Trial Outcomes & Findings for Clinical Validity and Utility of Genomic-targeted Chemoprevention of PCa: Aim 4a (NCT NCT02381015)
NCT ID: NCT02381015
Last Updated: 2019-11-22
Results Overview
Discussion with Physician regarding PSA screening, measured by survey 3 months after provision of risk information
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
700 participants
Primary outcome timeframe
3 months
Results posted on
2019-11-22
Participant Flow
Participant milestones
| Measure |
Genetic Risk Score: Number Format
Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.
Genetic Risk Score: Number Format: Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.
|
Genetic Risk Score: Number + Pictograph
Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.
Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number Format
Family History: Number Format Subjects receive family history risk in a number format.
Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number + Pictograph
Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.
Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
|---|---|---|---|---|
|
Year 3 Chart Review
NOT COMPLETED
|
47
|
34
|
58
|
51
|
|
Visit 1 - Enrollment
STARTED
|
175
|
175
|
175
|
175
|
|
Visit 1 - Enrollment
COMPLETED
|
175
|
173
|
175
|
172
|
|
Visit 1 - Enrollment
NOT COMPLETED
|
0
|
2
|
0
|
3
|
|
Visit 2 - Results DIsclosure
STARTED
|
175
|
173
|
175
|
172
|
|
Visit 2 - Results DIsclosure
COMPLETED
|
172
|
168
|
173
|
169
|
|
Visit 2 - Results DIsclosure
NOT COMPLETED
|
3
|
5
|
2
|
3
|
|
Visit 3 - 3 Months Followup
STARTED
|
172
|
168
|
173
|
169
|
|
Visit 3 - 3 Months Followup
COMPLETED
|
172
|
168
|
173
|
169
|
|
Visit 3 - 3 Months Followup
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Year 3 Chart Review
STARTED
|
172
|
168
|
173
|
169
|
|
Year 3 Chart Review
COMPLETED
|
125
|
134
|
115
|
118
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Validity and Utility of Genomic-targeted Chemoprevention of PCa: Aim 4a
Baseline characteristics by cohort
| Measure |
Genetic Risk Score: Number Format
n=175 Participants
Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.
Genetic Risk Score: Number Format: Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.
|
Genetic Risk Score: Number + Pictograph
n=175 Participants
Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.
Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number Format
n=175 Participants
Family History: Number Format Subjects receive family history risk in a number format.
Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number + Pictograph
n=175 Participants
Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.
Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Total
n=700 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.9 years
STANDARD_DEVIATION 2.85 • n=5 Participants
|
44.8 years
STANDARD_DEVIATION 3.06 • n=7 Participants
|
44.7 years
STANDARD_DEVIATION 2.84 • n=5 Participants
|
45.0 years
STANDARD_DEVIATION 2.76 • n=4 Participants
|
44.85 years
STANDARD_DEVIATION 2.88 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
175 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
700 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
175 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
700 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
175 participants
n=5 Participants
|
175 participants
n=7 Participants
|
175 participants
n=5 Participants
|
175 participants
n=4 Participants
|
700 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 monthsDiscussion with Physician regarding PSA screening, measured by survey 3 months after provision of risk information
Outcome measures
| Measure |
Genetic Risk Score: Number Format
n=175 Participants
Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.
Genetic Risk Score: Number Format: Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.
|
Genetic Risk Score: Number + Pictograph
n=173 Participants
Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.
Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number Format
n=175 Participants
Family History: Number Format Subjects receive family history risk in a number format.
Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number + Pictograph
n=172 Participants
Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.
Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
|---|---|---|---|---|
|
Number of Participants Who Had Prostate Specific Antigen (PSA) Discussion With Physician at 3 Months, Measured by Survey
|
34 participants
|
30 participants
|
25 participants
|
22 participants
|
PRIMARY outcome
Timeframe: 3 monthsPSA screening, measured by survey 3 months after provision of risk information.
Outcome measures
| Measure |
Genetic Risk Score: Number Format
n=172 Participants
Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.
Genetic Risk Score: Number Format: Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.
|
Genetic Risk Score: Number + Pictograph
n=168 Participants
Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.
Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number Format
n=173 Participants
Family History: Number Format Subjects receive family history risk in a number format.
Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number + Pictograph
n=169 Participants
Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.
Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
|---|---|---|---|---|
|
Number of Participants Who Had PSA Testing at 3 Months, Measured by Survey
|
8 participants
|
7 participants
|
4 participants
|
3 participants
|
PRIMARY outcome
Timeframe: 3 yearsPSA screening, measured by medical records 3 years after provision of risk information.
Outcome measures
| Measure |
Genetic Risk Score: Number Format
n=125 Participants
Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.
