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临床试验/NCT06671704
NCT06671704招募中不适用

GC-PRO Intervention

University of Minnesota1 个研究点 分布在 1 个国家目标入组 994 人开始时间: 2025年1月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
994
试验地点
1
主要终点
effectiveness of a genetic counseling skills training intervention

研究概览

简要总结

The goal of the GC-PRO study is to try to make genetic counseling better for people of all backgrounds. We are asking participants to complete two surveys and to allow audio recording of their genetic counseling visit. The purpose of the study is to understand whether trying different ways of doing genetic counseling will lead to better experiences for patients. The research team is also working with partners from the Somali, Latino/Hispanic, Black/African American, and Hmong communities to make sure the research is being done in a way that will benefit underserved communities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
Single (Participant)

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

  • Aged 18 years or older
  • individual OR their child has been referred to genetic counseling for family and/or personal history of hereditary cancer, cardiology condition, general genetics indication, or reproductive/prenatal indication at a participating study site
  • understand and be able to provide information for study forms and surveys in English.

排除标准

  • Unable to provide informed consent
  • For pediatric genetic counseling referrals, individuals who are not the parent or legal guardian of the child will be excluded from participating.

研究组 & 干预措施

Cluster 1

Experimental

Patients recruited and randomized to transfer from standard of care to genetic counselling in months 4-15

干预措施: Genetic counseling months 4-15 (Other)

Cluster 2

Experimental

Patients recruited and randomized to transfer from standard of care to genetic counselling in months 6-15

干预措施: Genetic counseling months 6-15 (Other)

Cluster 3

Experimental

Patients recruited and randomized to transfer from standard of care to genetic counselling in months 8-15

干预措施: Genetic counseling months 8-15 (Other)

Cluster 4

Experimental

Patients recruited and randomized to transfer from standard of care to genetic counselling in months 10-15

干预措施: Genetic counseling at months 10-15 (Other)

Cluster 5

Experimental

Patients recruited and randomized to transfer from standard of care to genetic counselling in months 12-15

干预措施: Genetic counseling at months 12-15 (Other)

Cluster 6

Experimental

Patients recruited and randomized to transfer from standard of care to genetic counselling in months 14-15

干预措施: Genetic counseling at months 14-15 (Other)

结局指标

主要结局

effectiveness of a genetic counseling skills training intervention

时间窗: 1 month

The exact measure of effectiveness has been omitted to ensure no bias is created and that research integrity is preserved

次要结局

  • patient perception of overall GC quality(1 month)
  • patient-centered communication(1 month)
  • patient empowerment(1 month)
  • patient activation(1 month)
  • patient information needs met / information overload(1 month)
  • patients' perceived trust in GC(1 month)
  • working alliance(1 month)
  • GC verbal dominance(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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