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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00838318
First received: February 5, 2009
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Colorectal Cancer
Behavioral: Interview

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Colorectal Cancer (CRC) Screening in First-Degree Relatives (FDRs) of Hispanic CRC Patients

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To study how these families communicate with each other and health care providers about colorectal cancer risk and screening. [ Time Frame: 5 Years ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: February 2004
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Arm 1 Hispanic CRC Patients Behavioral: Interview
Audiotaped Phone Interview/Survey, 30 - 45 minutes.
Arm 2 FDRs of Hispancic CRC Patients
First-Degree Relatives (FDRs) of Hispanic CRC Patients
Behavioral: Interview
Audiotaped Phone Interview/Survey, 30 - 45 minutes.
Arm 3 Key Informants
Key informants from Houston Hispanic Health Coalition.
Behavioral: Interview
Audiotaped Phone Interview/Survey, 30 - 45 minutes.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00838318

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Susan Peterson, PhD, MPH UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00838318     History of Changes
Other Study ID Numbers: 2004-0039
Study First Received: February 5, 2009
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Colorectal CancerScreening
CRC
Hispanic
CRC Patients
First-Degree Relatives
FDRs
Interviews
Colorectal cancer screening
CRCS
Key Informants

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 30, 2014