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NCT Number: NCT07615764

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location contact

Matthew Triplette, MD, MPH

PRINCIPAL_INVESTIGATOR

Nicolas Anderson

CONTACT

[email protected]

206-667-5434

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Receive Lung Toolkit materials

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

interview

Other

Ancillary studies

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicolas Anderson

CONTACT

[email protected]

206.667.5434

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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