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

Completed

• Conditions: Emotions; Informed Consent

• Registration Number: NCT01778582
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

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.

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 Timeline

• Study Start: 2012-11-15
• Study First Submitted: 2013-01-26
• Study First Submitted QC: 2013-01-26
• Study First Posted: 2013-01-29
• Primary Completion: 2013-10-01
• Study Completion: 2013-10-08
• Status Verified: 2015-09-18
• Last Update Submitted: 2019-12-06
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess knowledge of side effects to participate in a clinical trial	1 year
Assess knowledge of hypothetical intentions to participate in a clinical trial	1 year
Assess knowledge of risk perceptions to participate in a clinical trial	1 year

Trial Locations

Locations (1)

National Cancer Institute (NCI), 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States