Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA135179-01 | U.S. NIH Grant/Contract | View source | |
| R01HG005055 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Human Genome Research Institute (NHGRI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This non-therapeutic trial is for women who have received results of genetic testing for BRCA1/2 mutations. The trial compares decision support tools designed to facilitate informed decision making regarding risk management following testing to usual care. The researchers will test separate decision support tools for women who receive positive test results and women who receive negative/inconclusive test results. Among women who receive a positive test result, an interactive decision support intervention will be compared to a print intervention. Among women who receive an inconclusive result, an interactive intervention will be compared to usual care.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mutation Carrier: Enhanced Internet DA | Experimental | BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. |
|
| Mutation Carrier: Internet DA | Experimental | BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support intervention without a preference clarification tool. |
|
| Mutation Carrier: Enhanced Print DA | Active Comparator | BRCA1/2 carriers randomized to this arm will be sent a print-based decision aid with a print preference clarification tool. |
|
| Mutation Carrier: Print DA | Active Comparator | BRCA1/2 carriers randomized to this arm will receive a print decision aid without a preference clarification tool. |
|
| Inconclusive Results: DA | Experimental | Participants who receive inconclusive results who are randomized to this arm will have access to an Internet decision tool designed to facilitate management decision making |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Internet DA | Behavioral | BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options. |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge | Knowledge of risk management options. | 1-month post randomization |
| Decision Conflict | Decisional Conflict Scale | 1-month post-randomization |
| Decision Satisfaction | Satisfaction with Decision Scale | 12-months post-randomization |
| Psychological Distress | 1-month post randomization | |
| Health Related Quality of Life | SF-12 | 12-months post randomization |
| Utilization of breast and ovarian cancer risk management options | We will assess uptake of the following risk management strategies:
| 12-months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge | Knowledge of risk management options | 3-months post randomization |
| Psychological Distress | 3-months post-randomization | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc D Schwartz, PhD | Georgetown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center/Lombardi Comprehensive Cancer Center | Washington D.C. | District of Columbia | 20007 | United States |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| C562840 | Breast Cancer, Familial |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Inconclusive Results: Usual care | No Intervention | Participants who receive inconclusive/uninformative results who are randomized to this arm will receive usual care but no additional decision support intervention |
|
| Internet DA | Behavioral | BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support. This intervention is designed to provide education regarding the available risk management options. |
|
| Enhanced Print DA | Behavioral | BRCA1/2 carriers randomized to this arm will receive print-based decision support materials which include a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options. |
|
| Print DA | Behavioral | BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options. |
|
| Inconclusive Results DA | Behavioral | Women who receive uninformative BRCA1/2 results randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options. |
|
| Decisional Conflict |
Decisional Conflict Scale |
| 3-months post-randomization |
| 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 |