Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
Primary Purpose
Genetic Testing
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Survey of Decision Aid
Sponsored by
About this trial
This is an interventional health services research trial for Genetic Testing focused on measuring Decision Aid
Eligibility Criteria
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
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Electronic Decision Aid
Arm Description
Participants in this arm will complete an electronic decision aid for genetic testing.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Total time spent on decision aid
The total amount of minutes spent on the decision aid
Full Information
NCT ID
NCT04704193
First Posted
January 7, 2021
Last Updated
January 13, 2023
Sponsor
Massachusetts General Hospital
Collaborators
Boston Medical Center, National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT04704193
Brief Title
Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
Official Title
Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Boston Medical Center, National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genetic Testing
Keywords
Decision Aid
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electronic Decision Aid
Arm Type
Experimental
Arm Description
Participants in this arm will complete an electronic decision aid for genetic testing.
Intervention Type
Other
Intervention Name(s)
Survey of Decision Aid
Intervention Description
The decision aid will be evaluated by a survey administered to those who have used the tool.
Primary Outcome Measure Information:
Title
Participant satisfaction with how educational information is presented in the decision aid
Description
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
Secondary Outcome Measure Information:
Title
Total time spent on decision aid
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel C Chung, MD
Phone
6177263544
Email
chung.daniel@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Lynch
Phone
6177261355
Email
DLYNCH22@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel C Chung, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Chung, MD
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
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