Evaluating Biobanking Educational Tools
17. september 2021 opdateret af: H. Lee Moffitt Cancer Center and Research Institute
The purpose of this study is to evaluate English and Spanish language educational materials that inform the community about a type of cancer research that involves the collection, storage, and processing of biospecimens. Part A of this study involved creating surveys about biospecimen donation and research. Now, a randomized controlled trial (RCT) will begin to evaluate education materials about biospecimen donation and research.
Phase II consists of two independent randomized controlled trials. Each trial is being conducted independently to test English and Spanish language materials (75 subjects each).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The project addresses gaps in information by developing and validating English and Spanish language instruments to measure knowledge of and attitudes towards biospecimen donation and banking, as well as intention to donate biospecimens to a biobank (Part A).
Once developed, the instruments will be used to evaluate biobanking educational priming tools by conducting two independent RCTs.
Wherein English educational materials will be tested with 75 participants recruited from an urban clinic, and Spanish educational materials will be tested with 75 participant recruited form a rural community health center network.
For each RCT following baseline assessment, participants will be randomized to either: 1) educational priming tools (DVD and booklet) developed by the Tampa Bay Community Cancer Network (TBCCN); or 2) an NCI-developed brochure entitled "Providing Your Tissue for Research: What You Need to Know."
Seven to 28 days later participants will be given a telephone follow up interview.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
339
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Florida
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Tampa, Florida, Forenede Stater, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
English Language RCT Inclusion Criteria:
- scheduled for an appointment at Lifetime Cancer Screening (LCS)
- able to read and speak English
- able to provide informed consent
Spanish Language RCT Inclusion Criteria:
- receiving care at a participating clinic from the Suncoast Community Health Centers network
- able to read and speak Spanish
- able to provide informed consent
Exclusion Criteria:
- previously diagnosed with cancer
- previously participated in a biobank
- participated in another TBCCN-related study entitled "community perceptions on biobanking"
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: TBCCN-developed educational materials
Biobanking educational DVD and booklet kit developed by the Tampa Bay Community Network (TBCCN) Center.
English kit is entitled "Biobanking Hope for a Cancer Cure", and Spanish kit is entitled "Biobanco: Una esperanza de cura para el cancer."
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Participants will be asked to view the educational materials developed by TBCCN, in either English or Spanish depending on the RCT in which they are enrolled.
These materials include a DVD and a booklet that were developed to enhance community members' understanding and awareness of biospecimen collection and biobanking from healthy individuals.
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Andet: Control Group
Biobanking educational Brochure developed by the National Cancer Institute.
English brochure is entitled "Providing your Tissue for Research: What you need to Know", Spanish brochure is entitled "Lo que usted debe saber antes de dar sus tejidos para investigación médica."
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Participants will be asked to view the English biobanking educational Brochure entitled "Providing your Tissue for Research: What you need to Know", or Spanish brochure entitled "Lo que usted debe saber antes de dar sus tejidos para investigación médica."
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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BANKS-Knowledge Scale
Tidsramme: Average of 28 days
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Administered at baseline and between 7 and 28 days after enrollment.
Description: A validated 16-item questionnaire measuring knowledge about biobanking.
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Average of 28 days
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BANKS-Attitudes Scale
Tidsramme: Average of 28 days
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Administered at baseline and between 7 and 28 days after enrollment.
Description: A validated 15-item questionnaire measuring attitudes toward biobanking.
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Average of 28 days
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BANKS-Self-Efficacy Scale
Tidsramme: Average of 28 days
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Administered at baseline and between 7 and 28 days after enrollment.
Description: A validated 12-item questionnaire measuring self-efficacy in regards to donating a biospecimen to a biobank.
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Average of 28 days
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BANKS-Intentions
Tidsramme: Average of 28 days
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Administered at baseline.
Description: A single item measuring intentions to donate a biospecimen to a biobank.
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Average of 28 days
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Decisional Self-Efficacy
Tidsramme: Average of 28 days
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Administered at follow-up (between 7 and 28 days after enrollment).
Description: A validated 11-item questionnaire measuring participant's confidence in making a decision about donating a biospecimen (O'Connor M.A. Decision Self-efficacy Scale.
1995; www.ohri.ca/decisionaid).
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Average of 28 days
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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BANKS-Trust Scale
Tidsramme: Average of 28 days
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Administered at baseline and between 7 and 28 days after enrollment.
Description: A validated 10-item questionnaire measuring trust related to organizations, facilities, and people that may be involved in research.
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Average of 28 days
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Clement Gwede, PhD, MPH, RN, H. Lee Moffitt Cancer Center and Research Institute
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
27. september 2010
Primær færdiggørelse (Faktiske)
31. august 2016
Studieafslutning (Faktiske)
17. september 2021
Datoer for studieregistrering
Først indsendt
22. august 2012
Først indsendt, der opfyldte QC-kriterier
22. august 2012
Først opslået (Skøn)
27. august 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. september 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. september 2021
Sidst verificeret
1. september 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MCC-16448
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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