Clinical Trials Education Program for Hispanic Americans
3. marts 2020 opdateret af: Georgia Robins Sadler, University of California, San Diego
Randomized Controlled Clinical Trials Education Program for Hispanic Americans
Hispanic Americans are underrepresented in cancer clinical trials.
The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test education programs designed to reduce barriers and Increase facilitators associated with cancer clinical trials participation for Hispanic Americans. Focus groups were conducted with Hispanic American men and women to obtain culturally-linked attitudes related to clinical trials participation. This information was used to create a prototypic educational program anticipated to increase participation in clinical trials. It was then vetted and honed via additional focus groups.
Simultaneously, a validation study was conducted with Hispanic Americans for a packet of psychosocial instruments that could be used for a subsequent randomized controlled trial to evaluate the impact of the clinical trials education program.
The finalized clinical trials education program was tested via a randomized controlled trial. Participants assigned to the experimental group received the clinical trials education program, while participants in the control arm were administered a comparable, but non-relevant education program. Recruitment to this study has been completed.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1034
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
California
-
La Jolla, California, Forenede Stater, 92093-0850
- UC San Diego Moores Cancer Center
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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
21 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Self-identified as Hispanic American
- At least 21 years of age
- Sufficiently literate to comprehend written and spoken testing materials in English or Spanish
- Living in southern California
- Mentally competent to complete the informed consenting process
Exclusion Criteria:
-
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cancer Clinical Trials Education Program
Cancer Clinical Trials Education Program is offered to English- and Spanish-speaking Hispanics in the experimental arm.
This program was designed to promote increased clinical trials literacy among Hispanic Americans.
Increased clinical trials knowledge and a better understanding of clinical trials is anticipated to create more positive attitudes, and perceptions about clinical trials among Hispanic Americans.
|
Hispanic Americans are underrepresented in cancer clinical trials.
The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.
|
|
Placebo komparator: Neighborhood Watch Education Program
The Neighborhood Watch Program created by the Bureau of Justice Assistance and the National Crime Prevention Council was selected for inclusion in the control arm of this study.
It provided participants with a program of equivalent length and format, as well as an equivalent focus on improving the well-being of Hispanic Americans.
It also provided an opportunity to evaluate the impact of the Neighborhood Watch Program.
|
Hispanic Americans are underrepresented in cancer clinical trials.
The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to First Follow-up
Tidsramme: Change from baseline to first follow-up (immediately after receiving intervention)
|
To assess the impact of the intervention arm on participants' knowledge, attitudes, and perceptions related to clinical trials, they were asked to complete the same surveys given at baseline during post-intervention immediately after intervention.
|
Change from baseline to first follow-up (immediately after receiving intervention)
|
|
Change in Participants' Clinical Trials-Related Knowledge, Attitudes and Beliefs From Baseline to Second Follow-up
Tidsramme: Change from baseline to second follow-up (three months after receiving intervention)
|
At the three-month follow-up, participants were mailed the final packet of survey instruments to complete and return in a stamped, self-addressed envelope.
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Change from baseline to second follow-up (three months after receiving intervention)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Willingness to Participate in Research
Tidsramme: Two weeks after receiving intervention
|
Two weeks after receiving the intervention, participants were mailed an invitation to participate in a different research study by a researcher not previously known to them, to assess whether the intervention influenced behavior related to clinical trials invitations.
|
Two weeks after receiving intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Georgia R Sadler, PhD, UC San Diego Moores Cancer Center
- Ledende efterforsker: Vanessa L Malcarne, PhD, San Diego State University
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.
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)
1. marts 2010
Primær færdiggørelse (Faktiske)
1. august 2018
Studieafslutning (Faktiske)
1. august 2018
Datoer for studieregistrering
Først indsendt
4. marts 2014
Først indsendt, der opfyldte QC-kriterier
6. marts 2014
Først opslået (Skøn)
11. marts 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. marts 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. marts 2020
Sidst verificeret
1. marts 2020
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- CCT2525
- NCI R25CA 130869 (Anden identifikator: UCSD)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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 .