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

NCT07615764 | Not Yet Recruiting

• 2 other identifiers: RG1126249NCI-2026-03253
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Carcinoma

Outcome Measures

Primary Outcomes (2)

• Acceptability of intervention

  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

  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 Outcomes (5)

• User engagement

  During 30-day use period

• User behavior

  During 30-day use period

• Medical mistrust

  From baseline to day 45

• Perceived smoking-related stigma

  From baseline to day 45

• Self-efficacy for lung cancer screening

  From baseline to day 45

Study Arms (1)

Prevention (Lung Toolkit)

EXPERIMENTAL

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: Educational Intervention; Other: Interview; Other: Questionnaire Administration

Interventions

Educational Intervention OTHER

Receive Lung Toolkit materials

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Prevention (Lung Toolkit)

Interview OTHER

Ancillary studies

Prevention (Lung Toolkit)

Questionnaire Administration OTHER

Ancillary studies

Prevention (Lung Toolkit)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: collaborator
• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Interviews as Topic

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Matthew Triplette, MD, MPH

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Anderson

CONTACT

206.667.5434; nanders3@fredhutch.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 29, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)