Emotions Clinical Trial
Official title:
Perspective-taking, and Examining the Clinical Trial Informed Consent Process
Verified date | September 18, 2015 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | October 8, 2013 |
Est. primary completion date | October 1, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Cancer Institute (NCI), 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
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. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess knowledge of side effects to participate in a clinical trial | 1 year | ||
Primary | Assess knowledge of risk perceptions to participate in a clinical trial | 1 year | ||
Primary | Assess knowledge of hypothetical intentions to participate in a clinical trial | 1 year |
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