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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: 6,000 word consent form; Other: 2,000 word consent form; Other: 4,000 word consent form

• Registration Number: NCT04548063
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study Start: 2020-09-08
• Study First Submitted: 2020-09-09
• Study First Submitted QC: 2020-09-09
• Study First Posted: 2020-09-14
• Primary Completion: 2020-11-06
• Study Completion: 2020-11-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 266

Inclusion Criteria

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

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Exclusion Criteria

• None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
6,000 word consent form	6,000 word consent form	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.
2,000 word consent form	2,000 word consent form	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.
4,000 word consent form	4,000 word consent form	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.

Primary Outcome Measures

Name	Time	Method
Decision to enroll	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States