Community Enhanced Virtual Informed Consent

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT07805083
Status
Recruiting
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Conditions

  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Behavioral Intervention — BEHAVIORAL
    View cancer messaging
  • ICF Text Version 1 — OTHER
    Receive a text-based informed consent form
  • ICF Text Version 2 — OTHER
    Receive an adapted text-based informed consent form
  • ICF Video Version 1 — OTHER
    Receive a video-based informed consent form delivered by virtual human #1
  • ICF Video Version 2 — OTHER
    Receive a video-based informed consent form delivered by virtual human #2
  • ICF Video Version 3 — OTHER
    Receive a video-based informed consent form delivered by virtual human #3
  • ICF Video Version 4 — OTHER
    Receive a video-based informed consent form delivered by virtual human #4
  • Survey Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

First listed
Sep 4, 2026
Start date
Jul 21, 2026
Status verified
Sep 2026
Primary completion
Jul 20, 2027
Completion
Jul 20, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Self-efficacy (Aim 1) [ Time Frame: Baseline (immediately following intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
L. ETCH Lab
[email protected]
904-953-5375
Janice L. Krieger, PhD (PRINCIPAL_INVESTIGATOR)

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