Recruiting

Informed Consent

Sponsor:

Washington University School of Medicine

Code:

NCT07293520

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Standard Consent Form

Visual Key Information (VKI) page

Study Details

Brief summary:

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.

Conditions

Cancer

Study ID

NCT07293520

Start date

Nov 25, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Standard consent forms

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

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

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

experimental: Research Team Members

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

Interventions

Standard Consent Form

The IRB-approved consent form will be used by research team staff during consenting process of participants for parent studies.

Visual Key Information (VKI) page

A VKI page will be designed for each parent study based on study materials and current consent document. The VKI will be implemented in the consent material for the study.

Primary outcome measure

  • Patient's knowledge of consent [ Time Frame: Time of consent completion for parent study (day 1) ]
  • Patient's anxiety about enrolling [ Time Frame: Time of consent completion for parent study (day 1) ]

Central Contacts and Locations

Central contacts

Mary C Politi, PhD

314-935-3802mpoliti@wustl.edu

Eliana Goldstein, MPH

314-935-7234goldsteinelianac@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Mary C Politi, PhD

314-935-3802mpoliti@wustl.edu

Eliana Goldstein

314-935-7234goldsteinelianac@wustl.edu

Principal Investigator:

Mary C Politi, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Dec 19, 2025

Last verified

Dec, 2025

Keywords

  • Informed Consent
  • Key information
  • Research Ethics

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2025-12-19.