Visual Key Information for Cancer Clinical Trials

Overseen By Mary C Politi, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Under 18, Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how adding a Visual Key Information (VKI) page to consent forms affects participants' understanding and experience in joining cancer studies. It also examines research teams' perspectives on using these VKI pages. The trial compares standard consent forms with those enhanced by visual aids. English-speaking individuals involved in the consent process for a parent study are suitable participants. As an unphased study, this trial provides an opportunity to improve the consent process and enhance participant experience in future cancer research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Visual Key Information (VKI) page is safe for use in consent processes?

Research shows that using a Visual Key Information (VKI) page during the consent process is safe and helpful. Studies have found that these visual aids enhance understanding for those considering trial participation. By clarifying details, potential participants can make more informed decisions.

No safety concerns exist with VKI pages, as they are not a medical treatment. They present information visually to simplify consent forms. For those considering a trial with a VKI page, the goal is to improve clarity and understanding. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how adding a Visual Key Information (VKI) page to standard consent forms might improve the consent process for cancer clinical trials. Unlike traditional consent forms, which can be dense and hard to understand, the VKI page aims to present essential information in a clear and visually engaging way. This could make it easier for patients to understand the trial they're considering, potentially leading to better-informed decisions and greater participation in research. By assessing the opinions of research team members, the trial also aims to gather insights on how well the VKI page supports the consent process from a professional standpoint.

What evidence suggests that the Visual Key Information (VKI) page is effective for improving informed consent in cancer clinical trials?

Research has shown that Visual Key Information (VKI) pages can make consent forms easier to understand. In this trial, one arm will use standard consent forms with a VKI page, which previous studies have shown helps people better grasp trial details. This clearer understanding can remove barriers that might prevent participation. Another review found that these visual aids address issues with lengthy and complicated consent documents. Overall, VKI pages help participants feel more informed and comfortable about joining clinical trials. ^{1 6 7 8 9}

Who Is on the Research Team?

Mary C Politi, PhD

Principal Investigator

Washington University in St. Louis School of Public Health

Are You a Good Fit for This Trial?

This trial is for individuals participating in high-enrolling cancer studies who will experience the consent process. It's designed to assess how visual aids can improve understanding and satisfaction with informed consent.

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Consent Process

Participants experience the consent process with or without visual key information (VKI) pages

1 day

1 visit (in-person)

Follow-up

Participants' experiences and perceptions are assessed through surveys

9-13 months

What Are the Treatments Tested in This Trial?

Interventions

• Visual Key Information (VKI) page

Trial Overview

The study compares traditional written consent forms against enhanced forms with Visual Key Information (VKI) pages, aiming to see if VKIs improve participant experiences and perceptions of research teams.

How Is the Trial Designed?

Group I: Standard consent forms with a visual key information (VKI) page Experimental Treatment 2 Interventions

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

Group II: Research Team Members Experimental Treatment 2 Interventions

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

Group III: Standard consent forms Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06804837

Implement and Test Visual Consent Template and Process

After beginning in the standard consent arm, the research staff will then be randomized to the visual key information page arm at staggered time points to ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11927487/

a single-institution feasibility study and implementation testing

Visual KI templates can improve potential participant comprehension and in doing so, may reduce barriers to participation in research.

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07293520

Improving Consent Experiences in Clinical Trials

This is a study to evaluate the impact of evidence-based visual key information ... Behavioral : Visual Key Information (VKI) page. A VKI page ...

4.

digitalcommons.wustl.edu

digitalcommons.wustl.edu/cgi/viewcontent.cgi?article=5608&context=oa_4

Qualitative assessment of proposed visual key information ...

Visual key information pages offer a promising solution to long- standing informed consent challenges caused by lengthy, complex documents ...

5.

link.springer.com

link.springer.com/article/10.1186/s12910-025-01341-y

protocol for a stepped-wedge cluster randomized trial

The goal of this study is to assess the impact of the visual key information (KI) pages at both the research coordinator and participant level.

6.

bmjopen.bmj.com

bmjopen.bmj.com/content/15/3/e092185

a single-institution feasibility study and implementation ...

Visual KI templates can improve potential participant comprehension and in doing so, may reduce barriers to participation in research.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6599866/

Audio‐visual presentation of information for informed consent ...

The results from nine real clinical trials suggest that audio‐visual presentation of informed consent information may slightly improve knowledge of the parent ...

8.

cancer.gov

cancer.gov/research/participate/clinical-trials/safety

Are Clinical Trials Safe? - NCI

Your safety will be protected through the informed consent process, careful review and approval of the clinical trial protocol, and ongoing monitoring.

9.

fda.gov

fda.gov/media/149994/download

Core Patient-Reported Outcomes in Cancer Clinical Trials

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any ...