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

NCT04548063 | Completed

• 1 other identifier: 20-007236
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Other: 6,000 word consent form

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.

Other: 4,000 word consent form

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.

Other: 2,000 word consent form

Interventions

6,000 word consent form OTHER

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

6,000 word consent form

4,000 word consent form OTHER

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

4,000 word consent form

2,000 word consent form OTHER

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

2,000 word consent form

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 34125586 BACKGROUND

• 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.

  PMID: 35756962 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Neoplasms

Study Officials

• Aminah Jatoi, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 14, 2020
• Study Start: September 8, 2020
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)