- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05784922
Health Opportunities and Promoters of Equitable Screening for Lung Cancer (HOPES)
Health Opportunities and Promoters of Equitable Screening for Lung Cancer (HOPES for Lung Cancer)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Efren Flores, MD
- Phone Number: 617-724-4254
- Email: ejflores@mgh.harvard.edu
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Elyse Park, PhD
- Phone Number: 617-724-7792
- Email: epark@mgh.harvard.edu
-
Principal Investigator:
- Efren Flores, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Digital Outreach: Patient Gateway
Participants who list "Patient Gateway" as the preferred mode of contact in the electronic health record (EHR) system.
Patient Gateway is an online patient portal that gives patients access to securely message their Mass General Brigham provider, request routine appointments, prescriptions and referral authorizations as well as view test results that were processed at a Mass General Brigham facility.
Participants will receive the digital educational lung cancer screening video via their patient gateway account.
|
An educational video on lung cancer screening tailored to Hispanic current and former smokers.
|
|
Digital Outreach: Text
Participants who list "Text" as the preferred mode of contact in the electronic health record (EHR) system.
Participants will receive the digital educational lung cancer screening video via a text message sent directly to their cell phone.
|
An educational video on lung cancer screening tailored to Hispanic current and former smokers.
|
|
Digital Outreach: Email
Participants who list "Email" as the preferred mode of contact in the electronic health record (EHR) system.
Participants will receive the digital educational lung cancer screening video directly to the email they have listed.
|
An educational video on lung cancer screening tailored to Hispanic current and former smokers.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant outreach (contact) of digital link
Time Frame: Year 3
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant interaction with digital link
Time Frame: Year 3
|
Overall proportion of participants that click on the embedded link to the successfully digitally delivered LCS educational videos
|
Year 3
|
|
Participant attention of LCS video
Time Frame: Year 3
|
Duration of viewing the LCS video (i.e., partial or complete)
|
Year 3
|
|
Survey completion
Time Frame: Year 4
|
Overall proportion of survey completion by participants.
|
Year 4
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant baseline smoking status
Time Frame: Year 5
|
Identify salient participant characteristics obtained from the EHR (e.g., smoking status) among those that interacted with the digital delivery modality.
|
Year 5
|
|
Participant acceptability of intervention
Time Frame: Year 5
|
Investigate attributes of the intervention to guide future research and development to create such an intervention (for future trials)
|
Year 5
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Efren Flores, MD, Massachusetts General Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Pathological Conditions, Signs and Symptoms
- Behavior
- Lung Neoplasms
- Disease
- Smoking
- Technology, Industry, and Agriculture
- Technology
- Tape Recording
- Audiovisual Aids
- Educational Technology
- Television
- Videotape Recording
Other Study ID Numbers
- 1K08CA270430-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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