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

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT04548063

Collaborator

(none)

266

Enrollment

Location

Arms

45.8

Anticipated Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Other: 6,000 word consent form Other: 4,000 word consent form Other: 2,000 word consent form	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

266 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 8, 2020

Anticipated Primary Completion Date :

Jul 4, 2023

Anticipated Study Completion Date :

Jul 4, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 6,000 word consent form Mock consent form with consistent content in approximately 6,000 word length.
Experimental: 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.	Other: 4,000 word consent form Mock consent form with consistent content in approximately 4,000 word length.
Experimental: 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.	Other: 2,000 word consent form Mock consent form with consistent content in approximately 2,000 word length.

Arm

Intervention/Treatment

Experimental: 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.

Other: 6,000 word consent form

Mock consent form with consistent content in approximately 6,000 word length.

Experimental: 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.

Other: 4,000 word consent form

Mock consent form with consistent content in approximately 4,000 word length.

Experimental: 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.

Other: 2,000 word consent form

Mock consent form with consistent content in approximately 2,000 word length.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Mayo Clinic

Investigators

Principal Investigator: Aminah Jatoi, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Aminah Jatoi, M.D., Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT04548063

Other Study ID Numbers:

20-007236

First Posted:

Sep 14, 2020

Last Update Posted:

Mar 31, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 31, 2022