Actively Recruiting
Randomized Controlled Trial of an Electronic Decision Aid Versus Genetic Counselor for Multi-Gene Panel Testing in Inherited Cancer Syndromes
Led by Massachusetts General Hospital · Updated on 2025-08-13
350
Participants Needed
2
Research Sites
13 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of an electronic decision aid tool compared to traditional genetic counselor sessions for multi-gene panel testing in people diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma. This randomized study is supported by the National Cancer Institute and aims to help patients better understand genetic testing options and support shared decision making. Participants are randomly assigned to one of two groups: one group uses the electronic decision aid followed by an appointment with their oncologist, while the other receives pretest counseling from a genetic counselor. Both groups complete several questionnaires including a Knowledge Survey, Shared Decision Making Process Survey, and Decisional Conflict Scale. The study duration is up to two weeks. During the study, participants complete surveys before and about one week after their genetics sessions to assess knowledge, decision conflict, and shared decision making. Researchers also track the time between genetic testing recommendation and sample collection, the duration of the decision-making process, and choices made regarding genetic testing panels. Approximately 350 people are expected to participate in this research.
CONDITIONS
Brief Title
Genetic Testing Decision Aid
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Up to 2 weeks
Participants receive either an electronic decision aid followed by an appointment with their oncologist or pre-test counseling with a genetic counselor. They complete study questionnaires including knowledge surveys and decision-making assessments.
1 to 2 visits depending on assigned intervention
Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Mass General at North Shore Cancer Center
Danvers, Massachusetts, United States, 01923
Actively Recruiting
Research Team
D
Daniel C. Chung, MD
D
Danielle A Lynch, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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