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2020-12-01
2023-12-31
2023-12-31
269
NCT04330716
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
INTERVENTIONAL
Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers
This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2020-03-17 | N/A | 2024-01-18 |
2020-03-30 | N/A | 2024-01-19 |
2020-04-01 | N/A | 2024-01 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Health Services Research
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Group A: Standard genetic counseling Will receive standard genetic counseling prior to genetic testing. | BEHAVIORAL: Standard Genetic Counseling
|
| 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
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
1
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
