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

2016年8月16日 更新者：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.

研究概览

地位

完全的

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (实际的)

82

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 观测模型：队列
  • 时间观点：预期

队列和干预

团体/队列
干预/治疗
Observational (questionnaire administration)
Participants complete the IMPACTS survey comprising questions about socio-demographic information and clinical trial participation.
其他：问卷管理
辅助研究

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Participant level factors affecting recruitment of potentially eligible participants in AMC intervention studies
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Socio-demographic characteristics for participation and non-participation in AMC clinical trials among all approached volunteers across AMC sites
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

AIDS Malignancy Consortium

合作者

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

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2013年9月1日

初级完成 (实际的)

2015年9月1日

研究完成 (实际的)

2015年9月1日

研究注册日期

首次提交

2013年9月17日

首先提交符合 QC 标准的

2013年9月17日

首次发布 (估计)

2013年9月19日

研究记录更新

最后更新发布 (估计)

2016年8月18日

上次提交的符合 QC 标准的更新

2016年8月16日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • AMC-S006 (其他标识符：CTEP)
  • U01CA121947 (美国 NIH 拨款/合同)
  • NCI-2013-01152 (注册表标识符：CTRP (Clinical Trial Reporting Program))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

爱滋病毒感染的临床试验

问卷管理的临床试验

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Philippines

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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