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| ID | Type | Description | Link |
|---|---|---|---|
| 1U54CA221705-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRHA | Experimental | High Risk, High Ancestry |
|
| LRLA | Experimental | Low Risk, Low Ancestry |
|
| HRLA | Experimental | High Risk, Low Ancestry |
|
| LRHA | Experimental | Low Risk, High Ancestry |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRHA | 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%). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Camille Ragin, PhD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter College | New York | New York | 10065 | United States | ||
| Fox Chase Cancer Center |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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%). |
| FG001 | 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%). |
| FG002 | HRLA | High Risk, Low Ancestry HRLA: participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical |
| FG003 | LRHA | Low Risk, High Ancestry LRHA: participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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%). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | units on a scale | 1 minute after intervention |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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%). |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Grace X. Ma | Center for Asian Health, Temple University | 215-707-6493 | grace.ma@temple.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 20, 2018 | Oct 5, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| LRLA | 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 | Behavioral | participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical |
|
| LRHA | Behavioral | participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical |
|
| Philadelphia |
| Pennsylvania |
| 19111 |
| United States |
| BG001 | 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%). |
| BG002 | HRLA | High Risk, Low Ancestry HRLA: participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical |
| BG003 | LRHA | Low Risk, High Ancestry LRHA: participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | 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%).
| OG002 | HRLA | High Risk, Low Ancestry HRLA: participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical |
| OG003 | LRHA | Low Risk, High Ancestry LRHA: participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical |
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | 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%). | 0 | 40 | 0 | 40 | 0 | 40 |
| EG002 | HRLA | High Risk, Low Ancestry HRLA: participants will receive "High Risk, Low Ancestry (HRLA)" hypothetical | 0 | 43 | 0 | 43 | 0 | 43 |
| EG003 | LRHA | Low Risk, High Ancestry LRHA: participants will receive "Low Risk, High Ancestry (HRLA)" hypothetical | 0 | 42 | 0 | 42 | 0 | 42 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |