Genetic TestingNCT04704193
Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
A study testing Survey of Decision Aid in people with Genetic Testing, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetic Testing
- What is being tested?
- Survey of Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (18 years of age or older)
- Diagnosed with malignant ovarian tumor or malignant pancreatic adenocarcinoma
Who cannot join
- Children (<18 years of age)
- Unable to complete surveys
- Previous germline genetic testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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.
- Conditions
- Genetic Testing
- Being tested
- Survey of Decision Aid
- Keywords
- Decision Aid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey of Decision AidOther
The decision aid will be evaluated by a survey administered to those who have used the tool.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Decision Aid | Experimental | Participants in this arm will complete an electronic decision aid for genetic testing. Receives: Other: Survey of Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: This outcome will be measured immediately following completion of the decision aid. The average completion time of the decision aid is 14 minutes.
Secondary outcomes (1)
Total Time Spent on Decision Aid
The total amount of minutes spent on the decision aid
Measured: From the start of the decision aid to the completion of the decision aid
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study start20 Nov 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Genetic TestingStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Daniel C Chung, Massachusetts General Hospital
- Investigators
- Daniel C Chung, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704193
- Sponsor's protocol ID
- 2020P003422
- Other IDs
- U01CA243695-01
- Status last verified
- Jul 2024
- First submitted
- 7 Jan 2021
- Last updated
- 13 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
- ClinicalTrials.gov ID
- NCT04704193
- Acronym / sponsor ID
- 2020P003422
- Conditions
- Genetic Testing
- Keywords
- Decision Aid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Boston Medical Center, National Cancer Institute (NCI)
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 11 Jan 2021 (actual)
- Results
- Posted 13 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electronic Decision Aid | Experimental | Other: Survey of Decision AidParticipants in this arm will complete an electronic decision aid for genetic testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (18 years of age or older)
- Diagnosed with malignant ovarian tumor or malignant pancreatic adenocarcinoma
Key exclusion criteria (3 listed)
- Children (<18 years of age)
- Unable to complete surveys
- Previous germline genetic testing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey of Decision AidThe decision aid will be evaluated by a survey administered to those who have used the tool. | Other | Electronic Decision Aid |
Primary outcome
Participant Satisfaction With How Educational Information is Presented in the Decision Aid
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.
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.
1 secondary outcome
Total Time Spent on Decision Aid
Time frame: From the start of the decision aid to the completion of the decision aid
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel C Chung, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey of Decision Aid in people with Genetic Testing, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Satisfaction With How Educational Information is Presented in the Decision Aid (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2024.