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

July 26, 2012 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To look at the knowledge, beliefs, and attitudes toward screening for colorectal cancer among Hispanic colorectal cancer patients and their close relatives.
Time Frame: 5 Years
5 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
To study how these families communicate with each other and health care providers about colorectal cancer risk and screening.
Time Frame: 5 Years
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Susan Peterson, PhD, MPH, UT MD Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

February 5, 2009

First Submitted That Met QC Criteria

February 5, 2009

First Posted (Estimate)

February 6, 2009

Study Record Updates

Last Update Posted (Estimate)

July 30, 2012

Last Update Submitted That Met QC Criteria

July 26, 2012

Last Verified

July 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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