Genetic Testing Decision Aid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Electronic Decision Aid
BehavioralDecision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires
Pre-Test Genetic Counseling
BehavioralReceive pretest counseling with a genetic counselor. Will complete surveys/questionnaires
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Electronic decision aid armExperimental treatment 1 intervention
Group B: Genetic counselor ArmActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average change in knowledge survey score
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.
Time frame
baseline (prior to participant completing either genetics sessions) to 1-week following session, approximately 2 weeks2
Decisional Conflict Scores
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.
Time frame
1 week after genetics session3
Shared Decision Making Process Scores
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.
Time frame
1 week after genetics sessionSecondary outcomes
1
Average time between genetic testing recommendation and sample collection
Difference between the two study arms in the time it takes between participants being recommended for genetic testing and a sample being collected.
Time frame
Initial recorded recommendation/referral for genetic testing until the date of sample collection, assessed up to 6 months2
Average Duration of Decision Making Process
Amount of time patients spend learning and making a decision about genetic testing in both arms of the study.
Time frame
Approximately 30 minutes - 1 hour3
Ratio of the number of participants who chose each of the three panels offered
Ratios of participants who choose the small, intermediate, and broad testing panel in both arms of the study.
Time frame
At the conclusion of genetics session (day 1)4
Percentage of participants choosing genetic testing
Percentage of participants in each arm of the study who choose to get genetic testing after the educational intervention
Time frame
At the conclusion of genetics session (day 1)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov