Consent Forms in Cancer Research: Examining the Effect of Length on Readability
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Mayo Clinic
- Enrollment
- 266
- Locations
- 1
- Primary Endpoint
- Decision to enroll
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Researchers are using mock consent forms to see if wordiness has any effect on patients' understanding and willingness to sign up for a cancer clinical trial.
Detailed Description
This study will determine whether there is a relationship between wordiness of a consent form and whether or not the consent form helped the patient decide to enroll in a clinical trial. This study will also determine whether wordiness of a consent form is associated with patients' willingness to sign the consent form.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient-reported history of cancer
- •Patient is able to read English
- •Patient-reported age of 18 years or older
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Decision to enroll
Time Frame: Through study completion, approximately 1 hour
Number of participants to indicate on the self-reported patient questionnaire that the information provided in the consent form helped make a decision about whether or not to enroll in the trial. This is defined as a response of 1 or 2 on the Likert scale of 1=strongly agree and 5= strongly disagree for information in the consent form was helpful to the decision to join the study.