Breast Cancer, Ovarian Cancer
Conditions
Keywords
Genetic counseling, genetic testing, BRCA1, BRCA2, Hereditary breast cancer, Hereditary ovarian cancer
Brief summary
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.
Interventions
BEHAVIORALEnhanced Internet DA
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.
BEHAVIORALInternet DA
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.
BEHAVIORALEnhanced Print DA
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.
BEHAVIORALPrint DA
BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.
BEHAVIORALInconclusive Results DA
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.
Sponsors
National Cancer Institute (NCI)
National Human Genome Research Institute (NHGRI)
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Undergo BRCA1/2 genetic counseling and testing at one of four study sites * Receive positive or uninformative test results * English speaking
Exclusion criteria
* Newly diagnosed breast cancer patients who have not yet initiated definitive breast cancer treatment * Previous bilateral mastectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Utilization of breast and ovarian cancer risk management options | 12-months post-randomization | We will assess uptake of the following risk management strategies: 1. Risk reducing surgery (mastectomy and oophorectomy) 2. Chemoprevention 3. Breast and ovarian cancer screening |
| Decision Satisfaction | 12-months post-randomization | Satisfaction with Decision Scale |
| Psychological Distress | 1-month post randomization | — |
| Health Related Quality of Life | 12-months post randomization | SF-12 |
| Knowledge | 1-month post randomization | Knowledge of risk management options. |
| Decision Conflict | 1-month post-randomization | Decisional Conflict Scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Distress | 3-months post-randomization | — |
| Decisional Conflict | 3-months post-randomization | Decisional Conflict Scale |
| Knowledge | 3-months post randomization | Knowledge of risk management options |
Countries
United States
Outcome results
None listed