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Risk Communication in African American Smokers

NCT ID: NCT04084561

Last Updated: 2023-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2022-04-01

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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HRHA

High Risk, High Ancestry

Group Type EXPERIMENTAL

HRHA

Intervention Type BEHAVIORAL

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

Low Risk, Low Ancestry

Group Type EXPERIMENTAL

LRLA

Intervention Type BEHAVIORAL

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

High Risk, Low Ancestry

Group Type EXPERIMENTAL

HRLA

Intervention Type BEHAVIORAL

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

LRHA

Low Risk, High Ancestry

Group Type EXPERIMENTAL

LRHA

Intervention Type BEHAVIORAL

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

Interventions

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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%).

Intervention Type 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%).

Intervention Type BEHAVIORAL

HRLA

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

Intervention Type BEHAVIORAL

LRHA

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age minimum
* Self-report African American
* Report smoking at least 100 lifetime cigarettes

Exclusion Criteria

* Report history of cancer
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Temple University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Camille Ragin, PhD

Role: PRINCIPAL_INVESTIGATOR

Fox Chase Cancer Center

Locations

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Hunter College

New York, New York, United States

Site Status

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1U54CA221705-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-8004

Identifier Type: -

Identifier Source: org_study_id