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
Integrating Restorative Practices to Enhance Shared Decision-Making and Uptake of Lung Cancer Screening in Black Community Members (RESTORE)
2 other identifiers
interventional
57
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 24, 2026
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
Study Completion
Last participant's last visit for all outcomes
December 31, 2026
May 22, 2026
March 1, 2026
6 months
March 10, 2026
May 20, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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)
Secondary Outcomes (6)
Readiness to screen
At pre- and post-intervention (both on Day 1)
Medical mistrust
At pre- and post-intervention (both on Day 1)
Perceived smoking-related stigma
At pre- and post-intervention (both on Day 1)
Shared decision-making (SDM) process
At post-intervention (Day 1)
Completion of chest computed tomography (CT)
Up to 90 days post-intervention
- +1 more secondary outcomes
Study Arms (2)
Aim 1: Community advisory board (CAB) meetings
NO INTERVENTIONParticipants 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.
Aim 2: Lung cancer screening (LCS) decision-making support session (intervention)
EXPERIMENTALParticipants attend an in-person restorative justice-based LCS decision-making support session over 2-3 hours on study.
Interventions
Attend LCS decision-making support session
Ancillary studies
Ancillary studies
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- AstraZenecacollaborator
- Go2 Foundationcollaborator
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Matthew Triplette, MD, MPH
Fred Hutch/University of Washington Cancer Consortium
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2026
First Posted
March 24, 2026
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
May 22, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share