Virtual Informed Consent for Cancer Research
(CEVIC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how different methods of explaining cancer research, particularly through virtual human communicators, influence people's decisions to join these studies. Participants will review various formats of informed consent, including text and video, and evaluate the reliability of cancer study recruitment messages. It suits individuals fluent in English, residing in the United States, and identifying as either White or Black. As an unphased trial, it provides a unique opportunity to enhance the communication and understanding of cancer research.
What prior data suggests that this virtual informed consent approach is safe?
Research has shown that virtual health assistants for behavior support are generally well-received. Studies have found that these virtual tools effectively engage patients and provide ongoing access to cancer-related information. These methods are safe and often enhance patient understanding compared to just reading or listening to information. Additionally, patients report satisfaction with text-based communication during cancer care.
Studies have not reported major negative effects from using virtual or visual tools for cancer education. In fact, these methods help patients become more informed and confident about their health choices. Overall, evidence suggests that these behavioral tools are safe for use.12345Why are researchers excited about this trial?
Researchers are excited about the Virtual Informed Consent for Cancer Research because it aims to revolutionize how patients engage in cancer studies. Unlike traditional paper-based consent forms, this trial explores innovative methods like text-based and video-based informed consent, delivered by virtual human educators. These methods could enhance patient understanding and trust by providing clear, relatable information through virtual interactive experiences. By evaluating which approach patients find most credible, researchers hope to improve patient recruitment and participation in cancer research, ultimately leading to more effective studies and treatments.
What evidence suggests that this trial's treatments could be effective?
Research has shown that certain strategies can improve health for cancer patients. For instance, one study found that 58.9% of people who received helpful text messages completed their cancer screening within 21 days, compared to 49.2% of those who received a phone call. Another review found that virtual helpers, like chatbots, are easy to use, well-received, and effective in providing health support. This trial will explore various approaches to informed consent, including text and video versions delivered by virtual human educators. These findings suggest that virtual tools and targeted messages can increase participation and potentially improve cancer care outcomes.678910
Who Is on the Research Team?
Janice L. Krieger, PhD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for adults who are considering participating in cancer research and are willing to review different types of informed consent materials. There are no specific inclusion or exclusion criteria listed.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive various forms of informed consent and complete an educational cancer messaging intervention
Follow-up
Participants are monitored for self-efficacy and trustworthiness immediately following the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Behavioral Intervention
Trial Overview
The study is testing how people respond to various ways of presenting informed consent, including written text and videos with virtual human communicators, as well as surveys about their perceptions.
How Is the Trial Designed?
6
Treatment groups
Experimental Treatment
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.
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.
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Population-Based Cancer Prevention Education Intervention ...
A type-2 hybrid effectiveness-implementation study was conducted in a sample of the Spanish general population to assess adoption, fidelity, ...
Text Messaging in Cancer-Supportive Care: A Systematic ...
Overall, patients were satisfied with using text-based communication in their cancer care. Results were inconsistent within other outcome categories;
Behaviorally Informed Text Messaging to Promote Colon ...
58.9% of participants in the text message group completed screening within 21 days compared with 49.2% in the telephone call group,
An App-Based Behavioral Support Intervention Promoting ...
This study aims to investigate the efficacy of an app-based brisk walking intervention with behavioral support to increase PA in people ...
The Effectiveness and Feasibility of Conversational Agents ...
This systematic review is the first comprehensive analysis to suggest that CAs are feasible, acceptable, usable, and effective interventions ...
Virtual Health Assistants in Preventive Cancer Care ... - PMC
VHAs have the potential to promote cancer equity through facilitating patient engagement, providing round-the-clock access to information, and ...
Effectiveness of Visual-Based Interventions on ...
Visual-based interventions improved knowledge and comprehension compared to non-visual communication such as audio or basic text.
The effect of Fogg model-based virtual education on health ...
This study aims to determine the effect of Fogg model-based virtual education on cervical cancer health literacy and stages of behavior change ...
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honcology.com
honcology.com/blog/empowerment-through-education-digital-tools-that-foster-patient-centered-communicationEmpowerment Through Education: Digital Tools that Foster ...
This highlights the specialized role of digital empowerment in cancer care in addressing psychological and behavioral aspects of the cancer ...
Virtual Testis Cancer Lay Support and Survivorship Aim 2
This study examines how virtual support can enhance well-being and survivorship in men with testicular cancer.
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