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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Other: 6,000 word consent form
* Other: 4,000 word consent form
* Other: 2,000 word consent form


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient-reported history of cancer Patient is able to read English Patient-reported age of 18 years or older Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 6,000 word consent form<br>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. | Other: 6,000 word consent form<br>* Mock consent form with consistent content in approximately 6,000 word length.<br>|
| Experimental: 4,000 word consent form<br>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. | Other: 4,000 word consent form<br>* Mock consent form with consistent content in approximately 4,000 word length.<br>|
| Experimental: 2,000 word consent form<br>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. | Other: 2,000 word consent form<br>* Mock consent form with consistent content in approximately 2,000 word length.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |