Community Enhanced Virtual Informed Consent

Purpose

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.

Conditions

  • Hematopoietic and Lymphatic System Neoplasm
  • Malignant Solid Neoplasm

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Health Services Research
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: Behavioral Intervention
    View cancer messaging
    Other names:
    • Behavior Conditioning Therapy
    • Behavior Modification
    • Behavior or Life Style Modifications
    • Behavior Therapy
    • Behavioral Interventions
    • Behavioral Modification
    • Behavioral Therapy
    • Behavioral Treatment
    • Behavioral Treatments
    • Behavioural
  • Other: ICF Text Version 1
    Receive a text-based informed consent form
    Other names:
    • Formal Consent
    • Informed Consent
    • INFORMED CONSENT OBTAINED
  • Other: Survey Administration
    Ancillary studies
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.
  • Behavioral: Behavioral Intervention
    View cancer messaging
    Other names:
    • Behavior Conditioning Therapy
    • Behavior Modification
    • Behavior or Life Style Modifications
    • Behavior Therapy
    • Behavioral Interventions
    • Behavioral Modification
    • Behavioral Therapy
    • Behavioral Treatment
    • Behavioral Treatments
    • Behavioural
  • Other: ICF Text Version 2
    Receive an adapted text-based informed consent form
    Other names:
    • Formal Consent
    • Informed Consent
    • INFORMED CONSENT OBTAINED
  • Other: Survey Administration
    Ancillary studies
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.
  • Behavioral: Behavioral Intervention
    View cancer messaging
    Other names:
    • Behavior Conditioning Therapy
    • Behavior Modification
    • Behavior or Life Style Modifications
    • Behavior Therapy
    • Behavioral Interventions
    • Behavioral Modification
    • Behavioral Therapy
    • Behavioral Treatment
    • Behavioral Treatments
    • Behavioural
  • Other: ICF Video Version 1
    Receive a video-based informed consent form delivered by virtual human #1
    Other names:
    • Formal Consent
    • Informed Consent
    • INFORMED CONSENT OBTAINED
  • Other: Survey Administration
    Ancillary studies
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.
  • Behavioral: Behavioral Intervention
    View cancer messaging
    Other names:
    • Behavior Conditioning Therapy
    • Behavior Modification
    • Behavior or Life Style Modifications
    • Behavior Therapy
    • Behavioral Interventions
    • Behavioral Modification
    • Behavioral Therapy
    • Behavioral Treatment
    • Behavioral Treatments
    • Behavioural
  • Other: ICF Video Version 2
    Receive a video-based informed consent form delivered by virtual human #2
    Other names:
    • Formal Consent
    • Informed Consent
    • INFORMED CONSENT OBTAINED
  • Other: Survey Administration
    Ancillary studies
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.
  • Behavioral: Behavioral Intervention
    View cancer messaging
    Other names:
    • Behavior Conditioning Therapy
    • Behavior Modification
    • Behavior or Life Style Modifications
    • Behavior Therapy
    • Behavioral Interventions
    • Behavioral Modification
    • Behavioral Therapy
    • Behavioral Treatment
    • Behavioral Treatments
    • Behavioural
  • Other: ICF Video Version 3
    Receive a video-based informed consent form delivered by virtual human #3
    Other names:
    • Formal Consent
    • Informed Consent
    • INFORMED CONSENT OBTAINED
  • Other: Survey Administration
    Ancillary studies
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.
  • Behavioral: Behavioral Intervention
    View cancer messaging
    Other names:
    • Behavior Conditioning Therapy
    • Behavior Modification
    • Behavior or Life Style Modifications
    • Behavior Therapy
    • Behavioral Interventions
    • Behavioral Modification
    • Behavioral Therapy
    • Behavioral Treatment
    • Behavioral Treatments
    • Behavioural
  • Other: ICF Video Version 4
    Receive a video-based informed consent form delivered by virtual human #4
    Other names:
    • Formal Consent
    • Informed Consent
    • INFORMED CONSENT OBTAINED
  • Other: Survey Administration
    Ancillary studies

Recruiting Locations

Mayo Clinic in Florida
Jacksonville, Florida 32224-9980
Contact:
L. ETCH Lab
904-953-5375
ETCH@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

ETCH Lab
904-953-5375
ETCH@mayo.edu