Community Enhanced Virtual Informed Consent
CEVIC
Exploring Health Communication Message Factors That Influence Cancer Research Recruitment
2 other identifiers
interventional
600
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 21, 2026
CompletedFirst Submitted
Initial submission to the registry
September 1, 2026
CompletedFirst Posted
Study publicly available on registry
September 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 20, 2029
September 8, 2026
September 1, 2026
12 months
September 1, 2026
September 3, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Self-efficacy (Aim 1)
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)
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)
Study Arms (6)
Arm I - ICF Text Version 1
EXPERIMENTALPatients 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.
Arm II - ICF Text Version 2
EXPERIMENTALPatients 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.
Arm III - ICF Video Version 1
EXPERIMENTALPatients 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.
Arm IV - ICF Video Version 2
EXPERIMENTALPatients 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.
Arm V - ICF Video Version 3
EXPERIMENTALPatients 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.
Arm VI - ICF Video Version 4
EXPERIMENTALPatients 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.
Interventions
Receive an adapted text-based informed consent form
Receive a video-based informed consent form delivered by virtual human #2
Receive a text-based informed consent form
Receive a video-based informed consent form delivered by virtual human #1
Participants will view informed consent messaging presented in different formats
Receive a video-based informed consent form delivered by virtual human #3
Receive a video-based informed consent form delivered by virtual human #4
Ancillary studies
Eligibility Criteria
You may qualify if:
- Able to speak, read, or understand English sufficiently to provide informed consent
- years of age or older
- White or Black
- Living in the United States
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janice L. Krieger, PhD
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2026
First Posted
September 4, 2026
Study Start
July 21, 2026
Primary Completion (Estimated)
July 20, 2027
Study Completion (Estimated)
July 20, 2029
Last Updated
September 8, 2026
Record last verified: 2026-09