Lung CarcinomaNCT07490860
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
A study testing Educational Intervention, Survey Administration and Interview in people with Lung Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Educational Intervention, Survey Administration and Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 77 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has a documented chest CT within the past one year
- Personal history of lung cancer or symptoms associated with lung cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Matthew Triplette, MD, MPH, 206-667-6335, Mtriplet@fredhutch.org
Matthew Triplette, MD, MPH
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Carcinoma
- Being tested
- Educational Intervention, Survey Administration, Interview, Electronic Health Record Review
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Attend LCS decision-making support session
Survey AdministrationOther
Ancillary studies
InterviewOther
Ancillary studies
Electronic Health Record ReviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Screening [Lung cancer screening (LCS) decision-making support session] | Experimental | Participants attend an in-person restorative justice-based LCS decision-making support session over 2-3 hours on study. Receives: Other: Educational Intervention; Other: Survey Administration; Other: Interview; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: At pre- and post-intervention (both on Day 1)
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 90 days post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Go2 Foundation
- Responsible party
- Sponsor
- Investigators
- Matthew Triplette, MD, MPH, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07490860
- Sponsor's protocol ID
- RG1126204
- Other IDs
- NCI-2026-01261, FHIRB0021187
- Status last verified
- Jun 2026
- First submitted
- 10 Mar 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Restorative Practices to Enhance Shared Decision-Making and Uptake of Lung Cancer Screening in Black Community Members (RESTORE)
- ClinicalTrials.gov ID
- NCT07490860
- Acronym / sponsor ID
- RG1126204
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- AstraZeneca, Go2 Foundation
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening [Lung cancer screening (LCS) decision-making support session] | Experimental | Other: Educational Intervention, Other: Survey Administration, Other: Interview, Other: Electronic Health Record ReviewParticipants attend an in-person restorative justice-based LCS decision-making support session over 2-3 hours on study. |
Who may qualify
- Ages
- 50 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Has a documented chest CT within the past one year
- Personal history of lung cancer or symptoms associated with lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAttend LCS decision-making support session | Other | Screening [Lung cancer screening (LCS) decision-making support session] |
| Survey AdministrationAncillary studies | Other | Screening [Lung cancer screening (LCS) decision-making support session] |
| InterviewAncillary studies | Other | Screening [Lung cancer screening (LCS) decision-making support session] |
| Electronic Health Record ReviewAncillary studies | Other | Screening [Lung cancer screening (LCS) decision-making support session] |
Primary outcome
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).
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Triplette, MD, MPH principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Survey Administration and Interview in people with Lung Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Triplette, MD, MPH (206-667-6335, Mtriplet@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention acceptability (time frame: At post-intervention (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.