Decision Making Tool for Contralateral Prophylactic Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Acceptability of the decision support tool
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed ductal breast carcinoma in situ (DCIS) or stage I-III sporadic unilateral invasive breast cancer
- •Able to speak read or write English
排除标准
- •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
研究组 & 干预措施
Supportive care (decision making tool)
Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation.
干预措施: Decision Aid (Other)
Supportive care (decision making tool)
Patients use decision making tool during consultation with breast cancer surgeon and complete questionnaires before and after consultation.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Acceptability of the decision support tool
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点