Hematopoietic and Lymphatic System NeoplasmCEVICNCT07805083
Community Enhanced Virtual Informed Consent
A study testing Educational Cancer Intervention, ICF Text Version 1 and ICF Text Version 2 in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Educational Cancer Intervention, ICF Text Version 1 and ICF Text Version 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2026to 20 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
L. ETCH Lab, 904-953-5375, ETCH@mayo.edu
Janice L. Krieger, PhD
About this study
Official title: Exploring Health Communication Message Factors That Influence Cancer Research Recruitment
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.
- Being tested
- Educational Cancer Intervention, ICF Text Version 1, ICF Text Version 2, ICF Video Version 1, ICF Video Version 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Cancer InterventionBehavioural
Also called Behavioural
Participants will view informed consent messaging presented in different formats
ICF Text Version 1Other
Also called Formal Consent, Informed Consent, INFORMED CONSENT OBTAINED
Receive a text-based informed consent form
ICF Text Version 2Other
Also called Formal Consent, Informed Consent, INFORMED CONSENT OBTAINED
Receive an adapted text-based informed consent form
ICF Video Version 1Other
Also called Formal Consent, Informed Consent, INFORMED CONSENT OBTAINED
Receive a video-based informed consent form delivered by virtual human #1
ICF Video Version 2Other
Also called Formal Consent, Informed Consent, INFORMED CONSENT OBTAINED
Receive a video-based informed consent form delivered by virtual human #2
ICF Video Version 3Other
Also called Formal Consent, Informed Consent, INFORMED CONSENT OBTAINED
Receive a video-based informed consent form delivered by virtual human #3
ICF Video Version 4Other
Also called Formal Consent, Informed Consent, INFORMED CONSENT OBTAINED
Receive a video-based informed consent form delivered by virtual human #4
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I - ICF Text Version 1 | Experimental | 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. Receives: Behavioral: Educational Cancer Intervention; Other: ICF Text Version 1; Other: Survey Administration |
| Arm II - ICF Text Version 2 | Experimental | 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. Receives: Behavioral: Educational Cancer Intervention; Other: ICF Text Version 2; Other: Survey Administration |
| Arm III - ICF Video Version 1 | Experimental | 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. Receives: Behavioral: Educational Cancer Intervention; Other: ICF Video Version 1; Other: Survey Administration |
| Arm IV - ICF Video Version 2 | Experimental | 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. Receives: Behavioral: Educational Cancer Intervention; Other: ICF Video Version 2; Other: Survey Administration |
| Arm V - ICF Video Version 3 | Experimental | 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. Receives: Behavioral: Educational Cancer Intervention; Other: ICF Video Version 3; Other: Survey Administration |
| Arm VI - ICF Video Version 4 | Experimental | 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. Receives: Behavioral: Educational Cancer Intervention; Other: ICF Video Version 4; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy (Aim 1)
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.
Measured: Baseline (immediately following intervention)
Trustworthiness (Aim 2)
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.
Measured: Baseline (immediately following intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start21 Jul 2026
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Janice L. Krieger, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07805083
- Sponsor's protocol ID
- 26-000655
- Other IDs
- NCI-2026-05713
- Acronym
- CEVIC
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Health Communication Message Factors That Influence Cancer Research Recruitment
- ClinicalTrials.gov ID
- NCT07805083
- Acronym / sponsor ID
- CEVIC / 26-000655
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2029 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm I - ICF Text Version 1 | Experimental | Behavioral: 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 2 | Experimental | Behavioral: 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 1 | Experimental | Behavioral: 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 2 | Experimental | Behavioral: 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 3 | Experimental | Behavioral: 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 4 | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Cancer InterventionAlso: BehaviouralParticipants will view informed consent messaging presented in different formats | Behavioural | Arm I - ICF Text Version 1, Arm II - ICF Text Version 2, Arm III - ICF Video Version 1, Arm IV - ICF Video Version 2, Arm V - ICF Video Version 3, Arm VI - ICF Video Version 4 |
| ICF Text Version 1Also: Formal Consent, Informed Consent, INFORMED CONSENT OBTAINEDReceive a text-based informed consent form | Other | Arm I - ICF Text Version 1 |
| ICF Text Version 2Also: Formal Consent, Informed Consent, INFORMED CONSENT OBTAINEDReceive an adapted text-based informed consent form | Other | Arm II - ICF Text Version 2 |
| ICF Video Version 1Also: Formal Consent, Informed Consent, INFORMED CONSENT OBTAINEDReceive a video-based informed consent form delivered by virtual human #1 | Other | Arm III - ICF Video Version 1 |
| ICF Video Version 2Also: Formal Consent, Informed Consent, INFORMED CONSENT OBTAINEDReceive a video-based informed consent form delivered by virtual human #2 | Other | Arm IV - ICF Video Version 2 |
| ICF Video Version 3Also: Formal Consent, Informed Consent, INFORMED CONSENT OBTAINEDReceive a video-based informed consent form delivered by virtual human #3 | Other | Arm V - ICF Video Version 3 |
| ICF Video Version 4Also: Formal Consent, Informed Consent, INFORMED CONSENT OBTAINEDReceive a video-based informed consent form delivered by virtual human #4 | Other | Arm VI - ICF Video Version 4 |
| Survey AdministrationAncillary studies | Other | Arm I - ICF Text Version 1, Arm II - ICF Text Version 2, Arm III - ICF Video Version 1, Arm IV - ICF Video Version 2, Arm V - ICF Video Version 3, Arm VI - ICF Video Version 4 |
Primary outcome
Self-efficacy (Aim 1)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janice L. Krieger, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Cancer Intervention, ICF Text Version 1 and ICF Text Version 2 in people with Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ETCH Lab (904-953-5375, ETCH@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy (Aim 1) (time frame: Baseline (immediately following intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.