Trial Outcomes & Findings for Risk Communication in African American Smokers (NCT NCT04084561)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

166 participants

Primary outcome timeframe

1 minute after intervention

Results posted on

2023-12-18

Participant Flow

Because of COVID, and with the consent of the funding agency and IRB, we opened a second IRB to JUST do Aim 3. So Aim 3 is independent and it is the only part that was a clinical trial. This sample consisted of 166 respondents.

Aim3 was the clinical trial component. We were initially informed by clinical trials staff that we should include enrollment numbers for ALL of the aims. Then we were informed to include only those recruited to Aim 3. Although the original goal was to recruit participants from Aims 1 and 2 to do Aim 3, COVID-19 made that impossible. Thus, with consent of the funding agency and IRB, we pivoted to collect the Aim 3 data remotely in an independent sample. This sample consisted of 166 respondents.

Participant milestones

Participant milestones
Measure	HRHA High Risk, High Ancestry 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 Low Risk, Low Ancestry 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 High Risk, Low Ancestry HRLA: participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical	LRHA Low Risk, High Ancestry LRHA: participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical
Overall Study STARTED	41	40	43	42
Overall Study COMPLETED	41	40	43	42
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Risk Communication in African American Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HRHA n=41 Participants High Risk, High Ancestry 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 n=40 Participants Low Risk, Low Ancestry 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 n=43 Participants High Risk, Low Ancestry HRLA: participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical	LRHA n=42 Participants Low Risk, High Ancestry LRHA: participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical	Total n=166 Participants Total of all reporting groups
Age, Continuous	42.80 Years STANDARD_DEVIATION 13.478 • n=5 Participants	43.24 Years STANDARD_DEVIATION 13.821 • n=7 Participants	41.58 Years STANDARD_DEVIATION 15.462 • n=5 Participants	37.62 Years STANDARD_DEVIATION 14.629 • n=4 Participants	41.28 Years STANDARD_DEVIATION 14.428 • n=21 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	24 Participants n=7 Participants	25 Participants n=5 Participants	27 Participants n=4 Participants	102 Participants n=21 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	16 Participants n=7 Participants	18 Participants n=5 Participants	15 Participants n=4 Participants	64 Participants n=21 Participants
Race/Ethnicity, Customized African Americans	41 Participants n=5 Participants	40 Participants n=7 Participants	43 Participants n=5 Participants	42 Participants n=4 Participants	166 Participants n=21 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	HRHA n=41 Participants High Risk, High Ancestry 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 n=40 Participants Low Risk, Low Ancestry 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 n=43 Participants High Risk, Low Ancestry HRLA: participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical	LRHA n=42 Participants Low Risk, High Ancestry LRHA: participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical
Motivation to Quit Smoking	4.95 units on a scale Standard Deviation .296	3.30 units on a scale Standard Deviation .254	5.49 units on a scale Standard Deviation .261	4.52 units on a scale Standard Deviation .284

Adverse Events

HRHA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LRLA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HRLA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LRHA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Grace X. Ma

Center for Asian Health, Temple University

Phone: 215-707-6493

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place