Genetic Testing Decision Aid

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Randomized, Controlled Trial of an Electronic Decision Aid for Genetic Testing in Inherited Cancer Syndromes

Conditions
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Epithelial Ovarian Carcinoma, Pancreas Adenocarcinoma

Intervention / Treatment
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* Behavioral: Electronic Decision Aid
* Behavioral: Pre-Test Genetic Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic decision aid arm<br>Receive decision aid followed by an appointment with their oncologist. | Behavioral: Electronic Decision Aid<br>* Decision aid followed by an appointment with an oncologist. Will complete surveys/questionnaires<br>|
| Active Comparator: Genetic counselor Arm<br>Receive pretest counseling with a genetic counselor. | Behavioral: Pre-Test Genetic Counseling<br>* Receive pretest counseling with a genetic counselor. Will complete surveys/questionnaires<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 1 week after genetics session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | At the conclusion of genetics session (day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pancreas adenocarcinoma., epithelial ovarian carcinoma, decision aid, inherited cancer syndrome, genetic testing