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临床试验/NCT03983577
NCT03983577招募中不适用

Efficacy of Point Of Service Testing in Metastatic Breast Cancer

University of Kansas Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年6月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention.

研究概览

简要总结

This study will assess the efficacy of an innovative point of service cancer genetics counseling delivery model for metastatic breast cancer (MBC) patients whom have received a referral for hereditary cancer genetic counseling and testing.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent.
  • Able to speak and read in the English language.
  • Have a diagnosis of human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer.
  • Participants must be enrolled in the parent registry study.

排除标准

  • Genetic testing for a breast cancer gene (BRCA) BRCA1 and BRCA2 mutation completed after 2013 or any BRCA 1 and BRCA2 testing with large rearrangement testing. Prior genetic counseling is allowed.
  • Psychiatric illness/social situations that would limit compliance with study requirements.

结局指标

主要结局

Proportion of patients/participants that undergo hereditary cancer genetic testing after the telehealth intervention.

时间窗: 24 months

Defined as the number of participants who opt to undergo hereditary cancer genetic testing as a percentage of the total number of participants enrolled.

次要结局

  • Clinical decisional conflict score(24 months)
  • Overall participant satisfaction(24 months)
  • Overall participant anxiety(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Efficacy of Point Of Service Testing in MBC | 临床试验