An interventional study of Survey of Decision Aid in Genetic Testing, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-13.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research
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.
Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) 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:
Participants in this arm will complete an electronic decision aid for genetic testing.
Other: 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
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.
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
| Milestone | Electronic Decision Aid |
|---|---|
| Started | 93 |
| Completed | 92 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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.
| Participants | Electronic Decision Aid |
|---|---|
| Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk — Rating: Poor | 1 |
| Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk — Rating: Fair | 3 |
| Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk — Rating: Good | 29 |
| Genetic testing is a blood test that looks for mutations in genes that can increase cancer risk — Rating: Excellent | 55 |
| Genetic test results may help guide my treatment options — Rating: Poor | 2 |
| Genetic test results may help guide my treatment options — Rating: Fair | 4 |
| Genetic test results may help guide my treatment options — Rating: Good | 30 |
| Genetic test results may help guide my treatment options — Rating: Excellent | 51 |
| Genetic test results may help me understand the future risks of other cancers — Rating: Poor | 1 |
| Genetic test results may help me understand the future risks of other cancers — Rating: Fair | 4 |
| Genetic test results may help me understand the future risks of other cancers — Rating: Good | 26 |
| Genetic test results may help me understand the future risks of other cancers — Rating: Excellent | 57 |
| Genetic test results may increase stress to me and my family members — Rating: Poor | 5 |
| Genetic test results may increase stress to me and my family members — Rating: Fair | 8 |
| Genetic test results may increase stress to me and my family members — Rating: Good | 33 |
| Genetic test results may increase stress to me and my family members — Rating: Excellent | 41 |
| There are 3 gene panel options that include either a small, medium, or large number of genes — Rating: Poor | 2 |
| There are 3 gene panel options that include either a small, medium, or large number of genes — Rating: Fair | 4 |
| There are 3 gene panel options that include either a small, medium, or large number of genes — Rating: Good | 31 |
| There are 3 gene panel options that include either a small, medium, or large number of genes — Rating: Excellent | 50 |
| Gene test results may come back as positive, negative, or uncertain — Rating: Poor | 1 |
| Gene test results may come back as positive, negative, or uncertain — Rating: Fair | 6 |
| Gene test results may come back as positive, negative, or uncertain — Rating: Good | 33 |
| Gene test results may come back as positive, negative, or uncertain — Rating: Excellent | 46 |
The total amount of minutes spent on the decision aid
| minutes | Electronic Decision Aid |
|---|---|
| Total Time Spent on Decision Aid | 13.7 ± 5.6 |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Electronic Decision Aid | 0/92 (0%) | 0/92 (0%) | 0/92 (0%) |
Of the 93 participants, only 92 participants completed the study. Only the information from the 92 participants is included in the baseline characteristics analysis because one participant withdrew from the study.
| Age, Categorical(Participants) | Electronic Decision Aid |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 45 |
| >=65 years | 47 |
| Age, Continuous(years) | Electronic Decision Aid |
|---|---|
| Mean | 64.75 ± 12.53 |
| Sex: Female, Male(Participants) | Electronic Decision Aid |
|---|---|
| Female | 65 |
| Male | 27 |
| Race (NIH/OMB)(Participants) | Electronic Decision Aid |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 3 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 80 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Nov 2020 to primary completion in Dec 2023, 37 months.
Results were first posted in Aug 2024, 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital →