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PEGI to Improve Shared Decision-Making for Breast Reconstruction (PEGI)

2018年9月25日 更新者:University Health Network, Toronto

Pre-consultation Educational Group Intervention to Improve Shared Decision-Making for Postmastectomy Breast Reconstruction

The purpose of this study is to determine the effectiveness of a pre-consultation decision support workshop for breast reconstruction after breast cancer, in facilitating the decision-making process, compared to routine pre-surgical education.

研究概览

详细说明

Postmastectomy breast reconstruction is becoming increasingly utilized in breast cancer patients to provide surgical restoration of the breast mounds. The breast reconstruction discussions can be highly complex, as there are many different techniques, timing, and complications that are unique to each procedure. However ¼ of women report being dissatisfied with some component of their cancer or reconstructive care. Failure of the physician to provide adequate information about treatment options is the most frequent source of cancer patient dissatisfaction and breast reconstruction patients have expressed a need for further information regarding the complex decision to pursue breast reconstruction. In such scenarios of complex medical decision-making, decision support techniques may be an effective solution to information provision and shared decision-making. As a result, the investigators developed a pre-consultation educational group intervention delivered in a group setting for women considering breast reconstruction, with the aims to fill an existing information-gap, promote high-quality decision-making and enhance decision self-efficacy and other decision measures. This study will evaluate the educational group intervention.

研究类型

介入性

注册 (实际的)

156

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • Toronto、Ontario、加拿大、M5G 2C4
        • Toronto General Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  1. Patients > 18 years of age.
  2. Seeking consultation for delayed Post Mastectomy Breast Reconstruction, or prophylactic mastectomy and immediate Post Mastectomy Breast Reconstruction for breast cancer prevention.

Exclusion Criteria:

  1. Chest wall or atypical breast malignancy that require chest wall reconstruction.
  2. Active invasive or in situ breast cancer.
  3. Consultation for breast revision or nipple reconstruction only.
  4. Patient cannot read or write in English.
  5. Cognitive impairment or uncontrolled psychiatric diagnosis.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:Standard Care
Routine pre-consultation education
实验性的:Educational group intervention
The pre-consultation educational group intervention will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.

Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.

  • Surgeon (40 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
  • Registered nurse (20 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
  • Social worker (30 mins): values clarification exercise
  • Breast reconstruction patient volunteers (30 mins) questions and answers about their personal experience

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Decisional Conflict Scale
大体时间:Change from baseline decision conflict at 1 week after surgical consultation
Decision conflict scale measures personal perceptions of uncertainty in choosing options and has been demonstrated to be valid and responsive to change. The decisional conflict scale is a 16-item 5-response instrument that reports a score from 0 - 100 with higher scores indicating more conflict (items are summed, divided by 16 and multiplied by 25).
Change from baseline decision conflict at 1 week after surgical consultation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Toni Zhong, MD, MHS、University Health Network, Toronto

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年2月15日

初级完成 (实际的)

2018年6月15日

研究完成 (实际的)

2018年9月15日

研究注册日期

首次提交

2016年4月6日

首先提交符合 QC 标准的

2016年4月6日

首次发布 (估计)

2016年4月12日

研究记录更新

最后更新发布 (实际的)

2018年9月26日

上次提交的符合 QC 标准的更新

2018年9月25日

最后验证

2018年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 13-7227-CE

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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