Improving Consent Experiences in Clinical Trials

NCT ID: NCT07293520

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-25

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer

Keywords

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Informed Consent Key information Research Ethics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard consent forms

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

Group Type ACTIVE_COMPARATOR

Standard Consent Form

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Standard Consent Form

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Research Team Members

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

Group Type EXPERIMENTAL

Standard Consent Form

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Interventions

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Standard Consent Form

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary C Politi, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University in St. Louis School of Public Health

Countries

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United States

Related Links

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http://siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

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202511065

Identifier Type: -

Identifier Source: org_study_id