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An Educational Intervention (Lung Toolkit) for Improving Knowledge About Lung Cancer and Screening Among American Indian and Alaskan Native Cigarette Smokers, Lung PATHS Trial

Lung Health Promotion for AI/AN People Through Human Center Design (Lung PATHS) - Aim 3 Intervention

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07615764
Enrollment
60
Registered
2026-05-29
Start date
2026-11-01
Completion date
2027-05-31
Last updated
2026-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Carcinoma

Brief summary

This clinical trial evaluates the acceptability and effectiveness of an educational intervention (Lung Toolkit) for improving knowledge about lung cancer and lung cancer screening among American Indian/Alaskan Native (AI/AN) cigarette smokers. The Lung Toolkit is an educational intervention, including a website and a physical artifact pouch, specifically tailored to the needs of AI/AN individuals. The website includes evidence-based resources about lung health and lung cancer screening, facts about commercial tobacco and traditional tobacco, national and local smoking cessation and screening resources, and community-building resources such as stories from AI/AN community members about their experiences with lung cancer screening and smoking cessation. The physical artifact pouch links to the website with a quick response code and contains ceremonial herbs and motivational messaging around smoking cessation and lung cancer screening. The Lung Toolkit intervention may be effective for improving knowledge about lung cancer and lung cancer screening among AI/AN cigarette smokers.

Detailed description

OUTLINE: Participants receive the Lung Toolkit materials, including a link to the lung health toolkit website and a physical artifact pouch, and then receive a guided review of the Lung Toolkit materials over 60 minutes. Following the guided review, participants use the Lung Toolkit materials for 30 days.

Interventions

OTHEREducational Intervention

Receive Lung Toolkit materials

OTHERInterview

Ancillary studies

OTHERQuestionnaire Administration

Ancillary studies

Sponsors

Fred Hutchinson Cancer Center
Lead SponsorOTHER
Bristol-Myers Squibb
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Between ages 50-80 * Self-identify as AI/AN * Self-reported 10 pack-year smoking history (commercial tobacco i.e. cigarettes) * Ability to understand and willingness to sign an informed consent document

Exclusion criteria

* Not between ages 50-80 * Having less than a 10 pack-year history of smoking commercial tobacco * Inability to communicate in written and verbal English * Having any cognitive impairment that compromises the ability to provide informed consent

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of interventionAt post-guided review assessment (day 15) and post-intervention (day 45)Acceptability will be evaluated using the Acceptability of Intervention (AIM) assessment score and semi-structured interviews. AIM results will be summarized and presented as a range of score from 1 to 5.
Lung cancer screening knowledgeFrom baseline to day 45Will be evaluated using a validated measure for assessing lung cancer screening knowledge (Lung Cancer Screening Knowledge Score \[LKS\]-7). Pre- and post-intervention LKS responses will be compared via Cochran-Mantel-Haenszel and Friedman tests.

Secondary

MeasureTime frameDescription
User engagementDuring 30-day use periodThe effectiveness of the website in terms of engagement will be measured by tracking of bounce rate (percentage of visitors who land on website homepage and leave immediately without taking any further action, or viewing other pages).
User behaviorDuring 30-day use periodParticipant behavior, and how participants navigate the website will be measured through click tracking (tracking of where users click on a website).
Medical mistrustFrom baseline to day 45The intervention efficacy potential to mitigate medical mistrust will be evaluated using validated measures of discrimination and medical mistrust (Discrimination in Medical Settings; Group-Based Medical Mistrust Scale). Participant responses for each scale will be summarized with the median and range of scores at pre- and post-intervention.
Perceived smoking-related stigmaFrom baseline to day 45The intervention efficacy potential to reduce perceived smoking-related stigma will be evaluated using a validated measure of perceived smoking-related stigma (Cataldo Lung Cancer Stigma Scale, smoking-related subscale). Participant responses for each scale will be summarized with the median and range of scores at pre- and post-intervention.
Self-efficacy for lung cancer screeningFrom baseline to day 45The intervention efficacy potential to improve self-efficacy for lung cancer screening will be evaluated using a validated 9-item measure assessing self-efficacy for lung cancer screening. Participant responses for each scale will be summarized with the median and range of scores at pre- and post-intervention.

Countries

United States

Contacts

CONTACTNicolas Anderson
nanders3@fredhutch.org206.667.5434
PRINCIPAL_INVESTIGATORMatthew Triplette, MD, MPH

Fred Hutch/University of Washington Cancer Consortium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 30, 2026