GeneBOPP: Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers
Study Details
Study Description
Brief Summary
This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
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The research study procedures include screening for eligibility, randomization and a series of questionnaires.
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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:
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video education
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in-person counseling
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Genetic testing will be performed by blood draw.
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It is expected that 500 people will participate in this study
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Participants will be in the research study for up to 5 yrs after enrollment
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Group A: Standard genetic counseling Will receive standard genetic counseling prior to genetic testing. |
Behavioral: Standard Genetic Counseling
Standard of care genetic counseling
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| Experimental: Group B: Educational video 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
Video tutorial about genetic testing
|
Outcome Measures
Primary Outcome Measures
- Rate of patients who have germline genetic tests [Up to 3 years]
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
Secondary Outcome Measures
- Patient Satisfaction Survey following intervention [Immediately 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.
- Result Disclosure Preference following intervention [Immediately following intervention]
Measurement and comparison by randomized arm and communication of results of patient disclosure preferences using survey instruments. Administered immediately following the intervention.
- Patient Satisfaction 2 months following intervention [after results have been received, two months post-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.
- Psychological distress following intervention [after results have been received, two months post-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.
- Knowledge about genetics testing [Immediately following intervention]
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.
- Decisional Regret [after results have been received, two months post-intervention]
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.
- Family communication of genetic test results [after results have been received, two months post-intervention]
Measurement of family communication. Family communication survey is administered two months following the intervention.
- Positive Results impact [after results have been received, four months post-intervention]
Measurement of impact of positive results for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention.
- Cascade testing in positives [after results have been received, four months post-intervention]
Measurement of cascade testing for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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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
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Age ≥ 18 years
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Breast, ovarian, pancreatic, or metastatic prostate cancer
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No prior cancer genetic testing
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Ability to understand and the willingness to sign an informed consent document
Exclusion Criteria:
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Pregnant
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Prisoners
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Inability to understand English as a spoken language in a healthcare context
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Known hematologic malignancy (e.g. CLL)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dana-Farber Cancer Institute | Boston | Massachusetts | United States | 02215 |
| 2 | Dana-Farber Cancer Institute at St. Elizabeth's Medical Center | Brighton | Massachusetts | United States | 02135 |
| 3 | Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center | Milford | Massachusetts | United States | 01757 |
| 4 | Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital | Weymouth | Massachusetts | United States | 02190 |
| 5 | Dana-Farber/New Hampshire Oncology-Hematology | Londonderry | New Hampshire | United States | 03053 |
| 6 | Lifespan Cancer Institute at Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
Sponsors and Collaborators
- Dana-Farber Cancer Institute
- Ambry Genetics
Investigators
- Principal Investigator: Huma Rana, MD, Dana-Farber Cancer Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19-652