跳至主要内容
临床试验/NCT02406235
NCT02406235已完成不适用

Evaluating a Novel Onco-genetic BRCA Testing Counselling Model Among Patients With Ovarian Cancer - ENGAGE Study

AstraZeneca1 个研究点 分布在 1 个国家目标入组 710 人开始时间: 2015年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
710
试验地点
1
主要终点
Assessing turnaround time with the new BRCA-testing pathway

研究概览

简要总结

The overall objective of this study is to assess turnaround time, pre-BRCA test onco-genetic counselling quality and satisfaction with a new onco-genetic BRCA testing model.

详细描述

This will be a prospective observational study of patients diagnosed with epithelial ovarian/fallopian tube/primary peritoneal cancer prior to, or at enrolment in this study. The study is descriptive in nature and does not attempt to test any specific a priori hypotheses.

Clinical teams (physicians and nurses) will be trained to discuss BRCA testing with ovarian cancer patients who meet study criteria and consent to participate in the study. Patients will be recruited from participating sites in North America and Europe. Patients selected per the study inclusion and exclusion criteria will be consented for participation in the study. Patients will be recruited during an estimated 12 month period and participating patients will be followed from enrollment in the study until provision of BRCA test results, final genetics counselling, and completion of satisfaction survey or death. A case report form will be developed to collect information on the primary variable of interest (i.e., turnaround time), patient and disease characteristics, medical history, treatment patterns and outcome of the BRCA test. In addition, a survey will be developed to evaluate patient's assessment of pre- BRCA onco-genetic counseling quality and satisfaction with onco-genetic testing process.

Finally, surveys will be developed to evaluate oncologist (or oncology nurse) and genetic counselor's assessment of the processes associated with the onco-genetic testing pathway.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with epithelial ovarian/fallopian tube/primary peritoneal cancer
  • Patients aged 18 years or older at ovarian cancer diagnosis
  • Provision of written informed consent
  • Patient is able to read, write, and understand the material presented to them as part of this study, per the discretion of the physician

排除标准

  • Patients with low grade epithelial ovarian cancer or non-epithelial ovarian cancer
  • Patients enrolled in an interventional clinical trial for ovarian cancer or other malignancy at the time of conduct of this study
  • Patients with BRCA testing any time prior to the study enrollment

结局指标

主要结局

Assessing turnaround time with the new BRCA-testing pathway

时间窗: participating patients will be followed from enrollment in the study until provision of BRCA test results, final genetics counselling and completion of satisfaction survey or death, an expected average of 2 months

The primary objectives include a) assessing turnaround time with the new BRCA (Breast Cancer)-testing pathway; b) patient's assessment of pre-BRCA test onco-genetic counselling quality and satisfaction with the onco-genetic BRCA testing pathway; c) oncologists, and genetic counsellor's assessment of onco-genetic BRCA testing process. The study will be limited to patients with a diagnosis of ovarian cancer.

次要结局

未报告次要终点

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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