Back to resultsRisk Communication in African American Smokers
Primary Purpose
Lung Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HRHA
LRLA
HRLA
LRHA
Sponsored by
About this trial
This is an interventional prevention trial for Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- 18 years of age minimum
- Self-report African American
- Report smoking at least 100 lifetime cigarettes
Exclusion Criteria:
- Report history of cancer
Sites / Locations
- Hunter College
- Fox Chase Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
HRHA
LRLA
HRLA
LRHA
Arm Description
High Risk, High Ancestry
Low Risk, Low Ancestry
High Risk, Low Ancestry
Low Risk, High Ancestry
Outcomes
Primary Outcome Measures
Motivation to Quit Smoking
use self report 7 item (condition options) MTSS (Motivation to Stop Smoking) Scale with yes/no option to determine the quitting intention condition
Secondary Outcome Measures
Full Information
NCT ID
NCT04084561
First Posted
September 6, 2019
Last Updated
June 22, 2022
Sponsor
Temple University
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04084561
Brief Title
Risk Communication in African American Smokers
Official Title
Nicotine Dependence and Lung Cancer Genetics in African Americans
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Temple University
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aims to understand the effects of learning about one's genetic risk for lung cancer that is specific to their ancestry. Participants will be given hypothetical personalized genetic risk results and ask to think about how they might respond to such information if they actually received such results.
Detailed Description
The study aims to understand the effects of learning about one's genetic risk for lung cancer that is specific to their ancestry. Smokers will be randomized to receive hypothetical information about their genetic status and consider how they think they would respond if such results were actually presented to them. They will be randomly assigned to receive one of four sets of hypothetical genetic results: 1) High risk of lung cancer and high genetic African ancestry, 2) High risk of lung cancer and low genetic African ancestry, 3) Low risk of lung cancer and high genetic African ancestry, or 4) Low risk of lung cancer and low genetic African ancestry. After being given this hypothetical information, participants will complete brief questionnaires assessing perceived risk of lung cancer, worry about cancer, psychological distress, and motivation to quit smoking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
394 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HRHA
Arm Type
Experimental
Arm Description
High Risk, High Ancestry
Arm Title
LRLA
Arm Type
Experimental
Arm Description
Low Risk, Low Ancestry
Arm Title
HRLA
Arm Type
Experimental
Arm Description
High Risk, Low Ancestry
Arm Title
LRHA
Arm Type
Experimental
Arm Description
Low Risk, High Ancestry
Intervention Type
Behavioral
Intervention Name(s)
HRHA
Intervention Description
participants will be asked to consider a hypothetical scenario in which genetic test results reveal that: 1) they carry genotypes that place African American smokers at a particularly high (~50%-80%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly high concordance with African heritage (~90%).
Intervention Type
Behavioral
Intervention Name(s)
LRLA
Intervention Description
participants will be asked to consider a scenario in which genetic test results reveal that: 1) they are at normal (~7%-10%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly low concordance with African heritage (~10%).
Intervention Type
Behavioral
Intervention Name(s)
HRLA
Intervention Description
participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical
Intervention Type
Behavioral
Intervention Name(s)
LRHA
Intervention Description
participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical
Primary Outcome Measure Information:
Title
Motivation to Quit Smoking
Description
use self report 7 item (condition options) MTSS (Motivation to Stop Smoking) Scale with yes/no option to determine the quitting intention condition
Time Frame
immediately following intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years of age minimum
Self-report African American
Report smoking at least 100 lifetime cigarettes
Exclusion Criteria:
Report history of cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille Ragin, PhD
Organizational Affiliation
Fox Chase Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunter College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Risk Communication in African American Smokers
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