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临床试验/NCT01778582
NCT01778582已完成不适用

Perspective-taking, and Examining the Clinical Trial Informed Consent Process

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2012年11月15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
200
试验地点
1
主要终点
Assess knowledge of side effects to participate in a clinical trial

研究概览

简要总结

Background:

  • Very few people with cancer participate in clinical trials. Some are uncertain about the treatment, or are afraid of being treated like a guinea pig. They may also feel that they have inadequate information about the trial. One possible way of encouraging people to sign up for clinical trials is to improve the informed consent process. Researchers want to understand how people read and understand informed consent documents.

Objectives:

  • To study perspective taking, and to study how people understand the information and enrollment process for a clinical trial.

Eligibility:

  • Healthy volunteers at least 18 years of age.

Design:

  • This study will require one study visit.
  • Participants will watch one of four movie clips. They will be asked to respond to the film by looking at it from the main character s perspective. They will then answer questions about how the clips made them feel.
  • Participants will read a sample cancer clinical trial consent form on a computer. The computer will record their eye movements while they read the text. They will then be asked whether they remember the information in the consent form, and whether they would participate in the trial.
  • No treatment will be provided as part of this study.

详细描述

This study aims to examine perspective-taking and emotional states. The study also aims to examine information processing in the context of clinical trial consent forms, perceptions of risk of study side effects, hypothetical intentions to enroll, and satisfaction with the consent review process. Adult human subjects will be randomly assigned to watch a movie and take the main character s. Participants will also be asked to read a consent form for a clinical trial. Finally, they will be asked a series of questions about the consent form. I have also attached changes to the lay summary, which I had previously submitted, just to make sure that you have them.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Assess knowledge of side effects to participate in a clinical trial

时间窗: 1 year

Assess knowledge of hypothetical intentions to participate in a clinical trial

时间窗: 1 year

Assess knowledge of risk perceptions to participate in a clinical trial

时间窗: 1 year

次要结局

未报告次要终点

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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