Genetic Testing Decision Aid

NCT ID: NCT05470920

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-14

Study Completion Date

2026-12-31

Brief Summary

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This is a randomized trial to evaluate the effectiveness of an electronic decision aid tool versus a traditional genetic counselor session for multi-gene panel testing for people with ovarian or pancreatic cancer

Detailed Description

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The research study procedures include: screening for eligibility and study questionnaires that would be performed in conjunction with either the genetic counselor visit or use of the electronic decision aid. The study questionnaires include:

* Knowledge Survey
* Shared Decision Making Process Survey
* Decisional Conflict Scale

The research study will last up to 2 weeks. It is expected that about 350 people will take part in this research study.

The National Cancer Institute (NCI) is supporting this research study by providing funding for the research

Conditions

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Epithelial Ovarian Carcinoma Pancreas Adenocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Electronic decision aid arm

Receive decision aid followed by an appointment with their oncologist.

Group Type EXPERIMENTAL

Electronic Decision Aid

Intervention Type BEHAVIORAL

Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires

Genetic counselor Arm

Receive pretest counseling with a genetic counselor.

Group Type ACTIVE_COMPARATOR

Pre-Test Genetic Counseling

Intervention Type BEHAVIORAL

Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires

Interventions

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Electronic Decision Aid

Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires

Intervention Type BEHAVIORAL

Pre-Test Genetic Counseling

Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* Being seen in clinic at Massachusetts General Hospital or Boston Medical Center
* Diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma.

Exclusion Criteria

* Unable or unwilling to provide informed consent, undergo randomization, or complete the surveys associated with the study
* Previous germline genetic testing
* History of hereditary pancreatitis
* Members of the following vulnerable populations: adults unable to consent, individuals who are not yet adults
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Daniel C Chung

Principal Investigator

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 RECRUITING

Mass General at North Shore Cancer Center

Danvers, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Daniel C. Chung, MD

Role: CONTACT

(617) 726-8687

Danielle A Lynch, BS

Role: CONTACT

(617) 726-1355

Facility Contacts

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Daniel C. Chung, MD

Role: primary

(617) 726-8687

Sara Bouberhan, MD

Role: primary

Other Identifiers

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U01CA243695

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-155

Identifier Type: -

Identifier Source: org_study_id

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