RecruitingRecruiting
Genetic Testing Decision Aid
NCT05470920 · Massachusetts General Hospital
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes
About this study
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
Eligibility 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
Study design
Enrollment target: 350 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-10-14
Estimated completion: 2026-12-31
Last updated: 2025-08-13
Interventions
Behavioral: Electronic Decision AidBehavioral: Pre-Test Genetic Counseling
Primary outcomes
- • Average change in knowledge survey score (baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks)
- • Decisional Conflict Scores (1 week after genetics session)
- • Shared Decision Making Process Scores (1 week after genetics session)
Sponsor
Massachusetts General Hospital · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactDaniel C. Chung, MD · contact · Chung.daniel@mgh.harvard.edu · (617) 726-8687
ContactDanielle A Lynch, BS · contact · dlynch22@mgh.harvard.edu · (617) 726-1355
InvestigatorDaniel C. Chung, MD · principal_investigator, Massachusetts General Hospital
All locations (2)
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Mass General at North Shore Cancer CenterRecruiting
Danvers, Massachusetts, United States