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Risk Communication in African American Smokers

Sponsor
Temple University (Other)
Overall Status
Completed
CT.gov ID
NCT04084561
Collaborator
National Cancer Institute (NCI) (NIH)
394
Enrollment
2
Locations
4
Arms
43
Actual Duration (Months)
197
Patients Per Site
4.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: HRHA
  • Behavioral: LRLA
  • Behavioral: HRLA
  • Behavioral: LRHA
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
394 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Nicotine Dependence and Lung Cancer Genetics in African Americans
Actual Study Start Date :
Sep 1, 2018
Actual Primary Completion Date :
Apr 1, 2022
Actual Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: HRHA

High Risk, High Ancestry

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%).
Experimental: LRLA

Low Risk, Low Ancestry

Behavioral: 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%).
Experimental: HRLA

High Risk, Low Ancestry

Behavioral: HRLA
participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical
Experimental: LRHA

Low Risk, High Ancestry

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

Outcome Measures

Primary Outcome Measures

  1. Motivation to Quit Smoking [immediately following intervention]

    use self report 7 item (condition options) MTSS (Motivation to Stop Smoking) Scale with yes/no option to determine the quitting intention condition

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 18 years of age minimum

  • Self-report African American

  • Report smoking at least 100 lifetime cigarettes

Exclusion Criteria:
  • Report history of cancer

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hunter College New York New York United States 10065
2 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111

Sponsors and Collaborators

  • Temple University
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Camille Ragin, PhD, Fox Chase Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Temple University
ClinicalTrials.gov Identifier:
NCT04084561
Other Study ID Numbers:
  • 18-8004
  • 1U54CA221705-01A1
First Posted:
Sep 10, 2019
Last Update Posted:
Jun 24, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Lung Neoplasms

Study Results

No Results Posted as of Jun 24, 2022