Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers

Study Overview
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Brief Summary
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This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.

Detailed Description
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This prospective, randomized controlled trial will evaluate the effect of two pre-test education methods on the level of participation in genetic testing for hereditary cancer risk. A prospective study examines outcomes before the development of a disease. The research study procedures include screening for eligibility, randomization and a series of questionnaires. Participants will be randomized, or assigned by chance, to one of two methods of pre-genetic test education and after completing either pre-test education participants will be offered the opportunity to have genetic testing performed Two methods of pre-genetic test education: video education in-person counseling Genetic testing will be performed by blood draw. It is expected that 500 people will participate in this study Participants will be in the research study for up to 5 yrs after enrollment

Official Title
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Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers - GeneBOPP

Conditions
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Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Metastatic Prostate Cancer

Intervention / Treatment
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* Behavioral: Standard Genetic Counseling
* Behavioral: Educational Video


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Potentially eligible participants will be identified via medical record screening and/or in accordance with their clinical visit. A HIPAA waiver of authorization will be obtained by the enrolling Institution as needed to have access to the subject's medical record information for screening of eligibility. A member of the study team will approach the potentially eligible participant in clinic and discuss the trial. Potentially eligible participants may choose to discuss participation further with their physician at their appointment Age ≥ 18 years Breast, ovarian, pancreatic, or metastatic prostate cancer No prior cancer genetic testing Ability to understand and the willingness to sign an informed consent document Exclusion Criteria: Pregnant Prisoners Inability to understand English as a spoken language in a healthcare context Known hematologic malignancy (e.g. CLL)

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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Accepts Healthy Volunteers

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 |
| --- | --- |
| Active Comparator: Group A: Standard genetic counseling<br>Will receive standard genetic counseling prior to genetic testing. | Behavioral: Standard Genetic Counseling<br>* Standard of care genetic counseling<br>|
| Experimental: Group B: Educational video<br>Will watch a brief educational video that is approximately 8 minutes in length about the genetic testing process and what to expect prior to genetic testing. | Behavioral: Educational Video<br>* Video tutorial about genetic testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients who have germline genetic tests | Measurement of genetic testing uptake in breast, ovarian, pancreatic, and prostate cancer patients randomized to pre-genetic test (pre-test) in-person counseling with a genetic counselor per standard of care or video education.This comparison will use a two-sided Fisher exact test | Up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Survey following intervention | Measurement and comparison by randomized arm and communication of results of patient satisfaction using survey instruments. Administered immediately following the intervention. The survey evaluates the subject's satisfaction with the genetic testing process for both arms. | Immediately following intervention | 
| Result Disclosure Preference following intervention | Measurement and comparison by randomized arm and communication of results of patient disclosure preferences using survey instruments. Administered immediately following the intervention. | Immediately following intervention | 
| Patient Satisfaction 2 months following intervention | Measurement and comparison by randomized arm and communication of results of patient satisfaction using survey instruments. Administered two months after the intervention. The survey evaluates the subject's satisfaction with the genetic testing process for both arms. | after results have been received, two months post-intervention | 
| Psychological distress following intervention | MICRA is a widely used validated 25-item measure that assesses psychosocial consequences associated with genetic testing for cancer. Section 1 contains 3 sub-scales: the Positive sub-scale (4 items), the Distress sub-scale (6 items), and the Uncertainty sub-scale (9 items) and two other items that do not fit into either sub-scale. Section 2 contains two items for participants who have children. Section 3 contains 2 items for participants who have/have had cancer. Responses are indicated on a 4 point scale for experiences in the past week. A higher score in the sub-scales or total scale indicated greater distress. The positive sub-scale is reverse scored to reflect this. | after results have been received, two months post-intervention | 
| Knowledge about genetics testing | Measurement and comparison by randomized arm and communication of results of Patient knowledge about genetics testing using survey instruments. Knowledge about genetic testing is evaluated through a Knowledge of Multigene Panel Testing survey immediately following the intervention. | Immediately following intervention | 
| Decisional Regret | Measurement and comparison by randomized arm and communication of results of Patient decisional regret to have genetic testing. Decisional regret is evaluated through a decisional regret survey that is administered two months after intervention. | after results have been received, two months post-intervention | 
| Family communication of genetic test results | Measurement of family communication. Family communication survey is administered two months following the intervention. | after results have been received, two months post-intervention | 
| Positive Results impact | Measurement of impact of positive results for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention. | after results have been received, four months post-intervention | 
| Cascade testing in positives | Measurement of cascade testing for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention. | after results have been received, four months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Metastatic Prostate Cancer, Genetic Counseling, Genetic Testing