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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Carcinoma
• Intervention / Treatment: Other: Survey Administration; Other: Interview; Other: Electronic Health Record Review; Other: Educational Intervention

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 study intervention, participants in aim 2 are followed up at 90 days.

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Triplette, MD, MPH; Phone Number: 206-667-6335; Email: Mtriplet@fredhutch.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Matthew Triplette, MD, MPH; Phone Number: 206-667-6335; Email: Mtriplet@fredhutch.org
      • Principal Investigator: Matthew Triplette, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Other: Survey Administration; Ancillary studies; Other: Interview; Ancillary studies; Other: Electronic Health Record Review; Ancillary studies; Other: Educational Intervention; Attend LCS decision-making support session

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: AstraZeneca; Go2 Foundation
• Investigators: Principal Investigator: Matthew Triplette, MD, MPH, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Interviews as Topic; Early Intervention, Educational
• Other Study ID Numbers: RG1126204; NCI-2026-01261 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No