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

Mayo Clinic

Status: Completed

Conditions: Cancer

Treatments: Other: 6,000 word consent form; Other: 2,000 word consent form; Other: 4,000 word consent form

Study type: Interventional

Funder types: Other

Identifiers

NCT04548063

20-007236

Details and patient eligibility

About

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.

Full 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.

Enrollment: 266 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient-reported history of cancer
• Patient is able to read English
• Patient-reported age of 18 years or older

Exclusion criteria

• None

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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266 participants in 3 patient groups

6,000 word consent form

Experimental group

Description:

Subjects who are receiving cancer therapy or have been treated for cancer in the past will be asked to review a mock consent form of approximately 6,000 words.

Treatment:

Other: 6,000 word consent form

4,000 word consent form

Experimental group

Description:

Subjects who are receiving cancer therapy or have been treated for cancer in the past will be asked to review a mock consent form of approximately 4,000 words.

Treatment:

Other: 4,000 word consent form

2,000 word consent form

Experimental group

Description:

Subjects who are receiving cancer therapy or have been treated for cancer in the past will be asked to review a mock consent form of approximately 2,000 words.

Treatment:

Other: 2,000 word consent form