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An Electronic Decision Aid Compared to Traditional Genetic Counseling for Genetic Testing Decision-Making in Ovarian or Pancreatic Cancer
Trial Status: active
This clinical trial compares the use of an electronic decision aide to traditional genetic counseling for genetic testing decision-making in patients with ovarian or pancreatic cancer. Studying the genes in a patient's tumor cells may help doctors improve ways to diagnose and treat patients with ovarian or prostate cancer. Barriers such as lack of testing referrals, limited number of genetic counselors, and oncologists’ lack of time or expertise can prevent cancer patients' ability to receive genetic testing. The use of an electronic decision aid along with a visit with an oncology provider may assist patients in deciding on and receiving genetic testing similar to those who receive genetic counseling.
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 (infants, children, teenagers), pregnant women, prisoners
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05470920.
I. To evaluate the effectiveness of an electronic decision aid tool versus a traditional genetic counselor session for multi-gene panel testing.
II. To evaluate the hypothesis that an electronic decision aid in conjunction with a visit with an oncology provider promotes levels of informed decision making similar to a pre-test genetic counseling session through a randomized clinical trial that will measure several parameters including change in knowledge, shared decision making, and decisional conflict.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients use an electronic decision aid in conjunction with an oncology provider visit for genetic testing decision-making on study.
ARM B: Patients undergo a pre-testing counseling session with a genetic counselor for genetic testing decision-making on study.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationDana-Farber Harvard Cancer Center
