Lung CarcinomaNCT07615764
An Educational Intervention (Lung Toolkit) for Improving Knowledge About Lung Cancer and Screening Among American Indian and Alaskan Native Cigarette Smokers, Lung PATHS Trial
A study testing Educational Intervention, Interview and Questionnaire Administration in people with Lung Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Carcinoma
- What is being tested?
- Educational Intervention, Interview and Questionnaire Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Nicolas Anderson, 206-667-5434, nanders3@fredhutch.org
Matthew Triplette, MD, MPH
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Carcinoma
- Being tested
- Educational Intervention, Interview, Questionnaire Administration
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive Lung Toolkit materials
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Receive guided review of Lung Toolkit materials
InterviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational Intervention; Other: Interview; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to day 45
Secondary outcomes (5)
User engagement
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).
Measured: During 30-day use period
User behavior
Participant behavior, and how participants navigate the website will be measured through click tracking (tracking of where users click on a website).
Measured: During 30-day use period
Medical mistrust
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.
Measured: From baseline to day 45
Perceived smoking-related stigma
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.
Measured: From baseline to day 45
Self-efficacy for lung cancer screening
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.
Measured: From baseline to day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Matthew Triplette, MD, MPH, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615764
- Sponsor's protocol ID
- RG1126249
- Other IDs
- NCI-2026-03253, FHIRB0021313
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Health Promotion for AI/AN People Through Human Center Design (Lung PATHS) - Aim 3 Intervention
- ClinicalTrials.gov ID
- NCT07615764
- Acronym / sponsor ID
- RG1126249
- Conditions
- Lung Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prevention (Lung Toolkit) | Experimental | Other: Educational Intervention, Other: Interview, Other: Questionnaire AdministrationParticipants 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 may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive Lung Toolkit materials | Other | Prevention (Lung Toolkit) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalReceive guided review of Lung Toolkit materials | Other | Prevention (Lung Toolkit) |
| InterviewAncillary studies | Other | Prevention (Lung Toolkit) |
| Questionnaire AdministrationAncillary studies | Other | Prevention (Lung Toolkit) |
Primary outcome
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.
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.
5 secondary outcomes
User engagement
Time frame: During 30-day use period
User behavior
Time frame: During 30-day use period
Medical mistrust
Time frame: From baseline to day 45
Perceived smoking-related stigma
Time frame: From baseline to day 45
Self-efficacy for lung cancer screening
Time frame: From baseline to day 45
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Triplette, MD, MPH principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Interview and Questionnaire Administration in people with Lung Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicolas Anderson (206.667.5434, nanders3@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of intervention (time frame: At post-guided review assessment (day 15) and post-intervention (day 45)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.