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

May 28, 2026 updated by: Fred Hutchinson Cancer Center

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium
        • Principal Investigator:
          • Matthew Triplette, MD, MPH
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prevention (Lung Toolkit)
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.
Other: Questionnaire Administration
Ancillary studies
Other: Interview
Ancillary studies
Other: Educational Intervention
Receive Lung Toolkit materials
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational
Other: Educational Intervention
Receive guided review of Lung Toolkit materials
Other Names:
  • Education for Intervention
  • Intervention by Education
  • Intervention through Education
  • Intervention, Educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of intervention
Time Frame: At 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.
At post-guided review assessment (day 15) and post-intervention (day 45)
Lung cancer screening knowledge
Time Frame: From baseline to day 45
Will 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.
From baseline to day 45

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
User engagement
Time Frame: During 30-day use period
The 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).
During 30-day use period
User behavior
Time Frame: During 30-day use period
Participant behavior, and how participants navigate the website will be measured through click tracking (tracking of where users click on a website).
During 30-day use period
Medical mistrust
Time Frame: From baseline to day 45
The 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.
From baseline to day 45
Perceived smoking-related stigma
Time Frame: From baseline to day 45
The 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.
From baseline to day 45
Self-efficacy for lung cancer screening
Time Frame: From baseline to day 45
The 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.
From baseline to day 45

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Matthew Triplette, MD, MPH, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

May 11, 2026

First Submitted That Met QC Criteria

May 28, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1126249
  • NCI-2026-03253 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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