Improving Consent Experiences in Clinical Trials

Improving Consent Experiences in Clinical Trials at Siteman Cancer Center

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.

Study Overview

• Status: Withdrawn
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Standard Consent Form; Behavioral: Visual Key Information (VKI) page

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Contact: Mary C Politi, PhD; Phone Number: 314-935-3802; Email: mpoliti@wustl.edu
      • Contact: Eliana Goldstein; Phone Number: 314-935-7234; Email: goldsteinelianac@wustl.edu
      • Principal Investigator: Mary C Politi, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard consent forms; The approved standard consent form will be used during the consent processes.	Behavioral: Standard Consent Form; The IRB-approved consent form will be used by research team staff during consenting process of participants for parent studies.
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.	Behavioral: Standard Consent Form; The IRB-approved consent form will be used by research team staff during consenting process of participants for parent studies.; 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.
Experimental: Research Team Members; Members of the parent study's research team will complete the research team survey to assess opinions on consent process.	Behavioral: Standard Consent Form; The IRB-approved consent form will be used by research team staff during consenting process of participants for parent studies.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's knowledge of consent	Knowledge of consent will be measured by patient's responses to 6-items on the patient consent experience survey. The 6-items are customized for each parent study and have three answers for patient to choose: true, false, and unsure. Responses will be reported via descriptive statistics and between group differences will be examined via chi-square tests.	Time of consent completion for parent study (day 1)
Patient's anxiety about enrolling	Anxiety about enrolling will be captured by patient's answers to a single item on the patient consent experience survey adapted from the Amsterdam Preoperative Anxiety and Information Scale (APAIS). The item is measured by a 5-point Likert scale as follows: Not at all, A little, Somewhat, A lot, and Extremely. Responses be will scored as appropriate for the validated measure and between group differences will be examined via t-tests.	Time of consent completion for parent study (day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's trust in information	Patient's trust in information will be measured by a single-item on the patient consent experience survey adapted from the Health Information National Trends Survey (HINTS) from the National Cancer Institute. The item is a 5-point scale with answers as follows: Not at all, Slightly, Moderately, Very, and Extremely. Responses will be scored as appropriate for the validated measure and between group differences will be examined via t-tests.	Time of consent completion for parent study (day 1)
Patient's perceptions of patient centered care	Perception of patient-centered care (PCC) will be measured by three items on the patient consent experience survey which are adapted from the Health Information National Trends Survey (HINTS) from the National Cancer Institute. The items are a 4-point scale as follows: Always, Usually, Sometimes, and Never. Responses will be scored as appropriate for the validated measure and between group differences will be examined via t-tests.	Time of consent completion for parent study (day 1)
Parent study enrollment rates	Enrollment rates will be measured by total number of patients enrolled in each parent study. Responses will be reported via descriptive statistics and between group differences will be examined via t-tests.	Completion of enrollment (estimated total time is 9-13 months)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Mary C Politi, PhD, Washington University in St. Louis School of Public Health

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 5, 2025
• First Submitted That Met QC Criteria: December 5, 2025
• First Posted (Estimated): December 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Informed Consent; Research Ethics; Key information
• Additional Relevant MeSH Terms: Neoplasms; Investigative Techniques; Chemistry Techniques, Analytical; Electrochemical Techniques; Electrophoresis; Electrophoresis, Polyacrylamide Gel
• Other Study ID Numbers: 202511065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No