Lung Cancer
Conditions
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.
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.
Interventions
BEHAVIORALHRHA
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%).
BEHAVIORALLRLA
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%).
BEHAVIORALHRLA
participants will receive High Risk, Low Ancestry (HRLA) hypothetical
BEHAVIORALLRHA
participants will receive Low Risk, High Ancestry (HRLA) hypothetical
Sponsors
National Cancer Institute (NCI)
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motivation to Quit Smoking | 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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%). | 41 |
| 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%). | 40 |
| HRLA High Risk, Low Ancestry
HRLA: participants will receive High Risk, Low Ancestry (HRLA) hypothetical | 43 |
| LRHA Low Risk, High Ancestry
LRHA: participants will receive Low Risk, High Ancestry (HRLA) hypothetical | 42 |
| Total | 166 |
Baseline characteristics
| Characteristic | HRHA | LRLA | HRLA | LRHA | Total |
|---|---|---|---|---|---|
| Age, Continuous | 42.80 Years STANDARD_DEVIATION 13.478 | 43.24 Years STANDARD_DEVIATION 13.821 | 41.58 Years STANDARD_DEVIATION 15.462 | 37.62 Years STANDARD_DEVIATION 14.629 | 41.28 Years STANDARD_DEVIATION 14.428 |
| Race/Ethnicity, Customized African Americans | 41 Participants | 40 Participants | 43 Participants | 42 Participants | 166 Participants |
| Sex: Female, Male Female | 26 Participants | 24 Participants | 25 Participants | 27 Participants | 102 Participants |
| Sex: Female, Male Male | 15 Participants | 16 Participants | 18 Participants | 15 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 41 | 0 / 40 | 0 / 43 | 0 / 42 |
| other Total, other adverse events | 0 / 41 | 0 / 40 | 0 / 43 | 0 / 42 |
| serious Total, serious adverse events | 0 / 41 | 0 / 40 | 0 / 43 | 0 / 42 |
Outcome results
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
Time frame: 1 minute after intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HRHA | Motivation to Quit Smoking | 4.95 units on a scale | Standard Deviation 0.296 |
| LRLA | Motivation to Quit Smoking | 3.30 units on a scale | Standard Deviation 0.254 |
| HRLA | Motivation to Quit Smoking | 5.49 units on a scale | Standard Deviation 0.261 |
| LRHA | Motivation to Quit Smoking | 4.52 units on a scale | Standard Deviation 0.284 |