NCT04084561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 6, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

December 18, 2023

Completed
Last Updated

December 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3.6 years

First QC Date

September 6, 2019

Results QC Date

May 3, 2023

Last Update Submit

November 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

HRHA

EXPERIMENTAL

High Risk, High Ancestry

Behavioral: HRHA

LRLA

EXPERIMENTAL

Low Risk, Low Ancestry

Behavioral: LRLA

HRLA

EXPERIMENTAL

High Risk, Low Ancestry

Behavioral: HRLA

LRHA

EXPERIMENTAL

Low Risk, High Ancestry

Behavioral: LRHA

Interventions

HRHABEHAVIORAL

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%).

HRHA
LRLABEHAVIORAL

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%).

LRLA
HRLABEHAVIORAL

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

HRLA
LRHABEHAVIORAL

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

LRHA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Report history of cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hunter College

New York, New York, 10065, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Limitations and Caveats

This study examined the effects of communicating hypothetical genetic results to patients on their motivation to quit smoking. Future research needs to study effects of actual genetic risk communication, and its effects on actual smoking cessation behavior, rather than motivation to quit. Nevertheless the results suggest communicating elevated risk of lung cancer may increase motivation to quit smoking.

Results Point of Contact

Title
Dr. Grace X. Ma
Organization
Center for Asian Health, Temple University

Study Officials

  • Camille Ragin, PhD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2019

First Posted

September 10, 2019

Study Start

September 1, 2018

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

December 18, 2023

Results First Posted

December 18, 2023

Record last verified: 2023-11

Locations