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| Name | Class |
|---|---|
| Ambry Genetics | INDUSTRY |
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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.
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.
Two methods of pre-genetic test education:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Standard genetic counseling | Active Comparator | Will receive standard genetic counseling prior to genetic testing. |
|
| Group B: Educational video | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Genetic Counseling | Behavioral | Standard of care genetic counseling |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Huma Rana, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Dana-Farber Cancer Institute at St. Elizabeth's Medical Center |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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| Educational Video | Behavioral | Video tutorial about genetic testing |
|
| 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 |
| Brighton |
| Massachusetts |
| 02135 |
| United States |
| Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center | Milford | Massachusetts | 01757 | United States |
| Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital | Weymouth | Massachusetts | 02190 | United States |
| Dana-Farber/New Hampshire Oncology-Hematology | Londonderry | New Hampshire | 03053 | United States |
| Lifespan Cancer Institute at Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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