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| ID | Type | Description | Link |
|---|---|---|---|
| U01CA243695-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Boston Medical Center | OTHER |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic Decision Aid | Experimental | Participants in this arm will complete an electronic decision aid for genetic testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey of Decision Aid | Other | The decision aid will be evaluated by a survey administered to those who have used the tool. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | This outcome will be measured immediately following completion of the decision aid. The average completion time of the decision aid is 14 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Time Spent on Decision Aid | The total amount of minutes spent on the decision aid | From the start of the decision aid to the completion of the decision aid |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel C Chung, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | This outcome will be measured immediately following completion of the decision aid. The average completion time of the decision aid is 14 minutes. |
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1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Chung, MD | Massachusetts General Hospital | 617-726-8687 | chung.daniel@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 3, 2022 | Jun 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2024 | Jul 18, 2024 | SAP_001.pdf |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Total Time Spent on Decision Aid | The total amount of minutes spent on the decision aid | There were 85 participants who completed the Electronic Decision Aid tool. | Posted | Mean | Standard Deviation | minutes | From the start of the decision aid to the completion of the decision aid |
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| 0 |
| 92 |
| 0 |
| 92 |
| 0 |
| 92 |
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| Rating: Excellent |
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| Rating: Excellent |
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| Rating: Excellent |
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| Rating: Excellent |
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| Rating: Excellent |
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