An interventional study of HRHA and LRLA in Lung Cancer, sponsored by Temple University. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by Temple University · Not applicable, Interventional, and Prevention
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.
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.
7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's enrollment of 166 is above the median of 60 across 5,345 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Temple University is the lead sponsor of 223 studies on the registry; 29 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 7 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
High Risk, High Ancestry
Behavioral: HRHA
Low Risk, Low Ancestry
Behavioral: LRLA
High Risk, Low Ancestry
Behavioral: HRLA
Low Risk, High Ancestry
Behavioral: LRHA
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%).
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%).
participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical
participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical
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
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.
| Milestone | HRHA | LRLA | HRLA | LRHA |
|---|---|---|---|---|
| Started | 41 | 40 | 43 | 42 |
| Completed | 41 | 40 | 43 | 42 |
| Not completed | 0 | 0 | 0 | 0 |
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
| units on a scale | HRHA | LRLA | HRLA | LRHA |
|---|---|---|---|---|
| Motivation to Quit Smoking | 4.95 ± .296 | 3.30 ± .254 | 5.49 ± .261 | 4.52 ± .284 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| HRHA | 0/41 (0%) | 0/41 (0%) | 0/41 (0%) |
| LRLA | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| HRLA | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
| LRHA | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Age, Continuous(Years) | HRHA | LRLA | HRLA | LRHA | Total |
|---|---|---|---|---|---|
| Mean | 42.80 ± 13.478 | 43.24 ± 13.821 | 41.58 ± 15.462 | 37.62 ± 14.629 | 41.28 ± 14.428 |
| Sex: Female, Male(Participants) | HRHA | LRLA | HRLA | LRHA | Total |
|---|---|---|---|---|---|
| Female | 26 | 24 | 25 | 27 | 102 |
| Male | 15 | 16 | 18 | 15 | 64 |
| Race/Ethnicity, Customized(Participants) | HRHA | LRLA | HRLA | LRHA | Total |
|---|---|---|---|---|---|
| African Americans | 41 | 40 | 43 | 42 | 166 |
Documents are hosted by the registry — open the source record to download them.
Ran from Sep 2018 to primary completion in Apr 2022, 43 months.
Results were first posted in Dec 2023, 1 year 8 months after primary completion.
Of 774 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 71. This study's 43 months is close to that.
Counting every sponsor, half of 818 studies reached it within 39 months; a quarter within 17 and three quarters within 71.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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