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临床试验/NCT05805982
NCT05805982已完成不适用

Randomized Non Inferiority Trial of Educational Video Versus In-person Genetic Counseling for Hereditary Cancer

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran1 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2020年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
251
试验地点
1
主要终点
Genetic testing acceptance

研究概览

简要总结

The identification of mutations in cancer susceptibility genes is important as it makes it possible to recommend specific cancer treatments, implement risk reduction strategies or early detection of cancer, and identify family members at risk. The guidelines for evaluating patients who are candidates for genetic testing recommend pre-test genetic counseling. However, the limited number of specialists trained to provide genetic counseling worldwide, and particularly in developing countries such as Mexico, makes it difficult to implement such recommendations. The present proposal aims to compare, through a randomized non-inferiority study, a pre-test education strategy using a pre-recorded video against in-person counseling. This strategy could potentially increase access in places with limited resources.

The general hypothesis of the research is that patients who are candidates for cancer genetic susceptibility testing who receive pre-test education via video will consent to genetic testing in the same proportion as those who receive it during an in-person visit.

The specific objectives of the study include: 1) to compare the proportion of patients who are tested in both groups; 2) to assess knowledge about hereditary cancer in both groups after the intervention; 3) assess anxiety symptoms in both groups after the intervention; and 4) assess satisfaction with the information received during the intervention.Patients >18 years of age who meet the criteria for genetic testing to evaluate genetic cancer susceptibility genes and who have not previously undergone genetic testing or genetic counseling will be invited. The intervention group will receive education via pre-recorded video and the control group will receive genetic counseling during an in-person consultation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
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

  • •Meet cancer genetic testing criteria

排除标准

  • •Had a genetic testing before
  • •Had genetic counseling before

研究组 & 干预措施

Educational Video

Experimental

The patient will watch a 15-minute video on an electronic tablet that includes the following items:

  • What is hereditary cancer?
  • Inheritance risk
  • Who are candidates for a genetic test?
  • What is a genetic testing and how can it help?
  • What types of results can be expected from genetic testing?
  • Reactions to the result of the genetic test
  • Clinical care according to the results
  • Any common questions? When the patient finish watching the video, he/she would have the opportunity to resolve any doubts.

干预措施: Educational Video (Behavioral)

In-Person genetic counseling

Active Comparator

Patients will receive pre-test genetic counseling in person with a specialist using the usual protocols existing at the Institute and systematically includes the following:

Family history of cancer Personal cancer risk assessment Education on inheritance and disease expression Types of tests and results (positive, negative and variants of uncertain significance).

Limitations of the genetic study Preparation of possible outcomes according to results Risks Additional information: confidentiality of the results, costs and test options. Opportunity will be given to resolve doubts

干预措施: In person genetic cancer counseling (Behavioral)

结局指标

主要结局

Genetic testing acceptance

时间窗: up to 12 weeks

Proportion of patients that accept to undergo a genetic testing

次要结局

  • Genetic cancer knowledge change (pre and post intervention)(up to 24 hours after intervention)
  • Anxiety level (pre and post intervention)(up to 24 hours after intervention)

研究者

发起方
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanin Chavarri Guerra

Principal Investigator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

研究点 (1)

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