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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA108933 | U.S. NIH Grant/Contract | View source | |
| R01CA074861 | U.S. NIH Grant/Contract | View source | |
| P30CA051008 | U.S. NIH Grant/Contract | View source | |
| GUMC-2004-212 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Genetics education and counseling may help patients make treatment decisions. It is not yet known how genetic counseling or usual care influence patient treatment decisions for breast cancer.
PURPOSE: This randomized clinical trial is studying how well genetic counseling works compared to usual care in helping patients with newly diagnosed ductal carcinoma in situ, stage I, stage II, or stage IIIA breast cancer make treatment decisions.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating site. Patients are randomized to 1 of 2 interventional arms.
In both arms, quality of life is assessed at baseline and at 1, 6, and 12 months.
After completion of the study, patients are followed periodically for 1 year.
PROJECTED ACCRUAL: A total of 360 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rapid genetic counseling | Experimental | Following randomization, participants will be informed about whether they are assigned to Usual Care (UC) or Rapid Genetic Counseling (RGC). Participants in the UC arm can schedule a genetic counseling appointment at any time during the study if they wish. Participants in the RGC agree to obtain genetic counseling as soon as possible, before they make a definitive surgery decision. RGC can be accomplished by telephone or in-person. The RGC intervention is delivered by highly experienced genetic counselors at each site. This counseling is identical to our standard genetic counseling procedure for newly diagnosed patients. Immediate DNA collection via blood or buccal cell collection is available following counseling. Phone counseling participants will be been mailed a kit for DNA collection or have the option of having the sample collected at at LCCC. |
|
| Usual Care | No Intervention | Usual Care (UC) for newly diagnosed breast cancer patients does not typically include a pre-surgical genetic referral. These patients may obtain genetic counseling at their own discretion. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| counseling intervention | Behavioral |
| ||
| educational intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Definitive surgery choice as measured by self-reported and medical record verification at 6 months after randomization | 1, 6, and 12 months | |
| Quality of life as measured by functional assessment of cancer therapy for breast cancer (FACT-B) at 1, 6, and 12 months after randomization | 1, 6, and 12 months | |
| Distress as measured by Impact of Events Scale Brief Symptom Inventory at 1, 6, and 12 months after randomization | 1, 6, and 12 months | |
| Knowledge as assessed by Genetic Testing Knowledge Measure at 1 month after randomization | 1 month | |
| Decision outcomes as assessed by Decisional Conflict Scale Satisfaction with Decision Scale at 1 and 6 months after randomization | 1 and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cost effectiveness as measured by quality adjusted life years saved at 12 months after randomization | 12 months |
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DISEASE CHARACTERISTICS:
Newly diagnosed breast cancer, meeting 1 of the following criteria:
Must meet 1 of the following criteria:
Diagnosis before 50 years of age
Diagnosis after 50 years of age AND has 1 of the following:
Must not have initiated definitive treatment for breast cancer
No bilateral, metastatic, or inflammatory breast cancer
No prior BRCA1/2 counseling or testing
No prior diagnosis of metastatic cancer of any type
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
PRIOR CONCURRENT THERAPY:
Surgery
Other
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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 |
|---|---|---|---|
| 29611029 | Derived | Schwartz MD, Peshkin BN, Isaacs C, Willey S, Valdimarsdottir HB, Nusbaum R, Hooker G, O'Neill S, Jandorf L, Kelly SP, Heinzmann J, Zidell A, Khoury K. Randomized trial of proactive rapid genetic counseling versus usual care for newly diagnosed breast cancer patients. Breast Cancer Res Treat. 2018 Aug;170(3):517-524. doi: 10.1007/s10549-018-4773-3. Epub 2018 Apr 2. |
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| Other |
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| psychosocial assessment and care | Procedure |
|
| Chevy Chase | Maryland | 20815 | United States |
| Hackensack University Medical Center Cancer Center | Hackensack | New Jersey | 07601 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D018479 | Early Intervention, Educational |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D002662 | Child Health Services |
| D011314 | Preventive Health Services |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |
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