临床试验/NCT04242667

NCT04242667已完成不适用

A Randomized Protocol Evaluating Return of Actionable Genetic Research Results to Biobank Participants

Abramson Cancer Center at Penn Medicine2 个研究点分布在 1 个国家目标入组 260 人开始时间: 2020年3月1日最近更新: 2024年7月1日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Abramson Cancer Center at Penn Medicine
入组人数: 260
试验地点: 2
主要终点: Completion of surveys

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The overall goal of the proposed research is to assess the feasibility of a randomized study evaluating the non-inferiority of an electronic Health (e-Health) delivery alternative (e.g. private web portal) as compared to return of actionable genetic research results with a genetic counselor.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
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: 否

入选标准

•Consented participant in University of Pennsylvania Biobank who previously submitted a DNA sample for research testing
•English speaking
•Aged 18 years or older
•Agreed to be re-contacted in the future or did not indicate a preference on future contact regarding research results
•Have an actionable mutation or have been selected as a control participant
•Have not previously received actionable results of clinical genetic testing

排除标准

•Deceased assessed by electronic medical record, death index or identified after contact
•Evidence in the electronic medical record that the subject has already received the same actionable result through clinical genetic testing

结局指标

主要结局

Completion of surveys

时间窗: Baseline survey prior to disclosure of results, and then two post-disclosure surveys at 2-7 days and 6 months

Participant will self-complete surveys to collect psychological and knowledge outcomes

次要结局

未报告次要终点

研究者

发起方

Abramson Cancer Center at Penn Medicine

申办方类型

Other

责任方

Sponsor

研究点 (2)

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