MedDataX Logo

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

NCT ID: NCT01778582

Last Updated: 2019-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-15

Study Completion Date

2013-10-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emotions Informed Consent

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Emotion Informed Consent

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rebecca A Ferrer, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Angie AD, Connelly S, Waples EP, Kligyte V. The influence of discrete emotions on judgement and decision-making: a meta-analytic review. Cogn Emot. 2011 Dec;25(8):1393-422. doi: 10.1080/02699931.2010.550751. Epub 2011 May 24.

Reference Type BACKGROUND
PMID: 21500048 (View on PubMed)

Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: consent to research and the therapeutic misconception. Hastings Cent Rep. 1987 Apr;17(2):20-4.

Reference Type BACKGROUND
PMID: 3294743 (View on PubMed)

Arora A, Rajagopalan S, Shafiq N, Pandhi P, Bhalla A, Dhibar DP, Malhotra S. Development of tool for the assessment of comprehension of informed consent form in healthy volunteers participating in first-in-human studies. Contemp Clin Trials. 2011 Nov;32(6):814-7. doi: 10.1016/j.cct.2011.05.012. Epub 2011 Jun 1.

Reference Type BACKGROUND
PMID: 21664491 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13-C-N021

Identifier Type: -

Identifier Source: secondary_id

999913021

Identifier Type: -

Identifier Source: org_study_id