- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07795385
Embodied Conversational Agents for CervicalCancer Screening Abnormalities (ECA-CCSA)
Embodied Conversational Agents for Cervical Cancer Screening Abnormalities
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: ECA-CCSA Research Coordinator
- Telefonnummer: 617-651-9410
- E-mail: saramyhealthnav@tuftsmedicine.org
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- age 21-65
- has an abnormal cervical cancer screening test result
- able to read in English or Spanish
Exclusion Criteria
- planning to move out of the study area during the follow up period
- pregnant
- incarcerated
- dose not have adequate vision or hearing to use the app
- diagnosed with cervical cancer
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Styring
Kun standard for pleje
|
|
|
Eksperimentel: Conversational agent only
Receives conversational agent to provide personalized education
|
People receiving the intervention will receive an animated health coach that works on a smartphone to guide them through the cervical cancer screening and care process to ensure they receive the follow up and treatment they need to prevent cancer.
|
|
Eksperimentel: conversational agent and advocacy
Receives conversational agent to provide personalized education and also guidance on talking to family and friends about cancer screening
|
People receiving the intervention will receive an animated health coach that works on a smartphone to guide them through the cervical cancer screening and care process to ensure they receive the follow up and treatment they need to prevent cancer.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The proportion of participants who receive recommended follow-up testing and treatment.
Tidsramme: 18 months
|
18 months
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Perkins, Tufts Medical Center
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 00006533
- 1R01CA296021-01A1 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
ACCESS, DISTRIBUTION, OR REUSE CONSIDERATIONS Data will be shared under a two-tier distribution system. All data that can be de-identified will be publicly shared. Data with specific confidentially risks, such as transcripts of interviews will not be shared publicly because of the difficulty masking the identity of participants. Data with increased risk of reidentification will be shared under a data-use agreement that clearly establish use rules to facilitate respondent confidentiality
WHETHER ACCESS TO SCIENTIFIC DATA WILL BE CONTROLLED
De-identified data will be freely available on the repository website. Restricted data (I.e., de-identified transcripts of interviews) will be available through a data use agreement. Data use agreements providing access to sensitive data will be managed by the repository of record.
PROTECTIONS FOR PRIVACY, RIGHTS, AND CONFIDENTIALITY OF HUMAN RESEARCH PARTICIPANTS
In order to ensure participant consent for data sharing, IRB paperwork and informed
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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