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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01778582
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : June 20, 2018
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


- 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

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. Assess knowledge of side effects to participate in a clinical trial [ Time Frame: 1 year ]
  2. Assess knowledge of risk perceptions to participate in a clinical trial [ Time Frame: 1 year ]
  3. Assess knowledge of hypothetical intentions to participate in a clinical trial [ Time Frame: 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Participants who are currently being treated for cancer will be excluded because their experience of a cancer clinical trial consent form would be qualitatively different from a noncancer patient s experience. Similarly, because individuals who have participated previously in a clinical trial might have a different perspective on participation or let previous experienced bias their perceptions of the hypothetical clinical trial context, we will also exclude individuals who have previously participated in a medical clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01778582

United States, Maryland
National Cancer Institute (NCI), 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Rebecca A Ferrer, Ph.D. National Cancer Institute (NCI)