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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04704193
Recruitment Status : Recruiting
First Posted : January 11, 2021
Last Update Posted : January 11, 2021
Sponsor:
Collaborators:
Boston Medical Center
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Daniel C Chung, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Genetic Testing Other: Survey of Decision Aid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Development and Implementation of Electronic Decision Aids for Genetic Testing in Inherited Cancer Syndromes
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arm Intervention/treatment
Experimental: Electronic Decision Aid
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.




Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Total time spent on decision aid [ Time Frame: From the start of the decision aid to the completion of the decision aid ]
    The total amount of minutes spent on the decision aid



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04704193


Contacts
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Contact: Daniel C Chung, MD 6177263544 chung.daniel@mgh.harvard.edu
Contact: Ava Siegel 6177261355 asiegel2@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Daniel Chung, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Boston Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Daniel C Chung, MD Massachusetts General Hospital
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Responsible Party: Daniel C Chung, Daniel C Chung, MD; Director, High-Risk GI Cancer Clinic, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT04704193    
Other Study ID Numbers: 2020P003422
U01CA243695-01 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2021    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel C Chung, Massachusetts General Hospital:
Decision Aid
Additional relevant MeSH terms:
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Neoplastic Syndromes, Hereditary
Neoplasms
Genetic Diseases, Inborn