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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA082346 | U.S. NIH Grant/Contract | View source | |
| R01CA108933 | U.S. NIH Grant/Contract | View source | |
| P30CA051008 | U.S. NIH Grant/Contract | View source | |
| GUMC-2004-133 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Genetic counseling may work as well over the telephone as it does in-person. It is not yet known whether genetic counseling by telephone is more effective than standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
PURPOSE: This randomized phase III trial is studying telephone-based genetic counseling to see how well it works compared to standard (in-person) genetic counseling in women at risk of carrying the BRCA1 or BRCA2 mutation.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Participants are stratified according to participating site. Participants are randomized to 1 of 2 groups.
After completion of genetic counseling, all participants are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 600 participants will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telephone Genetic Counseling | Experimental | Participants randomized to this arm will receive all genetic counseling via telephone. |
|
| Usual Care | Active Comparator | Participants randomized to usual care will receive standard in-person genetic counseling. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telephone Genetic Counseling | Behavioral | Participants will receive all genetic counseling via telephone |
|
| Measure | Description | Time Frame |
|---|---|---|
| Uptake of BRCA1/BRCA2 mutation testing as measured by genetic test results at 3 and 6 months | 6 months | |
| Knowledge assessed by genetic testing knowledge measure at post-counseling and 3 months | 3 months | |
| Decision making as assessed by Decisional Conflict Satisfaction at post-counseling and 3 months | 3 months | |
| Quality of life as assessed by SF-12 health survey at 3 and 6 months | 6 months | |
| Distress as assessed by Impact of Events Scale Brief Symptom Inventory MICRA at 3 and 6 months | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Costs by cost measurement post-counseling | 6 months | |
| Management behaviors as assessed by utilization of management options (e.g., mammography, surgery, and chemoprevention) at 6 and 12 months | 12 months |
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DISEASE CHARACTERISTICS:
Must have at least 10% chance of carrying the BRCA1/BRCA2 gene, as defined by ≥ 1 of the following:
Must live within 100 miles of the Lombardi Comprehensive Cancer Center
No more than 4 weeks since breast or ovarian cancer diagnosis
No metastatic or inflammatory breast cancer or ovarian cancer
No stage III breast or ovarian cancer while undergoing concurrent chemotherapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Schwartz, PhD | Lombardi Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lombardi Comprehensive Cancer Center at Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26455498 | Derived | Peshkin BN, Kelly S, Nusbaum RH, Similuk M, DeMarco TA, Hooker GW, Valdimarsdottir HB, Forman AD, Joines JR, Davis C, McCormick SR, McKinnon W, Graves KD, Isaacs C, Garber J, Wood M, Jandorf L, Schwartz MD. Patient Perceptions of Telephone vs. In-Person BRCA1/BRCA2 Genetic Counseling. J Genet Couns. 2016 Jun;25(3):472-82. doi: 10.1007/s10897-015-9897-6. Epub 2015 Oct 12. | |
| 24449235 | Derived | Schwartz MD, Valdimarsdottir HB, Peshkin BN, Mandelblatt J, Nusbaum R, Huang AT, Chang Y, Graves K, Isaacs C, Wood M, McKinnon W, Garber J, McCormick S, Kinney AY, Luta G, Kelleher S, Leventhal KG, Vegella P, Tong A, King L. Randomized noninferiority trial of telephone versus in-person genetic counseling for hereditary breast and ovarian cancer. J Clin Oncol. 2014 Mar 1;32(7):618-26. doi: 10.1200/JCO.2013.51.3226. Epub 2014 Jan 21. |
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| Usual Care | Behavioral | subjects will receive standard in-person genetic counseling |
|
| Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute | Boston | Massachusetts | 02115-6084 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Vermont Cancer Center at University of Vermont | Burlington | Vermont | 05405-0110 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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