Lung Carcinoma
Conditions
Brief 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. 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
OTHEREducational Intervention
Attend LCS decision-making support session
OTHERSurvey Administration
Ancillary studies
OTHERInterview
Ancillary studies
OTHERElectronic Health Record Review
Ancillary studies
Sponsors
Fred Hutchinson Cancer Center
AstraZeneca
Go2 Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 77 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intervention acceptability | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Readiness to screen | 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. |
| Medical mistrust | 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. |
| Perceived smoking-related stigma | 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. |
| Shared decision-making (SDM) process | 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. |
| Completion of chest computed tomography (CT) | Up to 90 days post-intervention | Will assess completion of chest CT within 90 days post-intervention with no comparison. |
| Intervention acceptability and refinement | 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. |
Countries
United States
Contacts
CONTACTMatthew Triplette, MD, MPH
PRINCIPAL_INVESTIGATORMatthew Triplette, MD, MPH
Fred Hutch/University of Washington Cancer Consortium
Outcome results
None listed