- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04084561
Risk Communication in African American Smokers
November 27, 2023 updated by: Temple University
Nicotine Dependence and Lung Cancer Genetics in African Americans
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
166
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Hunter College
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19111
- Fox Chase Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years of age minimum
- Self-report African American
- Report smoking at least 100 lifetime cigarettes
Exclusion Criteria:
- Report history of cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HRHA
High Risk, High Ancestry
|
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%).
|
Experimental: LRLA
Low Risk, Low Ancestry
|
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%).
|
Experimental: HRLA
High Risk, Low Ancestry
|
participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical
|
Experimental: LRHA
Low Risk, High Ancestry
|
participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivation to Quit Smoking
Time Frame: 1 minute after intervention
|
use self report 7 item (condition options) MTSS (Motivation to Stop Smoking) Scale with yes/no option to determine the quitting intention condition; range of scale : 1-7, with higher score means higher motivation to quit smoking
|
1 minute after intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Camille Ragin, PhD, Fox Chase Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
April 1, 2022
Study Completion (Actual)
April 1, 2022
Study Registration Dates
First Submitted
September 6, 2019
First Submitted That Met QC Criteria
September 6, 2019
First Posted (Actual)
September 10, 2019
Study Record Updates
Last Update Posted (Actual)
December 18, 2023
Last Update Submitted That Met QC Criteria
November 27, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-8004
- 1U54CA221705-01A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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