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Colon Cancer Screening in First-Degree Relatives of Hispanic Colorectal Cancer (CRC) Patients

2012年7月26日 更新者:M.D. Anderson Cancer Center

Colorectal Cancer (CRC) Screening in First-Degree Relatives (FDRs) of Hispanic CRC Patients

Primary Objectives:

  1. To evaluate knowledge, beliefs, attitudes and values that influence perceptions and utilization of colorectal cancer screening (CRCS) among first-degree relatives of Hispanic CRC patients.
  2. To assess factors influencing Hispanic CRC patients' communication of CRC risk and screening information to their FDRs.

Secondary Objective:

1) To establish the feasibility of recruiting Hispanic CRC patients and their FDRs from the institutional patient database and/or MDACC clinics.

研究概览

地位

完全的

条件

详细说明

CRC PATIENTS AND THEIR FDRS:

You will be asked to complete a questionnaire by telephone interview. The study researcher who calls you will ask for your permission to audiotape the interview. The questionnaire asks about your awareness of screening tests for colorectal cancer, your family's past use of these screening tests, your attitudes toward colorectal cancer screening, and how you discuss colorectal cancer risk and screening with your family and health care providers. Some demographic information also will be collected (such as your age or marital status). The questionnaire will take between 30 and 45 minutes to complete.

Your answers to the questions and your personal information will be kept strictly confidential. Your questionnaire answers will be identified with a code number, rather than a name, so that you cannot be identified. Audiotaped recordings will be destroyed after all the data have been collected and studied (no longer than 5 years).

This is an investigational study. Up to 60 colorectal cancer patients and their close relatives may be enrolled in the study. All will be enrolled at M. D. Anderson.

KEY INFORMANT:

You will be asked to complete a psychosocial interview either in person or by telephone. The study staff member interviewing you will ask you for permission to audiotape the interview. You will be asked to review the interview guides for colorectal cancer patients and their first degree relatives (FDRs), and provide feedback about them. The interviewer will ask for your opinions about Hispanics' awareness and understanding of colorectal cancer screening. You will also be asked for your opinion about cultural beliefs and practices that may influence participation in colorectal cancer screening. The interview will take between 30 and 45 minutes to complete.

Your answers to the questions and your personal information will be kept strictly confidential. Your questionnaire answers will be identified with a code number, rather than a name, so that you cannot be identified. Audiotaped recordings will be destroyed after all the data have been collected and studied (no longer than 5 years).

This is an investigational study. Up to 15 key informants may be enrolled in this study. All will be enrolled at M. D. Anderson.

研究类型

观察性的

注册 (实际的)

26

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

    • Texas
      • Houston、Texas、美国、77030
        • UT MD Anderson Cancer Center

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 至 70年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Key Informants from Houston Hispanic Health Coaltion having professional expertise relevant to this study; MDACC Hispanic/Latino CRC Patients, age 18 - 60 years with first degree relatives between age 40 - 70; First-degree relatives (siblings and children) of the MDACC CRC cancer patients recruited to this study, who are aged 40 - 70 years.

描述

Inclusion Criteria:

  1. Key Informants: Persons will be identified as potentially eligible key informants if they are: 1) members of the Houston Hispanic Health Coalition, or if they are identified through the Houston Hispanic Health Coalition as having professional expertise relevant to this study. 2) Able to speak English or Spanish. 3) Able to provide informed consent.
  2. CRC Patients: Eligibility criteria include: 1) Living MDACC patients with a personal history of colorectal adenocarcinoma (diagnosed as local or regional disease), who are between the ages of 18 and 60 years, who are identified as Hispanic/Latino, and who have living first degree relatives (siblings or children) between the ages of 40 and 70. 2) Able to provide informed consent. Eligible persons may speak either English or Spanish.
  3. First-degree relatives (FDRs): Eligibility criteria include: 1) First-degree relatives (siblings and children) of the MDACC CRC cancer patients who are recruited to this study, who are 40 to 70 years of age. 2) Able to provide informed consent. Eligible persons may speak either English or Spanish.
  4. Note: As described in the above inclusion criteria, this protocol involves recruiting and interviewing of key informants, CRC patients, and eligible first-degree relatives (FDRs) of CRC patients for three phases of the study.

Exclusion Criteria:

  1. CRC Patients: CRC patients will be excluded if they have a history of a known hereditary CRC syndrome (e.g., HNPCC, familial polyposis) or inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), or were diagnosed with distant metastases.
  2. First degree relatives: FDRs of eligible CRC patients will be excluded if they have a history of a known hereditary CRC syndrome (e.g., HNPCC, familial polyposis) or inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease), or have a personal history of cancer (except non-melanoma skin cancer) or polyps.

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

队列和干预

团体/队列
干预/治疗
Arm 1 Hispanic CRC Patients
Audiotaped Phone Interview/Survey, 30 - 45 minutes.
Arm 2 FDRs of Hispancic CRC Patients
First-Degree Relatives (FDRs) of Hispanic CRC Patients
Audiotaped Phone Interview/Survey, 30 - 45 minutes.
Arm 3 Key Informants
Key informants from Houston Hispanic Health Coalition.
Audiotaped Phone Interview/Survey, 30 - 45 minutes.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
To look at the knowledge, beliefs, and attitudes toward screening for colorectal cancer among Hispanic colorectal cancer patients and their close relatives.
大体时间:5 Years
5 Years

次要结果测量

结果测量
大体时间
To study how these families communicate with each other and health care providers about colorectal cancer risk and screening.
大体时间:5 Years
5 Years

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。

调查人员

  • 首席研究员:Susan Peterson, PhD, MPH、UT MD Anderson Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2004年2月1日

初级完成 (实际的)

2010年3月1日

研究完成 (实际的)

2010年3月1日

研究注册日期

首次提交

2009年2月5日

首先提交符合 QC 标准的

2009年2月5日

首次发布 (估计)

2009年2月6日

研究记录更新

最后更新发布 (估计)

2012年7月30日

上次提交的符合 QC 标准的更新

2012年7月26日

最后验证

2012年7月1日

更多信息

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.

Interview的临床试验

3
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