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

NCT ID: NCT04704193

Last Updated: 2024-08-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Genetic Testing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Electronic Decision Aid

Participants in this arm will complete an electronic decision aid for genetic testing.

Group Type EXPERIMENTAL

Survey of Decision Aid

Intervention Type OTHER

The decision aid will be evaluated by a survey administered to those who have used the tool.

Interventions

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Survey of Decision Aid

The decision aid will be evaluated by a survey administered to those who have used the tool.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Medical Center

OTHER

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Daniel C Chung

Daniel C Chung, MD; Director, High-Risk GI Cancer Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel C Chung, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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U01CA243695-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2020P003422

Identifier Type: -

Identifier Source: org_study_id

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