Community Enhanced Virtual Informed Consent (CEVIC)
3. september 2026 oppdatert av: Mayo Clinic
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.
Studieoversikt
Status
Rekruttering
Studietype
Intervensjonell
Registrering (Antatt)
600
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: ETCH Lab
- Telefonnummer: 904-953-5375
- E-post: ETCH@mayo.edu
Studiesteder
-
-
Florida
-
Jacksonville, Florida, Forente stater, 32224-9980
- Rekruttering
- Mayo Clinic in Florida
-
Hovedetterforsker:
- Janice L. Krieger, PhD
-
Ta kontakt med:
- L. ETCH Lab
- Telefonnummer: 904-953-5375
- E-post: ETCH@mayo.edu
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hjelpestudier
Receive a text-based informed consent form
Andre navn:
Participants will view informed consent messaging presented in different formats
Andre navn:
|
|
Eksperimentell: 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.
|
Hjelpestudier
Receive an adapted text-based informed consent form
Andre navn:
Participants will view informed consent messaging presented in different formats
Andre navn:
|
|
Eksperimentell: 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.
|
Hjelpestudier
Receive a video-based informed consent form delivered by virtual human #1
Andre navn:
Participants will view informed consent messaging presented in different formats
Andre navn:
|
|
Eksperimentell: 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.
|
Hjelpestudier
Receive a video-based informed consent form delivered by virtual human #2
Andre navn:
Participants will view informed consent messaging presented in different formats
Andre navn:
|
|
Eksperimentell: 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.
|
Hjelpestudier
Receive a video-based informed consent form delivered by virtual human #3
Andre navn:
Participants will view informed consent messaging presented in different formats
Andre navn:
|
|
Eksperimentell: 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.
|
Hjelpestudier
Receive a video-based informed consent form delivered by virtual human #4
Andre navn:
Participants will view informed consent messaging presented in different formats
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Self-efficacy (Aim 1)
Tidsramme: 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.
|
Baseline (immediately following intervention)
|
|
Trustworthiness (Aim 2)
Tidsramme: 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.
|
Baseline (immediately following intervention)
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Janice L. Krieger, PhD, Mayo Clinic
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. juli 2026
Primær fullføring (Antatt)
20. juli 2027
Studiet fullført (Antatt)
20. juli 2029
Datoer for studieregistrering
Først innsendt
1. september 2026
Først innsendt som oppfylte QC-kriteriene
1. september 2026
Først lagt ut (Faktiske)
4. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 26-000655
- NCI-2026-05713 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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