Community Enhanced Virtual Informed Consent

NCT07805083 — Not applicable, Recruiting, 600 participants, Mayo Clinic
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Exploring Health Communication Message Factors That Influence Cancer Research Recruitment

RegistryNCT07805083, acronym CEVIC
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, health services research
Enrollment600 (Estimated)
SponsorMayo Clinic (Other)
ConditionsHematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
InterventionsEducational Cancer Intervention, ICF Text Version 1, ICF Text Version 2, ICF Video Version 1, ICF Video Version 2, ICF Video Version 3, ICF Video Version 4, Survey Administration (Behavioral, other)
Datesstart 2026-07-21, primary completion 2027-07-20 (estimated), completion 2029-07-20 (estimated), first posted 2026-09-04, last updated 2026-09-08
Locations1 site in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Hematopoietic and Lymphatic System Neoplasm All trials for Malignant Solid Neoplasm All trials of Educational Cancer Intervention All trials of ICF Text Version 1

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Arm I - ICF Text Version 1ExperimentalBehavioral: Educational Cancer Intervention; Other: ICF Text Version 1; Other: Survey AdministrationPatients 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 2ExperimentalBehavioral: Educational Cancer Intervention; Other: ICF Text Version 2; Other: Survey AdministrationPatients 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 1ExperimentalBehavioral: Educational Cancer Intervention; Other: ICF Video Version 1; Other: Survey AdministrationPatients 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 2ExperimentalBehavioral: Educational Cancer Intervention; Other: ICF Video Version 2; Other: Survey AdministrationPatients 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 3ExperimentalBehavioral: Educational Cancer Intervention; Other: ICF Video Version 3; Other: Survey AdministrationPatients 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 4ExperimentalBehavioral: Educational Cancer Intervention; Other: ICF Video Version 4; Other: Survey AdministrationPatients 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.
  • Educational Cancer Intervention (Behavioral), also known as Behavioural: Participants will view informed consent messaging presented in different formats
  • ICF Text Version 1 (Other), also known as Formal Consent, Informed Consent, INFORMED CONSENT OBTAINED: Receive a text-based informed consent form
  • ICF Text Version 2 (Other), also known as Formal Consent, Informed Consent, INFORMED CONSENT OBTAINED: Receive an adapted text-based informed consent form
  • ICF Video Version 1 (Other), also known as Formal Consent, Informed Consent, INFORMED CONSENT OBTAINED: Receive a video-based informed consent form delivered by virtual human #1
  • ICF Video Version 2 (Other), also known as Formal Consent, Informed Consent, INFORMED CONSENT OBTAINED: Receive a video-based informed consent form delivered by virtual human #2
  • ICF Video Version 3 (Other), also known as Formal Consent, Informed Consent, INFORMED CONSENT OBTAINED: Receive a video-based informed consent form delivered by virtual human #3
  • ICF Video Version 4 (Other), also known as Formal Consent, Informed Consent, INFORMED CONSENT OBTAINED: Receive a video-based informed consent form delivered by virtual human #4
  • Survey Administration (Other): Ancillary studies

+Outcome measures

Primary outcomes

  • Self-efficacy (Aim 1) [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.
  • Trustworthiness (Aim 2) [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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

FacilityCityCountryStatus
Mayo Clinic in FloridaJacksonville, FloridaUnited StatesRecruiting

+Investigators