Genetic Testing Decision Aid

Mass General Brigham

Status: Enrolling

Conditions: Pancreas Adenocarcinoma; Epithelial Ovarian Carcinoma

Treatments: Behavioral: Electronic Decision Aid; Behavioral: Pre-Test Genetic Counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05470920

22-155

U01CA243695 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full description

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

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Electronic decision aid arm

Experimental group

Description:

Receive decision aid followed by an appointment with their oncologist.

Treatment:

Behavioral: Electronic Decision Aid

Genetic counselor Arm

Active Comparator group

Description:

Receive pretest counseling with a genetic counselor.

Treatment:

Behavioral: Pre-Test Genetic Counseling