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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02660 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PA16-0469 | Other Identifier | M D Anderson Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial studies the acceptability and how well decision making tool works in supporting decision making in contralateral prophylactic mastectomy in patients with newly diagnosed breast cancer. Decision making tool may help patients with early stage breast cancer make decisions regarding their surgical options.
PRIMARY OBJECTIVES:
I. An online decision support tool will be field tested that provides patients facing a decision about contralateral prophylactic breast cancer (CPM) with evidence-based information about the expected incidence of contralateral breast cancer and the life expectancy benefit of CPM. The tool will be designed for use in clinical settings and viewed jointly by the patient and physician as part of a shared decision making process around CPM.
OUTLINE:
Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (decision making tool) | Experimental | Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision Aid | Other | Use decision making tool |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptability of the decision support tool | Patients' rating of the acceptability of the decision support tool will be assessed using questions from the Ottawa Acceptability Measures, including the clarity, amount, and balance of the information provided by the tool. Acceptability data from patients enrolled in the field test will be reported descriptively. | Up to 2 years |
| Changes in patient's knowledge of contralateral prophylactic mastectomy (CPM) | Will test for change in knowledge from before to after administration of the decision support tool with a breast cancer surgeon using paired samples t-tests. | Baseline up to 2 years |
| Reductions in decisional conflict about CPM | Will be assessed using the Decisional Conflict Scale. Will test for reduction in decisional conflict from before to after administration of the decision support tool with a breast cancer surgeon using paired samples t-tests. | Baseline up to 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abenaa M Brewster | Contact | 713-745-4949 | abrewster@mdanderson.org |
| Name | Affiliation | Role |
|---|---|---|
| Abenaa M Brewster | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Questionnaire Administration |
| Other |
Ancillary studies |
|
| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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