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


N/A
18 Years
N/A
Open (Enrolling)
Both
Emotions, Informed Consent

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Trial Information

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


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.

Inclusion 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.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

Assess knowledge of side effects to participate in a clinical trial

Outcome Time Frame:

1 year

Principal Investigator

Rebecca A Ferrer, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

999913021

NCT ID:

NCT01778582

Start Date:

November 2012

Completion Date:

October 2013

Related Keywords:

  • Emotions
  • Informed Consent
  • Emotion
  • Informed Consent

Name

Location

National Cancer Institute (NCI), 9000 Rockville PikeBethesda, Maryland  20892