Improving Consent Experiences in Clinical Trials

The Washington University

Status: Withdrawn

Conditions: Cancer

Treatments: Behavioral: Visual Key Information (VKI) page; Behavioral: Standard Consent Form

Study type: Interventional

Funder types: Other

Identifiers

NCT07293520

202511065

Details and patient eligibility

About

This is a study to evaluate the impact of evidence-based visual key information (VKI) pages on participant's experiences with informed consent for research, enrollment in high-accruing studies that choose to use VKIs as part of their consent process, and research team perceptions of the implementation potential of VKIs in studies. Unlike in previous pilots conducted at Siteman Cancer Center, this study will assess changes in outcomes before and after a VKI is implemented in a study consent process.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Patient Eligibility Criteria:

• Patient must be 18 years or older
• Patients must be English-speaking
• Able to understand an IRB-approved written consent document
• Must go through the consent process for one of the parent studies

Research Team Eligibility Criteria:

• Member of a parent study research team
• Engaged in the study consent processes, including creating and reviewing consents or enrolling participants

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Standard consent forms

Active Comparator group

Description:

The approved standard consent form will be used during the consent processes.

Treatment:

Behavioral: Standard Consent Form

Standard consent forms with a visual key information (VKI) page

Experimental group

Description:

The approved standard consent form with a VKI page will be used during the consent processes.

Treatment:

Behavioral: Standard Consent Form

Behavioral: Visual Key Information (VKI) page

Research Team Members

Experimental group

Description:

Members of the parent study's research team will complete the research team survey to assess opinions on consent process.

Treatment:

Behavioral: Standard Consent Form

Behavioral: Visual Key Information (VKI) page