NCT05470920 · Massachusetts General Hospital
Genetic Testing Decision Aid
What this study is about
This is a randomly assigned 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
View original scientific description
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
Interventions
BEHAVIORAL
Electronic Decision Aid
Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires
BEHAVIORAL
Pre-Test Genetic Counseling
Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires
Primary outcome measures
Average change in knowledge survey score
Time frame: baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks
Average change in score on a 10-question knowledge survey to assess basic information about genetics and genetic testing that was covered in their appointment. Scores on the scale range from 0-10. Higher values in the change in knowledge survey score suggest greater amount of knowledge gained in the genetics session.
Decisional Conflict Scores
Time frame: 1 week after genetics session
The decisional conflict score is a score ranging from 0-100 that is measured from a 10-question validated decisional conflict scale. The scale assesses participant's confidence in their decision with higher scores indicating higher decisional conflict.
Shared Decision Making Process Scores
Time frame: 1 week after genetics session
The shared decision making process score is a score on a scale of 1-4 based on responses on a validated 4-item shared-decision making scale. The scale assesses how well the decision aid/oncology provider, or the genetic counselor engaged in shared decision-making as perceived by the subject. Higher scores on this scale indicate more shared decision making.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
- Danvers, Massachusetts
Collaborators
National Cancer Institute (NCI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2025 · Source of record for eligibility and locations