Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials

16. august 2016 opdateret af: AIDS Malignancy Consortium

Improving Participation in AMC Clinical Trials (IMPACTS)

This pilot research trial studies factors affecting patient participation in Acquired Immune Deficiency Syndrome (AIDS) Malignancy Clinical Trials Consortium clinical trials. Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

PRIMARY OBJECTIVES:

I. To identify participant-level factors affecting recruitment of potentially eligible participants in AIDS Malignancy Clinical Trials Consortium (AMC) studies at core and affiliated sites.

SECONDARY OBJECTIVES:

I. To describe the socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites.

II. To characterize socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial.

III. To identify the perceived barriers associated with clinical trial participation among those who did not consent to participate in an AMC clinical trial.

IV. To better understand how potential study volunteers learn about AMC clinical trials and by what means are they referred to a particular study.

OUTLINE:

Participants complete the Improving Participation in AMC Clinical Trials (IMPACTS) survey comprising questions about socio-demographic information and clinical trial participation.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

82

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90024
        • UCLA Clinical AIDS Research and Education (CARE) Center
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Stroger Hospital of Cook County
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112
        • Interim LSU Public Hospital
      • New Orleans, Louisiana, Forenede Stater, 70119
        • HIV Out-patient Clinic
      • New Orleans, Louisiana, Forenede Stater, 70119
        • NO AIDS Clinic
    • New York
      • Bronx, New York, Forenede Stater, 10467
        • Montefiore Medical Center
      • Bronx, New York, Forenede Stater, 10461
        • Albert Einstein Cancer Center at Albert Einstein College of Medicine
      • Bronx, New York, Forenede Stater, 10461
        • Montefiore-Einstein Cancer Center
      • New York, New York, Forenede Stater, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, Forenede Stater, 10010
        • Laser Surgery Care
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • University of Pittsburgh Medical Center
    • Washington
      • Seattle, Washington, Forenede Stater, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, Forenede Stater, 98101
        • Virginia Mason Medical Center
      • Seattle, Washington, Forenede Stater, 98104
        • Harborview Madison Clinic

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

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

HIV-infected persons with a diagnosis of anal dysplasia or cancer who are offered informed consent on an AMC interventional clinical trial.

Beskrivelse

Inclusion Criteria:

  • HIV-infected participants
  • Cancer or anal dysplasia diagnosis
  • Offered informed consent on an AMC interventional clinical trial
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Inability to provide informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Observational (questionnaire administration)
Participants complete the IMPACTS survey comprising questions about socio-demographic information and clinical trial participation.
Andet: spørgeskemaadministration
Hjælpestudier

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant level factors affecting recruitment of potentially eligible participants in AMC intervention studies
Tidsramme: Up to 2 weeks
The proportion of individuals who are screened and agree to enroll in a clinical trial will be estimated with the binomial proportion and its 95% confidence interval.
Up to 2 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites
Tidsramme: Up to 2 weeks
Chi-square tests will be used to compare the characteristics of those who enrolled in a clinical trial with those who did not with respect to sociodemographic characteristics, sexual orientation, and disease-type and design type.
Up to 2 weeks
Socio-demographic characteristics with motivation and decision making among those who consented to participate in an AMC trial
Tidsramme: Up to 2 weeks
Chi-square tests will be used to compare the characteristics of those who enrolled in a clinical trial with those who did not with respect to sociodemographic characteristics, sexual orientation, and disease-type and design type.
Up to 2 weeks
Perceived barriers associated with clinical trial participation among those who did not consent to participate in an AMC clinical trial
Tidsramme: Up to 2 weeks
For each study participant who did not enroll in a trial, the number of barriers in each category (views and attitudes, views of other people around them, financial burden and travel) will be computed. Summary statistics (mean, standard deviation [SD], median and interquartile range) will be used to estimate number of barriers in each category. Analyses of variance will be used to assess the associations of sociodemographic characteristics, sexual orientation, disease-type and design-type with the number of barriers in each category.
Up to 2 weeks
Means by which volunteers are referred to a particular study
Tidsramme: Up to 2 weeks
For study participants who enrolled in a clinical trial, the binomial proportion will be used to estimate the proportion who answered affirmatively to each of the six statements related to decision-making about clinical trials, and the individual reasons for participating in clinical trials. For each study participant who enrolled in a trial, the number of reasons cited for participation will be computed. Summary statistics mean, SD, median and interquartile range) will be used to estimate number of reasons cited for enrollment.
Up to 2 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

AIDS Malignancy Consortium

Samarbejdspartnere

National Cancer Institute (NCI)
University of Arkansas
The Emmes Company, LLC

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

1. september 2013

Primær færdiggørelse (Faktiske)

1. september 2015

Studieafslutning (Faktiske)

1. september 2015

Datoer for studieregistrering

Først indsendt

17. september 2013

Først indsendt, der opfyldte QC-kriterier

17. september 2013

Først opslået (Skøn)

19. september 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. august 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. august 2016

Sidst verificeret

1. august 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AMC-S006 (Anden identifikator: CTEP)
  • U01CA121947 (U.S. NIH-bevilling/kontrakt)
  • NCI-2013-01152 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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 .

Kliniske forsøg med HIV-infektion

Kliniske forsøg med spørgeskemaadministration

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Sweden

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner