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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6,000 word consent form | Experimental | 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. |
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| 4,000 word consent form | Experimental | 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. |
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| 2,000 word consent form | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 6,000 word consent form | Other | Mock consent form with consistent content in approximately 6,000 word length. |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aminah Jatoi, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34125586 | Background | Almodallal Y, Duong Q, Satele D, Novotny P, Cook KD, Chauhan C, Daiss MK, Le-Rademacher J, Looker S, Martin N, Smestad MF, Winham SJ, Mandrekar SJ, Jatoi A. Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms. JCO Oncol Pract. 2021 Oct;17(10):e1460-e1472. doi: 10.1200/OP.21.00071. Epub 2021 Jun 14. | |
| 35756962 |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| 4,000 word consent form | Other | Mock consent form with consistent content in approximately 4,000 word length. |
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| 2,000 word consent form | Other | Mock consent form with consistent content in approximately 2,000 word length. |
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| Wieland J, Satele D, Almodallal Y, Novotny P, Pritzl SL, Mandrekar SJ, Jatoi A. Succinct Cancer Clinical Trial Consent Forms in Rural Patients With Cancer: A Secondary Analysis of a Randomized, Double-Blinded study. J Patient Exp. 2022 Jun 22;9:23743735221107242. doi: 10.1177/23743735221107242. eCollection 2022. |