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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05784922
Other study ID # 1K08CA270430-01A1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 3, 2023
Est. completion date January 31, 2028

Study information

Verified date March 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this clinical trial is to promote lung cancer screening (LCS) uptake among Hispanic current and former smokers. The main questions it aims to answer are: - What barriers do current and former Hispanic smokers face in the identification and documentation of their smoking status? - How can digital delivery of an educational video promote LCS uptake among current and former Hispanic smokers? Participants will receive an educational video about lung cancer screening and complete brief, self-reported surveys afterwards.


Description:

Lung cancer remains the leading cause of cancer-specific mortality in the US, and Hispanics experience worse lung cancer outcomes and die at higher rates due to advanced stage at presentation. Lung cancer screening (LCS) can save many lives through early lung cancer detection among Hispanic current and former smokers. Still, without increasing efforts to improve smoking status disclosure and documentation and tailored interventions to promote LCS uptake among Hispanic current and former smokers, this underserved population will continue to demonstrate disparities in lung cancer survival. Based on prior research experience, Dr. Flores has adapted the NIMHD research framework by incorporating elements from Ford's evidence-based theoretical model to guide the following proposed study aims: 1) To elucidate barriers and facilitators to consistent identification and documentation of smoking status to promote LCS uptake among Hispanic current and former smokers; 2) To assess feasibility, acceptability, and reach of the digital delivery of an educational video to promote LCS uptake among Hispanic current and former smokers; 3) To explore the effect of the digital delivery of the educational video to increase interest, intent, and scheduling of LCS uptake among Hispanic current and former smokers. Impact: The successful completion of this research will serve as a foundation for developing novel interventions to overcome disparities and advance equity in lung cancer outcomes among Hispanics and other vulnerable populations.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2000
Est. completion date January 31, 2028
Est. primary completion date January 31, 2028
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - Must be 50-80 years old - Are a current or former smoker (quit within 15 years, or a cumulative smoking status of > 20 pack-years) - Not currently enrolled in Lung Cancer Screening - Must speak English or Spanish Exclusion Criteria: - Has a clinical cognitive inability to provide informed consent for participation in the study or complete a brief survey - Currently diagnosed with lung cancer - Currently enrolled in lung cancer screening - Have participated in the focus groups discussions from Aim 1

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Educational Lung Cancer Screening (LCS) Video
An educational video on lung cancer screening tailored to Hispanic current and former smokers.

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Massachusetts General Hospital National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Flores EJ, Park ER, Irwin KE. Improving Lung Cancer Screening Access for Individuals With Serious Mental Illness. J Am Coll Radiol. 2019 Apr;16(4 Pt B):596-600. doi: 10.1016/j.jacr.2018.12.045. — View Citation

Irwin KE, Steffens EB, Yoon Y, Flores EJ, Knight HP, Pirl WF, Freudenreich O, Henderson DC, Park ER. Lung Cancer Screening Eligibility, Risk Perceptions, and Clinician Delivery of Tobacco Cessation Among Patients With Schizophrenia. Psychiatr Serv. 2019 Oct 1;70(10):927-934. doi: 10.1176/appi.ps.201900044. Epub 2019 Jul 30. — View Citation

Narayan AK, Chowdhry DN, Fintelmann FJ, Little BP, Shepard JO, Flores EJ. Racial and Ethnic Disparities in Lung Cancer Screening Eligibility. Radiology. 2021 Dec;301(3):712-720. doi: 10.1148/radiol.2021204691. Epub 2021 Sep 21. — View Citation

Percac-Lima S, Ashburner JM, Atlas SJ, Rigotti NA, Flores EJ, Kuchukhidze S, Park ER. Barriers to and Interest in Lung Cancer Screening Among Latino and Non-Latino Current and Former Smokers. J Immigr Minor Health. 2019 Dec;21(6):1313-1324. doi: 10.1007/s10903-019-00860-2. — View Citation

Wang GX, Neil JM, Fintelmann FJ, Little BP, Narayan AK, Flores EJ. Guideline-Discordant Lung Cancer Screening: Emerging Demand and Provided Indications. J Am Coll Radiol. 2021 Mar;18(3 Pt A):395-405. doi: 10.1016/j.jacr.2020.08.005. Epub 2020 Sep 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Participant baseline smoking status Identify salient participant characteristics obtained from the EHR (e.g., smoking status) among those that interacted with the digital delivery modality. Year 5
Other Participant acceptability of intervention Investigate attributes of the intervention to guide future research and development to create such an intervention (for future trials) Year 5
Primary Participant outreach (contact) of digital link Reach is defined as >20% of enrolled participants interacting with the digital delivery of the LCS educational video (i.e., partial or complete review of the LCS educational video). Year 3
Secondary Participant interaction with digital link Overall proportion of participants that click on the embedded link to the successfully digitally delivered LCS educational videos Year 3
Secondary Participant attention of LCS video Duration of viewing the LCS video (i.e., partial or complete) Year 3
Secondary Survey completion Overall proportion of survey completion by participants. Year 4
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