Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Prognostic Stage IA Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Prognostic Stage I Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Invasive Breast CarcinomaPrognostic Stage II Breast Cancer AJCC v8
- Interventions
- Other: Decision AidOther: Questionnaire Administration
- Registration Number
- NCT02918474
- Lead Sponsor
- M.D. Anderson Cancer Center
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 15
- Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadic unilateral invasive breast cancer
- Able to speak read or write English
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Supportive care (decision making tool) Decision Aid Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation. Supportive care (decision making tool) Questionnaire Administration Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation.
- Primary Outcome Measures
Name Time Method Acceptability of the decision support tool Up to 2 years 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.
Changes in patient's knowledge of contralateral prophylactic mastectomy (CPM) Baseline up to 2 years 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.
Reductions in decisional conflict about CPM Baseline up to 2 years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
M D Anderson Cancer Center
🇺🇸Houston, Texas, United States