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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
350
Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires
Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGMass General at North Shore Cancer Center
Danvers, Massachusetts, United States
RECRUITINGAverage 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 weeks
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 session
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 session
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 months
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.
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Time frame: Approximately 30 minutes - 1 hour
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)
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)