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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-07731 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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This clinical trial evaluates the impact of enhanced risk assessments on knowledge, perceptions, and decisional conflict about cancer prevention in women with a BRCA1 or BRCA2 mutation. BRCA1/2 mutation carriers have a much higher risk of developing breast and ovarian cancer. Due to the high risk of cancer, mutation carriers are provided guidelines on more intensive screening and preventative surgeries such as bilateral mastectomy and bilateral salpingo-oophorectomy. Doctors want to learn if a more personalized risk assessment impacts the patients' risk perceptions and comfort with decision-making around cancer prevention behaviors.
PRIMARY OBJECTIVES:
I. To deploy tools for delivering enhanced genetic risk predictions based on BRCA1/2 genetic risk modifiers in a clinical setting and assess the impact of risk stratification on genetic knowledge, risk perceptions and decisional conflict regarding cancer prevention decision-making.
II. To perform long-term follow-up of individuals in the randomized controlled trial (RCT) to determine if there are differences in satisfaction, decision-making and outcomes in individuals who received standard versus enhanced genetic risk predictions over time.
OUTLINE: Patients undergo collection of blood or mouthwash samples. Patients are then randomized to 1 of 2 arms.
ARM I: Patients undergo genotyping with enhanced risk assessment on study. 4 to 8 weeks later, patients receive a follow-up phone call for return of enhanced risk assessment results and tailored counseling.
ARM II: 4-8 weeks later, patients receive a standard follow-up phone call.
After completion of study intervention, patients are followed up for 2 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (enhanced risk assessment) | Experimental | Patients undergo collection of blood or mouthwash samples. Patients undergo genotyping with enhanced risk assessment on study. 4 to 8 weeks later, patients receive a follow-up phone call for return of enhanced risk assessment results and tailored counseling. |
|
| Arm II (standard) | Active Comparator | Patients undergo collection of blood or mouthwash samples. 4-8 weeks later, patients receive a standard follow-up phone call. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive standard care |
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| Measure | Description | Time Frame |
|---|---|---|
| Decisional conflict Regarding Cancer Risk Management | Decisional conflict regarding cancer risk management will be measured via a questionnaire. Comparison of this measure between the enhanced and standard arms adjusting for stratified randomization will be made using linear regression. The alpha level for the outcome will be 0.05. | Up to 3 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amanda E Toland | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States | ||
| Huntsman Cancer Institute/University of Utah |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| Biospecimen Collection | Procedure | Undergo collection of blood or mouthwash sample |
|
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| Counseling | Other | Receive tailored counseling |
|
|
| Discussion | Procedure | Participate in phone discussion |
|
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| Genotyping | Procedure | Undergo genotyping |
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| Molecular Risk Assessment | Procedure | Undergo enhanced risk assessment |
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| Questionnaire Administration | Other | Ancillary studies |
|
| Salt Lake City |
| Utah |
| 84112 |
| United States |
| ID | Term |
|---|---|
| D061325 | Hereditary Breast and Ovarian Cancer Syndrome |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| 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 |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D013048 | Specimen Handling |
| D003376 | Counseling |
| D005838 | Genotype |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D055614 | Genetic Phenomena |
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