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临床试验/NCT04168736
NCT04168736已完成不适用

Family Disclosure in Cascade Testing

University of Virginia1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
percentage of family members told in comparison to number of family members

研究概览

简要总结

Prospective cohort study to evaluate the feasibility and acceptability of using standardized educational and communication tools to assist in communication of genetic test results to family members. A pre and post test will be administered to consented patients before and after genetic counseling .

详细描述

This will be a prospective cohort study to evaluate 1) the feasibility and acceptability of using standardized educational and communication tools to assist in communication of genetic test results to family members, 2) utility of the communication tool, and 3) the impact of a patient focused information sheet on the knowledge of genetic testing in women who attend the women's oncology clinic. Genetic counseling is recommended for all women with a diagnosis of ovarian cancer, most patients with pre-menopausal diagnosis of breast cancer, and in younger women with uterine or other gynecologic malignancies. Women with a diagnosis of breast or gynecologic cancer who elect to undergo genetic testing will be approached to participate in this study. If they consent, they will be provided with two information handouts (FORCE sharing worksheets) and family letter template. Participants will complete a baseline knowledge survey prior to receipt of these materials. At a second visit, they will complete the knowledge survey again. Knowledge surveys will be scored and pre and post test scores will be compared with a paired t-test. Feasibility will be assessed by tracking the number of patients approached to participate, the number who sign consents, and the number who complete the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
接受健康志愿者

入选标准

  • Diagnosis of breast or gynecologic cancer
  • Undergoing any genetic testing at UVA for standard clinical purposes in the Women's Oncology Clinic

排除标准

  • Not receiving treatment at UVA
  • Not English literate
  • Unable to provide consent
  • Known pregnancy (self-reported)

结局指标

主要结局

percentage of family members told in comparison to number of family members

时间窗: 1 year

Evaluate the feasibility and acceptability of using standardized educational and communication tools to assist in communication of genetic test results to family members

次要结局

  • percentage of participants that report using the intervention(1 year)
  • To compare pre- and post test scores to accesses the gaps in traditional genetic counseling education sessions(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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