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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

28. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Fred Hutch/University of Washington Cancer Consortium
        • Ledende efterforsker:
          • Matthew Triplette, MD, MPH
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Andet: Spørgeskemaadministration
Hjælpestudier
Andet: Interview
Hjælpestudier
Andet: Educational Intervention
Receive Lung Toolkit materials
Andre navne:
  • Uddannelse til intervention
  • Intervention af uddannelse
  • Intervention gennem uddannelse
  • Intervention, pædagogisk
Andet: Educational Intervention
Receive guided review of Lung Toolkit materials
Andre navne:
  • Uddannelse til intervention
  • Intervention af uddannelse
  • Intervention gennem uddannelse
  • Intervention, pædagogisk

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acceptability of intervention
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
User engagement
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Fred Hutchinson Cancer Center

Samarbejdspartnere

Bristol-Myers Squibb

Efterforskere

  • Ledende efterforsker: Matthew Triplette, MD, MPH, Fred Hutch/University of Washington Cancer Consortium

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. november 2026

Primær færdiggørelse (Anslået)

31. marts 2027

Studieafslutning (Anslået)

31. maj 2027

Datoer for studieregistrering

Først indsendt

11. maj 2026

Først indsendt, der opfyldte QC-kriterier

28. maj 2026

Først opslået (Faktiske)

29. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

29. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

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