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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

Not yet recruiting
Clinical Trial NCT07490860 is an interventional study for Lung Carcinoma and is currently not yet recruiting. Enrollment is planned to begin on 1 July 2026 and continue until the study accrues 57 participants. Led by Fred Hutchinson Cancer Center, this study is expected to complete by 31 December 2026. The latest data from ClinicalTrials.gov was last updated on 24 March 2026.
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 (wi...Show More
Detailed Description
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...

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Official Title

Integrating Restorative Practices to Enhance Shared Decision-Making and Uptake of Lung Cancer Screening in Black Community Members (RESTORE)

Conditions
Lung Carcinoma
Other Study IDs
NCT ID Number
NCT07490860
Start Date (Actual)
2026-07-01
Last Update Posted
2026-03-24
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
57
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Screening
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
No InterventionAim 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.
N/A
ExperimentalAim 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.
Educational Intervention
Attend LCS decision-making support session
Survey Administration
Ancillary studies
Interview
Ancillary studies
Electronic Health Record Review
Ancillary studies
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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
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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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 logoFred Hutchinson Cancer Center
Study Central Contact
Contact: Matthew Triplette, MD, MPH, 206-667-6335, [email protected]
1 Study Locations in 1 Countries

Washington

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States
Matthew Triplette, MD, MPH, Contact, 206-667-6335, [email protected]
Matthew Triplette, MD, MPH, Principal Investigator