- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01946217
Factors Affecting Patient Participation in AIDS Malignancy Clinical Trials Consortium Clinical Trials
Improving Participation in AMC Clinical Trials (IMPACTS)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
California
-
Los Angeles, California, Förenta staterna, 90024
- UCLA Clinical AIDS Research and Education (CARE) Center
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60612
- Stroger Hospital of Cook County
-
-
Louisiana
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New Orleans, Louisiana, Förenta staterna, 70112
- Interim LSU Public Hospital
-
New Orleans, Louisiana, Förenta staterna, 70119
- HIV Out-patient Clinic
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New Orleans, Louisiana, Förenta staterna, 70119
- NO AIDS Clinic
-
-
New York
-
Bronx, New York, Förenta staterna, 10467
- Montefiore Medical Center
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Bronx, New York, Förenta staterna, 10461
- Albert Einstein Cancer Center at Albert Einstein College of Medicine
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Bronx, New York, Förenta staterna, 10461
- Montefiore-Einstein Cancer Center
-
New York, New York, Förenta staterna, 10065
- Memorial Sloan-Kettering Cancer Center
-
New York, New York, Förenta staterna, 10010
- Laser Surgery Care
-
-
Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- University of Pittsburgh Medical Center
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98109
- Seattle Cancer Care Alliance
-
Seattle, Washington, Förenta staterna, 98101
- Virginia Mason Medical Center
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Seattle, Washington, Förenta staterna, 98104
- Harborview Madison Clinic
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Observational (questionnaire administration)
Participants complete the IMPACTS survey comprising questions about socio-demographic information and clinical trial participation.
|
Sidostudier
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Participant level factors affecting recruitment of potentially eligible participants in AMC intervention studies
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AMC-S006 (Annan identifierare: CTEP)
- U01CA121947 (U.S.S. NIH-anslag/kontrakt)
- NCI-2013-01152 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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