Community Enhanced Virtual Informed Consent (CEVIC)
September 3, 2026 updated by: Mayo Clinic
Exploring Health Communication Message Factors That Influence Cancer Research Recruitment
The goal of this clinical trial is to examine perceptions of virtual human communicators and cancer research recruitment messages.
This study will also examine how different informed consent approaches influence decisions to participate in research.
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Estimated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: ETCH Lab
- Phone Number: 904-953-5375
- Email: ETCH@mayo.edu
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Recruiting
- Mayo Clinic in Florida
-
Principal Investigator:
- Janice L. Krieger, PhD
-
Contact:
- L. ETCH Lab
- Phone Number: 904-953-5375
- Email: ETCH@mayo.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Able to speak, read, or understand English sufficiently to provide informed consent
- 18 years of age or older
- White or Black
- Living in the United States
Exclusion Criteria:
- Unable to speak, read, or understand English sufficiently to provide informed consent
- Inability on the part of the patient to understand the informed consent or be compliant with the protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm I - ICF Text Version 1
Patients receive a standard of care-based informed consent form.
Patients then complete an educational cancer messaging intervention where patients view images of virtual humans, view cancer recruitment study message frames and view images of hospital/institutional single-endorsement and multi-endorsement cancer study recruitment advertisements and rate them for credibility.
|
Ancillary studies
Receive a text-based informed consent form
Other Names:
Participants will view informed consent messaging presented in different formats
Other Names:
|
|
Experimental: Arm II - ICF Text Version 2
Patients receive a modified community-enhanced language text-based informed consent form.
Patients then complete an educational cancer messaging intervention where patients view images of virtual humans, view cancer recruitment study message frames and view images of hospital/institutional single-endorsement and multi-endorsement cancer study recruitment advertisements and rate them for credibility.
|
Ancillary studies
Receive an adapted text-based informed consent form
Other Names:
Participants will view informed consent messaging presented in different formats
Other Names:
|
|
Experimental: Arm III - ICF Video Version 1
Patients receive a video-based community-enhanced informed consent form delivered by a virtual human educator (Physician A).
The virtual human explains the informed consent form content using the language from Arm II.
Patients then complete an educational cancer messaging intervention where patients view images of virtual humans, view cancer recruitment study message frames and view images of hospital/institutional single-endorsement and multi-endorsement cancer study recruitment advertisements and rate them for credibility.
|
Ancillary studies
Receive a video-based informed consent form delivered by virtual human #1
Other Names:
Participants will view informed consent messaging presented in different formats
Other Names:
|
|
Experimental: Arm IV - ICF Video Version 2
Patients receive a video-based community-enhanced informed consent form delivered by a virtual human educator (Physician B).
The virtual human explains the informed consent form content using the language from Arm II.
Patients then complete an educational cancer messaging intervention where patients view images of virtual humans, view cancer recruitment study message frames and view images of hospital/institutional single-endorsement and multi-endorsement cancer study recruitment advertisements and rate them for credibility.
|
Ancillary studies
Receive a video-based informed consent form delivered by virtual human #2
Other Names:
Participants will view informed consent messaging presented in different formats
Other Names:
|
|
Experimental: Arm V - ICF Video Version 3
Patients receive a video-based community-enhanced informed consent form delivered by a virtual human educator (Community Member A).
The virtual human explains the informed consent form content using the language from Arm II.
Patients then complete an educational cancer messaging intervention where patients view images of virtual humans, view cancer recruitment study message frames and view images of hospital/institutional single-endorsement and multi-endorsement cancer study recruitment advertisements and rate them for credibility.
|
Ancillary studies
Receive a video-based informed consent form delivered by virtual human #3
Other Names:
Participants will view informed consent messaging presented in different formats
Other Names:
|
|
Experimental: Arm VI - ICF Video Version 4
Patients receive a video-based community-enhanced informed consent form delivered by a virtual human educator (Community Member B).
The virtual human explains the informed consent form content using the language from Arm II.
Patients then complete an educational cancer messaging intervention where patients view images of virtual humans, view cancer recruitment study message frames and view images of hospital/institutional single-endorsement and multi-endorsement cancer study recruitment advertisements and rate them for credibility.
|
Ancillary studies
Receive a video-based informed consent form delivered by virtual human #4
Other Names:
Participants will view informed consent messaging presented in different formats
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-efficacy (Aim 1)
Time Frame: Baseline (immediately following intervention)
|
Assessed by 3 questions in the study-specific survey.
The questions are answered on a scale of 1 (strongly disagree) to 5=strongly agree.
Higher scores indicate greater feelings of self-efficacy.
|
Baseline (immediately following intervention)
|
|
Trustworthiness (Aim 2)
Time Frame: Baseline (immediately following intervention)
|
Assessed by a study-specific survey asking participants to rate the intervention on a scale of 1 (untrustworthy) to 7 (trustworthy).
Higher scores indicate greater perception of trustworthiness.
|
Baseline (immediately following intervention)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Janice L. Krieger, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 21, 2026
Primary Completion (Estimated)
July 20, 2027
Study Completion (Estimated)
July 20, 2029
Study Registration Dates
First Submitted
September 1, 2026
First Submitted That Met QC Criteria
September 1, 2026
First Posted (Actual)
September 4, 2026
Study Record Updates
Last Update Posted (Actual)
September 8, 2026
Last Update Submitted That Met QC Criteria
September 3, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-000655
- NCI-2026-05713 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.