Video Education With Result Dependent dIsclosure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,020
- 试验地点
- 1
- 主要终点
- Video Education Acceptability (Qualitative Interview Study)
研究概览
简要总结
The overall study objective of this trial study is to identify and evaluate strategies to improve the accessibility of the video education with result dependent disclosure (VERDI) model, increasingly utilized as a pre-genetic testing (pretest) education alternative in clinical practice, to better serve a more diverse patient population at risk for hereditary cancers.
详细描述
This study consists of two parts:
-
Qualitative assessment:
-
This part of the research study involves watching a brief educational video about genetic testing for inherited cancer risk (about 8 minutes) before completing a short interview by video or telephone with trained researchers. This interview will be digitally recorded for later review. Participation in the study will be considered complete after the interview is finished. The qualitative assessment study will recruit 20 total participants.
-
The data gathered from this study will inform the refinement and adaptation of the VERDI model for the subsequent randomized controlled trial.
-
Randomized control trial:
-
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling in 1000 participants
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
- •Age ≥ 18 years
- •Current or prior diagnosis of breast cancer, ovarian cancer, pancreatic cancer, prostate cancer, colorectal cancer, renal cancer, melanoma, or sarcoma
- •Ability to understand spoken or written English or Spanish in a healthcare context
- •Ability to understand and the willingness to sign a written informed consent document
- •Black or Latinx (qualitative assessment study only)
排除标准
- •Prior cancer genetic testing
- •Prior germline genetic testing
- •Active hematologic malignancy (e.g. chronic lymphocytic leukemia)
- •Currently pregnant
- •Currently incarcerated
研究组 & 干预措施
QUALITATIVE ASSESSMENT
This part of the research study involves watching a brief educational video about genetic testing for inherited cancer risk (about 8 minutes) before completing a short interview by video or telephone with trained researchers. This interview will be digitally recorded for later review.
It is expected that about 20 people will take part in this part of the research study.
In the larger part of the study that will happen after this part of the study, it is expected 1000 people will participate.
干预措施: Video Education (Behavioral)
RCT-VERDI
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
干预措施: Video Education (Behavioral)
RCT-Genetic Counseling
A randomized controlled trial (RCT) will evaluate the VERDI model vs. standard genetic counseling
干预措施: Genetic Counseling (Behavioral)
结局指标
主要结局
Video Education Acceptability (Qualitative Interview Study)
时间窗: 3 Weeks
Pre- and post-test of knowledge of hereditary cancer risk and cancer genetic counseling with qualitative patient interview question domains and instruments to assess understanding of language and imagery of video education as correlated with measures of health literacy.
次要结局
未报告次要终点
研究者
Huma Rana, MD
Principal Investigator
Dana-Farber Cancer Institute