Evaluating a digital tool for genetic testing decisions in cancer patients
Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes
This study is testing whether a digital tool can help people with ovarian or pancreatic cancer make better decisions about genetic testing compared to regular counseling.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT05470920 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of an electronic decision aid compared to traditional genetic counseling for patients with ovarian or pancreatic cancer considering multi-gene panel testing. Participants will complete eligibility screenings and questionnaires assessing their knowledge, decision-making process, and any conflicts regarding their choices. The study will last up to two weeks and aims to enroll approximately 350 individuals. Funded by the National Cancer Institute, this trial is conducted at Massachusetts General Hospital and Boston Medical Center.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma who are being seen at the participating clinics.
Not a fit: Patients who have previously undergone germline genetic testing or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient understanding and decision-making regarding genetic testing for cancer, potentially leading to better personalized treatment options.
How similar studies have performed: Other studies have shown promise in using digital decision aids for medical decision-making, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / 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
Where this trial is running
Boston, Massachusetts and 1 other locations
- Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)
- Mass General at North Shore Cancer Center — Danvers, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Daniel C. Chung, MD — Massachusetts General Hospital
- Study coordinator: Daniel C. Chung, MD
- Email: Chung.daniel@mgh.harvard.edu
- Phone: (617) 726-8687
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.