Back to resultsCulturally Tailored Educational Video to Promote Lung Cancer Screening in Vulnerable Communities
Primary Purpose
Cigarette Smoking-Related Carcinoma, Lung Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Discussion
Media Intervention
Interview
Media Intervention
Test
Sponsored by
About this trial
This is an interventional screening trial for Cigarette Smoking-Related Carcinoma
Eligibility Criteria
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
Sites / Locations
- Thomas Jefferson University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm I (Aim 1) (focus group)
Arm II (Aim 2) (video, interview)
Arm III (Aim 3) (video, test)
Arm Description
Participants participate in a focus group over 1 hour in support of the development of a culturally tailored educational video on study.
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.
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.
Outcomes
Primary Outcome Measures
Change in knowledge about lung cancer screening
McNemar's test and 95% confidence intervals (CI) used to compare the post-video knowledge response (single multiple choice correct/incorrect item) to the pre-video baseline knowledge response. Generalized estimating equations (GEE) linear and logistic regression models with main effect and interaction terms constructed to explore the potential effect modification between the video intervention and cultural subgroups.
Secondary Outcome Measures
Change in perceptions of susceptibility to lung cancer
Paired t-tests and 95% CI used to compare the post-video perceived susceptibility scores (scored from four 4-point Likert scaled items to pre-video baseline scores. GEE linear and logistic regression models with main effect and interaction terms constructed to explore the potential effect modification between the video intervention and cultural subgroups.
Change in intention to undergo lung cancer screening
Paired t-tests and 95% CI used to compare the post-video intention to screen score (single 4-point Likert scaled item) to pre-video baseline scores. GEE linear and logistic regression models with main effect and interaction terms constructed to explore the potential effect modification between the video intervention and cultural subgroups.
Full Information
NCT ID
NCT06010355
First Posted
August 18, 2023
Last Updated
August 18, 2023
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT06010355
Brief Title
Culturally Tailored Educational Video to Promote Lung Cancer Screening in Vulnerable Communities
Official Title
Breathe Easier, Philadelphia! Engaging Vulnerable Communities for Innovative Lung Cancer Care
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This clinical trial evaluates the impact of a culturally tailored educational video on the perceptions of lung cancer and lung cancer screening in vulnerable communities. Lung cancer is the most common cancer type. African-American communities have a higher rate than any other racial or ethnic group in the United States and accounts for the highest number of deaths among African-Americans. Lung cancer is in the top three causes of cancer death among Asian men and women. Research has shown that low-income, minority and immigrant individuals may be under resourced to make decisions about prevention programs and early detection measures for lung cancer. A culturally tailored educational video may be an effective method to help people learn about lung cancer, susceptibility toward lung cancer and lung cancer screening. This may increase lung cancer screening in vulnerable communities.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking-Related Carcinoma, Lung Carcinoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm I (Aim 1) (focus group)
Arm Type
Experimental
Arm Description
Participants participate in a focus group over 1 hour in support of the development of a culturally tailored educational video on study.
Arm Title
Arm II (Aim 2) (video, interview)
Arm Type
Experimental
Arm Description
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 Title
Arm III (Aim 3) (video, test)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Discussion
Other Intervention Name(s)
Discuss
Intervention Description
Participate in focus groups
Intervention Type
Other
Intervention Name(s)
Media Intervention
Intervention Description
Watch culturally appropriate video
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Undergo interview
Intervention Type
Other
Intervention Name(s)
Media Intervention
Intervention Description
Watch culturally appropriate video
Intervention Type
Other
Intervention Name(s)
Test
Intervention Description
Complete test
Primary Outcome Measure Information:
Title
Change in knowledge about lung cancer screening
Description
McNemar's test and 95% confidence intervals (CI) used to compare the post-video knowledge response (single multiple choice correct/incorrect item) to the pre-video baseline knowledge response. Generalized estimating equations (GEE) linear and logistic regression models with main effect and interaction terms constructed to explore the potential effect modification between the video intervention and cultural subgroups.
Time Frame
From baseline to endpoint, up to 1 year
Secondary Outcome Measure Information:
Title
Change in perceptions of susceptibility to lung cancer
Description
Paired t-tests and 95% CI used to compare the post-video perceived susceptibility scores (scored from four 4-point Likert scaled items to pre-video baseline scores. GEE linear and logistic regression models with main effect and interaction terms constructed to explore the potential effect modification between the video intervention and cultural subgroups.
Time Frame
From baseline to endpoint, up to 1 year
Title
Change in intention to undergo lung cancer screening
Description
Paired t-tests and 95% CI used to compare the post-video intention to screen score (single 4-point Likert scaled item) to pre-video baseline scores. GEE linear and logistic regression models with main effect and interaction terms constructed to explore the potential effect modification between the video intervention and cultural subgroups.
Time Frame
From baseline to endpoint, up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Leader, DrPH, MPH
Phone
215-955-7739
Email
Amy.Leader@jefferson.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy R Leader, DrPH, MPH
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Leader, DrPH, MPH
12. IPD Sharing Statement
Learn more about this trial
Culturally Tailored Educational Video to Promote Lung Cancer Screening in Vulnerable Communities
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