Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Lung Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

50 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location status: Recruiting

Location contact

Matthew Triplette, MD, MPH

CONTACT

[email protected]

206-667-6335

Matthew Triplette, MD, MPH

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Attend LCS decision-making support session

Survey Administration

Other

Ancillary studies

interview

Other

Ancillary studies

Electronic Health Record Review

Other

Ancillary studies

Primary outcomes

  1. Intervention acceptability

    Time frame: At post-intervention (Day 1)

    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).

  2. Lung cancer screening knowledge

    Time frame: At pre- and post-intervention (both on Day 1)

    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.

Secondary outcomes

  1. Readiness to screen

    Time frame: At pre- and post-intervention (both on Day 1)

    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.

  2. Medical mistrust

    Time frame: At pre- and post-intervention (both on Day 1)

    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.

  3. Perceived smoking-related stigma

    Time frame: At pre- and post-intervention (both on Day 1)

    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.

  4. Shared decision-making (SDM) process

    Time frame: At post-intervention (Day 1)

    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.

  5. Completion of chest computed tomography (CT)

    Time frame: Up to 90 days post-intervention

    Will assess completion of chest CT within 90 days post-intervention with no comparison.

  6. Intervention acceptability and refinement

    Time frame: At 90 days post-intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew Triplette, MD, MPH

CONTACT

[email protected]

206-667-6335

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • AstraZeneca
  • Go2 Foundation

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.