Prospective, Randomized Non-inferiority Trial of Streamlined Genetic Education and Testing for High-grade Epithelial Ovarian, Fallopian and Peritoneal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Numeracy assessment
研究概览
简要总结
Current guidelines recommend universal genetic testing for all patients with ovarian, fallopian and peritoneal cancer. The purpose of this trial is to investigate the non-inferiority of streamlined genetics education and testing for this patient population when compared to the traditional model of referral to genetic counseling. Patients will be randomized to either the streamlined or the traditional counseling arm. Those in the streamlined group will watch a brief educational video and have the option of immediate testing; The traditional counseling arm will instead be referred for a formal genetics consultation, after which they can choose to be tested. The primary outcome will be a patient reported outcome scale that assesses patient satisfaction with genetic counseling; patient anxiety and distress and cost effectiveness when using both strategies will also be evaluated. The study poses minimal risk to the patients that would not be encountered during standard of care genetic counseling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Either a) pathologically confirmed diagnosis of high-grade epithelial ovarian, fallopian or peritoneal cancer via biopsy or surgical pathology or b) cytologic diagnosis consistent with high-grade epithelial ovarian cancer.
- •Presenting to Duke gynecologic oncology clinic or collaborating institution for first outpatient visit following pathologic or cytologic diagnosis. If logistic constraints prevent the patient from being enrolled at her initial visit, she will be eligible for enrollment up to initiation of her fifth cycle of chemotherapy.
排除标准
- •Known family or personal history of an inherited cancer susceptibility mutation
- •Previously received genetic counseling or testing for an inherited cancer susceptibility mutation
- •Insurance provided by an insurance company that requires face-to-face genetic consultation prior to testing
- •Unable to read or speak English as study design includes video assisted educational materials in English
- •Blind or deaf as study design includes video assisted educational materials in English
结局指标
主要结局
Numeracy assessment
时间窗: Baseline
Numeracy as assessed by the Newest Vital Sign survey
Electronic Family History
时间窗: Completed at least 1 week prior to genetic sample being taken
Family cancer history up to past 3 generations
Demographic Information
时间窗: Baseline
Number of participants with children
Distress as measured by MICRA
时间窗: Approximately 7 days post-results disclosure
The multidimensional impact of cancer risk assessment questionnaire (MICRA) is a 25-question validated tool that measures the impact of result disclosure in patients, particularly markers of distress
Change in anxiety and depression as measured by the IES Scale
时间窗: Baseline, approximately 7 days post-education, and approximately 7 days post-results disclosure
The Impact of Events Scale (IES) has been used widely as a means of measuring patient distress (particularly intrusive thoughts or avoidance) over a defined incident. This evaluation will be used to identify trends in anxiety or depression in both arms throughout the education and testing process. In this trial, the "incident" will be described as "the risk of my cancer being hereditary."
次要结局
未报告次要终点