Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01778582
First received: January 26, 2013
Last updated: October 17, 2014
Last verified: September 2014
  Purpose

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.

Condition
Emotions
Informed Consent

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Perspective-taking, and Examining the Clinical Trial Informed Consent Process

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Assess knowledge of side effects to participate in a clinical trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Assess knowledge of risk perceptions to participate in a clinical trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Assess knowledge of hypothetical intentions to participate in a clinical trial [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION AND EXCLUSION CRITERIA:

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01778582

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