- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06010355
Culturally Tailored Educational Video to Promote Lung Cancer Screening in Vulnerable Communities
Breathe Easier, Philadelphia! Engaging Vulnerable Communities for Innovative Lung Cancer Care
Study Overview
Status
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVES:
I. To understand barriers and opportunities for engaging three culturally distinct populations in lung cancer screening.
II. To develop three culturally tailored educational videos about lung cancer and the benefits of lung cancer screening.
III. To test the impact of the videos on susceptibility to lung cancer, knowledge of lung cancer screening, and intentions to undergo lung cancer screening in a diverse sample of at-risk individuals.
OUTLINE: Participants are assigned to 1 of 3 arms.
ARM I (AIM 1): Participants participate in a focus group over 1 hour in support of the development of a culturally tailored educational video on study.
ARM II (AIM 2): Participants watch a culturally tailored educational video over 3-5 minutes and then immediately undergo an interview in support of the refinement of a culturally tailored educational video on study.
ARM III (AIM 3): Participants watch a culturally tailored educational video over 3-5 minutes and complete a brief test pre- and post-video over 30 minutes on study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- AIM 1: Participants must be African American, Korean, or Chinese adults who have either: a history of smoking, a history of lung cancer, or who have undergone lung cancer screening
- AIM 2: Participants must be African American, Korean, or Chinese adults who have either: a history of smoking, a history of lung cancer, or who have undergone lung cancer screening
- AIM 3: Those who are African American, Korean or Chinese, and are eligible for lung cancer screening, based on current screening guidelines: Current or former smokers who are between 50 and 80 years of age and who have smoked at least one pack a day for 20 years or two packs a day for 10 years
Exclusion Criteria:
- AIM 1: Those excluded from participating include children; those who are not members of the African American, Chinese, or Korean community; those who do not have one of the following: a history of smoking, a history of lung cancer, or have undergone lung cancer screening
- AIM 2: Those excluded from participating include children; those who are not members of the African American, Chinese, or Korean community; those who do not have one of the following: a history of smoking, a history of lung cancer, or have undergone lung cancer screening
- AIM 3: Those excluded from participating include children; those who are not members of the African American, Chinese, or Korean community; those who do not have a history of smoking; those who have been diagnosed with lung cancer; those who have undergone lung cancer screening in the past
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I (Aim 1) (focus group)
Participants participate in a focus group over 1 hour in support of the development of a culturally tailored educational video on study.
|
Participate in focus groups
Other Names:
|
|
Experimental: Arm II (Aim 2) (video, interview)
Participants watch a culturally tailored educational video over 3-5 minutes and then immediately undergo an interview in support of the refinement of a culturally tailored educational video on study.
|
Undergo interview
Watch culturally appropriate video
|
|
Experimental: Arm III (Aim 3) (video, test)
Participants watch a culturally tailored educational video over 3-5 minutes and complete a brief test pre- and post-video over 30 minutes on study.
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Watch culturally appropriate video
Complete test
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To understand barriers and opportunities for engaging three culturally distinct populations in lung cancer screening.
Time Frame: From baseline to endpoint, up to 1 year
|
Participants will be asked about their awareness of lung cancer screening, known or perceived barriers to screening, and potential opportunities or initiatives that could increase lung cancer screening rates in their community.
Discussions will be audio recorded, transcribed by a professional transcription company, and analyzed by the study team using qualitative research methods.
|
From baseline to endpoint, up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To develop three culturally tailored educational videos about lung cancer and the benefits of lung cancer screening
Time Frame: From baseline to endpoint, up to 1 year
|
Ethnic cultural or other differences will be assessed and highlighted within each group, based on results from the focus groups.
The beta versions of each video will be pre-tested among a small sample of individuals in each target population to refine and confirm the approach.
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From baseline to endpoint, up to 1 year
|
|
To test the impact of the videos on susceptibility to lung cancer, knowledge of lung cancer screening, and intentions to undergo lung cancer screening in a diverse sample of at-risk individuals.
Time Frame: From baseline to endpoint, up to 1 year
|
First, participants will complete a brief pre-test measuring their susceptibility to lung cancer, their knowledge about lung cancer screening, their intentions to undergo lung cancer screening, and sociodemographic characteristics. Next, they will watch the video that was designed for their culture. Lastly, they will complete a post-test that includes the same measures as the pre-test, plus some additional metrics on the quality and satisfaction with the video. The statistical analyses will focus on describing the sociodemographic characteristics, health behaviors, and health history of participants and testing their pre-post responses for the effects of the video intervention to address Aim 3. Descriptive statistics for continuous or ordinal (e.g., Likert) scaled study variables will include means with standard deviations (or medians with first and third quartiles for skewed data) and for discrete study variables will include frequency counts with percentages. |
From baseline to endpoint, up to 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amy R Leader, DrPH, MPH, Thomas Jefferson University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Health Care Quality, Access, and Evaluation
- Investigative Techniques
- Epidemiologic Methods
- Data Collection
- Health Care Evaluation Mechanisms
- Quality of Health Care
- Public Health
- Environment and Public Health
- Interviews as Topic
Other Study ID Numbers
- iRISID-2022-1320
- JT 25584 (Other Identifier: JeffTrial Number)
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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