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NCT04548063 Clinical Trial

Consent Forms in Cancer Research: Examining the Effect of Length on Readability

Cancer Clinical Trial

Official title:
Consent Forms in Cancer Research: Examining the Effect of Length on Readability

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04548063
Other study ID # 20-007236
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 8, 2020
Est. completion date November 4, 2024

Study information
Verified date September 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 266
Est. completion date November 4, 2024
Est. primary completion date July 4, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient-reported history of cancer - Patient is able to read English - Patient-reported age of 18 years or older Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 6,000 word consent form
Mock consent form with consistent content in approximately 6,000 word length.
• 4,000 word consent form
Mock consent form with consistent content in approximately 4,000 word length.
• 2,000 word consent form
Mock consent form with consistent content in approximately 2,000 word length.

Locations
Country Name City State
United States Mayo Clinic in Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Decision to enroll 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. Through study completion, approximately 1 hour
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