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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04084561
Other study ID # 18-8004
Secondary ID 1U54CA221705-01A
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date April 1, 2022

Study information

Verified date November 2023
Source Temple University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 166
Est. completion date April 1, 2022
Est. primary completion date April 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
HRHA
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%).
LRLA
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%).
HRLA
participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical
LRHA
participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical

Locations

Country Name City State
United States Hunter College New York New York
United States Fox Chase Cancer Center Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
Temple University National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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; range of scale : 1-7, with higher score means higher motivation to quit smoking 1 minute after intervention
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