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Recruiting NCT07490860

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

No phase Interventional Lung Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educational Intervention, Survey Administration, Interview, Electronic Health Record Review.
Who it may be relevant to
Registry conditions: Lung Carcinoma. Basic parameters: 50 years — 77 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other Educational Intervention
    Attend LCS decision-making support session
  • Other Survey Administration
    Ancillary studies
  • Other Interview
    Ancillary studies
  • Other Electronic Health Record Review
    Ancillary studies

Primary outcome measures

  • Intervention acceptability [Time frame: At post-intervention (Day 1)]
  • Lung cancer screening knowledge [Time frame: At pre- and post-intervention (both on Day 1)]
Secondary outcome measures (6)
  • Readiness to screen [Time frame: At pre- and post-intervention (both on Day 1)]
  • Medical mistrust [Time frame: At pre- and post-intervention (both on Day 1)]
  • Perceived smoking-related stigma [Time frame: At pre- and post-intervention (both on Day 1)]
  • Shared decision-making (SDM) process [Time frame: At post-intervention (Day 1)]
  • Completion of chest computed tomography (CT) [Time frame: Up to 90 days post-intervention]
  • Intervention acceptability and refinement [Time frame: At 90 days post-intervention]

Eligibility criteria

Inclusion criteria

  • Identify as Black or African American
  • Between ages 50-77
  • Self-reported 20-pack year smoking history
  • Ongoing commercial tobacco use within the past 15 years
  • Proficiency in the English language

Exclusion criteria

  • Has a documented chest CT within the past one year
  • Personal history of lung cancer or symptoms associated with lung cancer

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

United States · 1 center
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT07490860 · RG1126204 · NCI-2026-01261 · FHIRB0021187

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