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临床试验/NCT05140252
NCT05140252已完成不适用

Avoiding Low-value Treatments in Older Women With Early-stage Breast Cancer: Piloting a Patient Decision Aid

University of Michigan Rogel Cancer Center1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年5月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Engagement with the patient decision aid

研究概览

简要总结

The aim of this study is to learn whether participants find a patient guide to breast cancer treatment decisions acceptable and appropriate for use.

详细描述

This study seeks to adapt and pilot test de-implementation strategies targeting low-value breast cancer treatments which have persisted despite national recommendations. Breast cancer is an ideal setting in which to study de-implementation given it is common, well-studied, typically presents at an early-stage, and care is provided primarily in a community setting.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Early stage breast cancer that is hormone receptor positive (HR+) and human epidermal growth factor negative (HER2-)
  • •Meet criteria for omission of sentinel lymph node biopsy (SLNB)
  • •Receiving care at Michigan Medicine

排除标准

  • •Non-English speaking
  • •Male patients (current data does not support omission of SLNB in men)

研究组 & 干预措施

Breast cancer decision aid

Experimental

Participants receive a breast cancer decision aid.

干预措施: Breast cancer decision aid (Behavioral)

结局指标

主要结局

Engagement with the patient decision aid

时间窗: 1 week after receiving decision aid

To determine feasibility, participants will be asked whether they engaged with the patient decision aid (1=thoroughly, 2=somewhat or 3=not at all), scored as a mean. The median score across all participants will be reported.

Acceptability of Intervention (AIM) Survey

时间窗: 1 week after receiving decision aid

AIM is a validated, 4-item survey with all items measured on a 5-point Likert scale (Completely Disagree \[1\] - Completely Agree \[5\]), scored as a mean. The median score across all participants will be reported.

Intervention Appropriateness Measure (IAM)

时间窗: 1 week after receiving decision aid

IAM is a validated, 4-item survey with all items measured on a 5-point Likert scale (Completely Disagree \[1\] - Completely Agree \[5\]), scored as a mean. The median score across all participants will be reported.

次要结局

  • Satisfaction with decision (SWD)(up to 120-days following surgery)
  • Treatment choice(90 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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