Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial
Official title:
Decision Making Tool for Contralateral Prophylactic Mastectomy
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.
| Status | Recruiting |
| Enrollment | 15 |
| Est. completion date | September 30, 2026 |
| Est. primary completion date | September 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadic unilateral invasive breast cancer - Able to speak read or write English Exclusion Criteria: - Patients with previous breast cancer - Prior history of bilateral prophylactic mastectomy - Known to have a germline mutation that predisposes them to an increased risk of breast cancer (e.g. BRCA1/2) and/or they are considered at high risk for contralateral breast cancer on the basis of a strong family history of cancer |
| Country | Name | City | State |
|---|---|---|---|
| United States | M D Anderson Cancer Center | Houston | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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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|---|---|---|---|
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