Genetic Testing
Conditions
Keywords
Decision Aid
Brief summary
An electronic decision aid will be used to assist individuals in choosing a multi-gene panel with their medical oncologist instead of a genetic counselor. A decision aid may facilitate quality decisions around the selection of a specific multi-gene panel without a genetic counselor. Upon completion of the decision aid, participants will be asked to indicate their decision about whether to pursue genetic testing and which specific multi-gene panel to pursue. A survey will then be administered to assess participants' opinions on the decision aid.
Interventions
OTHERSurvey of Decision Aid
The decision aid will be evaluated by a survey administered to those who have used the tool.
Sponsors
Boston Medical Center
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults (18 years of age or older) * Diagnosed with malignant ovarian tumor or malignant pancreatic adenocarcinoma
Exclusion criteria
* Children (\<18 years of age) * Unable to complete surveys * Previous germline genetic testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Satisfaction With How Educational Information is Presented in the Decision Aid | This outcome will be measured immediately following completion of the decision aid. The average completion time of the decision aid is 14 minutes. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Time Spent on Decision Aid | From the start of the decision aid to the completion of the decision aid | The total amount of minutes spent on the decision aid |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 92 |
| Total | 92 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Electronic Decision Aid |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 47 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Age, Continuous | 64.75 years STANDARD_DEVIATION 12.53 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 80 Participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 92 |
| other Total, other adverse events | 0 / 92 |
| serious Total, serious adverse events | 0 / 92 |
Outcome results
Primary
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
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.
Time frame: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
| Electronic Decision Aid | 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 |
Comparison: Descriptive statistics only/proportion reported good or excellent~Q1a. Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk95% CI: [0.888, 0.987]
Comparison: Descriptive statistics only/proportion reported good or excellent~Q1b. Genetic test results may help guide my treatment options95% CI: [0.856, 0.974]
Comparison: Descriptive statistics only/proportion reported good or excellent~Q1c. Genetic test results may help me understand the future risks of other cancers95% CI: [0.872, 0.981]
Comparison: Descriptive statistics only/proportion reported good or excellent~Q1d. Genetic test results may increase stress to me and my family members95% CI: [0.758, 0.918]
Comparison: Descriptive statistics only/proportion reported good or excellent~Q1e. There are 3 gene panel options that include either a small, medium, or large number of genes95% CI: [0.856, 0.974]
Comparison: Descriptive statistics only/proportion reported good or excellent~Q1f. Gene test results may come back as positive, negative or uncertain95% CI: [0.839, 0.967]
Secondary
Total Time Spent on Decision Aid
The total amount of minutes spent on the decision aid
Time frame: From the start of the decision aid to the completion of the decision aid
Population: There were 85 participants who completed the Electronic Decision Aid tool.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electronic Decision Aid | Total Time Spent on Decision Aid | 13.7 minutes | Standard Deviation 5.6 |