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

Fred Hutchinson Cancer Center (FHCC)

Status: Begins enrollment in 2 months

Conditions: Lung Carcinoma

Treatments: Other: Educational Intervention; Other: Electronic Health Record Review; Other: Interview; Other: Survey Administration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07490860

RG1126204

NCI-2026-01261 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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57 participants in 2 patient groups

Aim 1: Community advisory board (CAB) meetings

No Intervention group

Description:

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.

Aim 2: Lung cancer screening (LCS) decision-making support session (intervention)

Experimental group

Description:

Participants attend an in-person restorative justice-based LCS decision-making support session over 2-3 hours on study.

Treatment:

Other: Survey Administration

Other: Interview

Other: Electronic Health Record Review

Other: Educational Intervention