Breast Reconstruction Decision Aid (RECONJOINT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 131
- 试验地点
- 9
- 主要终点
- Feasibility determined by participant accrual
研究概览
简要总结
The purpose of this study is to find out whether it is practical (feasible) to do a larger study looking at the effectiveness of the Breast Reconstruction Decision Aid Tool (RECONJOINT) for breast reconstruction surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant Inclusion Criteria
- •Focus Group Participants
- •A diagnosed genetic predisposition to breast cancer or a diagnosis of ductal carcinoma in situ or any invasive cancer confirmed through review of the medical record
- •≥18 years old
- •Considering post-mastectomy breast reconstruction
- •RCT Participants (Patients)
- •A diagnosed genetic predisposition to breast cancer or a diagnosis of ductal carcinoma in situ or any invasive cancer confirmed through review of the medical record
- •≥18 years old
- •Considering post-mastectomy breast reconstruction
- •Have an appointment scheduled for consultation with a plastic surgery provider
- •RCT Participants (Physicians)
- •Provides breast reconstruction care ≥ 50% of the time. This is defined as over half of the surgeon's cases in the preceding calendar year being related to breast reconstruction surgery.
- •Participant
排除标准
- •Focus Group Participants
- •Not considering post-mastectomy breast reconstruction
- •Non-English proficiency
- •RCT Participants (Patients)
- •Not considering postmastectomy breast reconstruction
- •Recurrent or metastatic breast cancer
- •Non-English proficiency
- •RCT Participants (Physicians)
- •Does not provide breast reconstruction care at least 50% of the time
- •Non-English proficiency
研究组 & 干预措施
Focus Group Participants
Participants will receive usual care
RECONJOINT/RCT Participants (Patients)
Participants in the RECONJOINT intervention arm will receive the decision aid in addition to enhanced usual care
干预措施: RECONJOINT (Other)
RCT Participants (Physicians)
Participating surgeons will be randomized to Enhanced Usual Care or Intervention with a 1:1 ratio
干预措施: RECONJOINT (Other)
结局指标
主要结局
Feasibility determined by participant accrual
时间窗: <60 days after initial reconstructive surgery consult and before pt's breast reconstruction surgery
Determine the feasibility of a hybrid effectiveness-implementation study that investigates the effectiveness and implementation potential of a decision aid to improve shared decision-making in breast reconstruction.
次要结局
未报告次要终点