Dysautonomia International

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

Arm	Description	Assigned 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.