may be followed up at 90 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening [Lung cancer screening (LCS) decision-making support session] | Experimental | Participants attend an in-person restorative justice-based LCS decision-making support session over 2-3 hours on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Attend LCS decision-making support session |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Triplette, MD, MPH | Contact | 206-667-6335 | Mtriplet@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Triplette, MD, MPH | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Recruiting | Seattle | Washington | 98109 | United States |
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| Survey Administration | Other | Ancillary studies |
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| Interview | Other | Ancillary studies |
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| Electronic Health Record Review | Other | Ancillary studies |
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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 |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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