Randomized, Double-Blind Trial on the Impact of Word Count in Cancer Clinical Trial Consent Forms.

ABSTRACT:

Purpose

This randomized, double-blind study sought to understand whether cancer clinical trial consent form verbosity detracts from patients' decision making on trial enrollment.

Methods

This trial tested mock consent forms of 2,000, 4,000, and 6,000 words. The first two comprised the two experimental arms and the third the control arm. Phase II was conducted to identify the promising arm, which, in phase III, was compared with the control arm. Each consent form described the same trial. Eligible adult patients reported a cancer history and English literacy. The primary end point used a patient-reported Likert scale to assess the relationship between information in the consent form and trial decision making.

Results

In phase II, 93 patients were accrued and prompted t

SUBMITTER: Almodallal Y 

PROVIDER: S-EPMC9810143 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature