Trial Outcomes & Findings for Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes (NCT NCT04704193)
NCT ID: NCT04704193
Last Updated: 2024-08-13
Results Overview
Measured with 6 items on a questionnaire that asks participants to rate the way certain information is presented on the decision aid. Each item is rated on a scale of 1 to 4, with 1 being poor and 4 being excellent.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
93 participants
Primary outcome timeframe
This outcome will be measured immediately following completion of the decision aid. The average completion time of the decision aid is 14 minutes.
Results posted on
2024-08-13
Participant Flow
Participant milestones
| Measure |
Electronic Decision Aid
Participants in this arm will complete an electronic decision aid for genetic testing.
Survey of Decision Aid: The decision aid will be evaluated by a survey administered to those who have used the tool.
|
|---|---|
|
Overall Study
STARTED
|
93
|
|
Overall Study
COMPLETED
|
92
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Electronic Decision Aid
Participants in this arm will complete an electronic decision aid for genetic testing.
Survey of Decision Aid: The decision aid will be evaluated by a survey administered to those who have used the tool.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
Baseline characteristics by cohort
| Measure |
Electronic Decision Aid
n=92 Participants
Participants in this arm will complete an electronic decision aid for genetic testing.
Survey of Decision Aid: The decision aid will be evaluated by a survey administered to those who have used the tool.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
47 Participants
n=5 Participants
|
|
Age, Continuous
|
64.75 years
STANDARD_DEVIATION 12.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: This outcome will be measured immediately following completion of the decision aid. The average completion time of the decision aid is 14 minutes.Population: A total of 88 participants agreed to complete this survey. For questions 1b, 1d, and 1e there are only 87 complete answer choices. For question 1f, there are only 86 complete answer choices.
Measured with 6 items on a questionnaire that asks participants to rate the way certain information is presented on the decision aid. Each item is rated on a scale of 1 to 4, with 1 being poor and 4 being excellent.
Outcome measures
| Measure |
Electronic Decision Aid
n=88 Participants
Participants in this arm will complete an electronic decision aid for genetic testing.
Survey of Decision Aid: The decision aid will be evaluated by a survey administered to those who have used the tool.
|
|---|---|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk · Rating: Poor
|
1 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk · Rating: Fair
|
3 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk · Rating: Good
|
29 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk · Rating: Excellent
|
55 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic test results may help guide my treatment options · Rating: Poor
|
2 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic test results may help guide my treatment options · Rating: Fair
|
4 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic test results may help guide my treatment options · Rating: Good
|
30 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic test results may help guide my treatment options · Rating: Excellent
|
51 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic test results may help me understand the future risks of other cancers · Rating: Poor
|
1 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic test results may help me understand the future risks of other cancers · Rating: Fair
|
4 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic test results may help me understand the future risks of other cancers · Rating: Good
|
26 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic test results may help me understand the future risks of other cancers · Rating: Excellent
|
57 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic test results may increase stress to me and my family members · Rating: Poor
|
5 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic test results may increase stress to me and my family members · Rating: Fair
|
8 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic test results may increase stress to me and my family members · Rating: Good
|
33 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Genetic test results may increase stress to me and my family members · Rating: Excellent
|
41 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
There are 3 gene panel options that include either a small, medium, or large number of genes · Rating: Poor
|
2 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
There are 3 gene panel options that include either a small, medium, or large number of genes · Rating: Fair
|
4 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
There are 3 gene panel options that include either a small, medium, or large number of genes · Rating: Good
|
31 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
There are 3 gene panel options that include either a small, medium, or large number of genes · Rating: Excellent
|
50 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Gene test results may come back as positive, negative, or uncertain · Rating: Poor
|
1 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Gene test results may come back as positive, negative, or uncertain · Rating: Fair
|
6 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Gene test results may come back as positive, negative, or uncertain · Rating: Good
|
33 Participants
|
|
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
Gene test results may come back as positive, negative, or uncertain · Rating: Excellent
|
46 Participants
|
SECONDARY outcome
Timeframe: From the start of the decision aid to the completion of the decision aidPopulation: There were 85 participants who completed the Electronic Decision Aid tool.
The total amount of minutes spent on the decision aid
Outcome measures
| Measure |
Electronic Decision Aid
n=85 Participants
Participants in this arm will complete an electronic decision aid for genetic testing.
Survey of Decision Aid: The decision aid will be evaluated by a survey administered to those who have used the tool.
|
|---|---|
|
Total Time Spent on Decision Aid
|
13.7 minutes
Standard Deviation 5.6
|
Adverse Events
Electronic Decision Aid
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place