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NCT04704193 Clinical Trial

Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes

Genetic Testing Clinical Trial

Official title:
Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04704193
Other study ID # 2020P003422
Secondary ID U01CA243695-01
Status Completed
Phase N/A
First received
Last updated
Start date November 20, 2020
Est. completion date December 31, 2023

Study information
Verified date March 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Survey of Decision Aid
The decision aid will be evaluated by a survey administered to those who have used the tool.

Locations
Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (3)
Lead Sponsor Collaborator
Massachusetts General Hospital Boston Medical Center, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
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. This outcome will be measured immediately following completion of the decision aid
Secondary 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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