Perspective-taking, and Examining the Clinical Trial Informed Consent Process
|ClinicalTrials.gov Identifier: NCT01778582|
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : May 18, 2018
- 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.
- To study perspective taking, and to study how people understand the information and enrollment process for a clinical trial.
- Healthy volunteers at least 18 years of age.
- 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.
|Condition or disease|
|Emotions Informed Consent|
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Perspective-taking, and Examining the Clinical Trial Informed Consent Process|
|Study Start Date :||November 15, 2012|
|Actual Primary Completion Date :||October 1, 2013|
|Actual Study Completion Date :||October 8, 2013|
- Assess knowledge of side effects to participate in a clinical trial [ Time Frame: 1 year ]
- Assess knowledge of risk perceptions to participate in a clinical trial [ Time Frame: 1 year ]
- Assess knowledge of hypothetical intentions to participate in a clinical trial [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778582
|United States, Maryland|
|National Cancer Institute (NCI), 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Rebecca A Ferrer, Ph.D.||National Cancer Institute (NCI)|