Genetic Risk Score: Number Format: Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.
|
Genetic Risk Score: Number + Pictograph
n=134 Participants
Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.
Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number Format
n=115 Participants
Family History: Number Format Subjects receive family history risk in a number format.
Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number + Pictograph
n=118 Participants
Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.
Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
|---|---|---|---|---|
|
Number of Participants Who Had PSA Testing at 3 Years, Measured by Medical Records
|
45 participants
|
46 participants
|
29 participants
|
40 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Computerized randomization of 700 study identifiers into 175 blocks of four each was completed prior to enrollment. Genetic Risk Score=GRS and Family History=FH. Randomization groups were (Group 1) GRS+FH as a number; (Group 2) GRS+FH as a number and pictograph; (Group 3) FH as a number; and (Group 4) FH as a number and pictograph.
Immediate reaction to risk information. Measured by state anxiety scale that assess current feelings "at this moment": 1) not at all, 2) somewhat, 3) moderately so, and 4) very much so. A shortened version of questions 1,3,5,9,11,12,13,15,17, and 19 from STAI form XI were used. Each item, within then STAI is scored on a scale of 1-4 and with 10 items, the possible range of total scores was 10 (lowest anxiety) to 40 (highest anxiety). Lowest scores represent better outcomes.
Outcome measures
| Measure |
Genetic Risk Score: Number Format
n=175 Participants
Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.
Genetic Risk Score: Number Format: Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.
|
Genetic Risk Score: Number + Pictograph
n=172 Participants
Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.
Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number Format
n=174 Participants
Family History: Number Format Subjects receive family history risk in a number format.
Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number + Pictograph
n=171 Participants
Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.
Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
|---|---|---|---|---|
|
Anxiety, Measured by State-trait Anxiety Inventory (STAI)
|
15.25 units on a scale
Standard Deviation 4.43
|
15.95 units on a scale
Standard Deviation 5.19
|
14.92 units on a scale
Standard Deviation 4.40
|
15.12 units on a scale
Standard Deviation 3.93
|
SECONDARY outcome
Timeframe: BaselineMean between Immediate recall of risk information and told risk information. Immediate recall is measured by survey question: "Based on the information given to you, what were you told is your chance of developing prostate cancer in your lifetime from 0% to 100% \_\_\_\_\_\_ %"
Outcome measures
| Measure |
Genetic Risk Score: Number Format
n=175 Participants
Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.
Genetic Risk Score: Number Format: Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.
|
Genetic Risk Score: Number + Pictograph
n=173 Participants
Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.
Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number Format
n=174 Participants
Family History: Number Format Subjects receive family history risk in a number format.
Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number + Pictograph
n=173 Participants
Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.
Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
|---|---|---|---|---|
|
Accuracy of Immediate Recall of Risk Information Measured by Survey
|
0.65 Percentage of recall
Standard Deviation 4.05
|
0.72 Percentage of recall
Standard Deviation 3.84
|
0.26 Percentage of recall
Standard Deviation 1.42
|
1.0 Percentage of recall
Standard Deviation 5.84
|
SECONDARY outcome
Timeframe: 3 monthMean between recall of risk information at 3 months measured by survey, and told risk information. Recall at 3 months is measured by survey question: "Based on the information given to you, what were you told is your chance of developing prostate cancer in your lifetime from 0% to 100% \_\_\_\_\_\_ %"
Outcome measures
| Measure |
Genetic Risk Score: Number Format
n=172 Participants
Genetic Risk Score: Number Format Subjects receive genetic risk scores in a number format.
Genetic Risk Score: Number Format: Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.
|
Genetic Risk Score: Number + Pictograph
n=168 Participants
Genetic Risk Score: Number + Pictograph Subjects receive genetic risk scores in a number and pictograph format.
Genetic Risk Score: Number + Pictograph: Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number Format
n=173 Participants
Family History: Number Format Subjects receive family history risk in a number format.
Family History: Number Format: Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
Family History: Number + Pictograph
n=169 Participants
Family History: Number + Pictograph Subjects receive family history risk in a number and pictograph format.
Family History: Number + Pictograph: Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
|
|---|---|---|---|---|
|
Accuracy of Recall of Risk Information at 3 Months Measured by Survey
|
3.30 Percentage of recall
Standard Deviation 6.04
|
3.78 Percentage of recall
Standard Deviation 6.01
|
4.43 Percentage of recall
Standard Deviation 6.92
|
4.38 Percentage of recall
Standard Deviation 7.33
|
Adverse Events
Genetic Risk Score: Number Format
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Genetic Risk Score: Number + Pictograph
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Family History: Number Format
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Family History: Number + Pictograph
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. Aubrey R. Turner
Wake Forest University Health Sciences
Phone: 336-918-3585
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place