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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-77
SponsorFred Hutchinson Cancer Center

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Has a documented chest CT within the past one year

Personal history of lung cancer or symptoms associated with lung cancer

Trial design

Design model

Single group

Treatments tested in this trial

  • Educational Intervention

    Other intervention

    Attend LCS decision-making support session

  • Survey Administration

    Other intervention

    Ancillary studies

  • Interview

    Other intervention

    Ancillary studies

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Screening [Lung cancer screening (LCS) decision-making support session]Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
At post-intervention (Day 1)
2

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.

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

Secondary outcomes

1

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.

Time frame
At pre- and post-intervention (both on Day 1)
2

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.

Time frame
At pre- and post-intervention (both on Day 1)
3

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.

Time frame
At pre- and post-intervention (both on Day 1)
4

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.

Time frame
At post-intervention (Day 1)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

AstraZeneca

Collaborator

Go2 Foundation

Collaborator