Screening for Familial Colorectal Cancer (CRC) Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00632515
First received: March 3, 2008
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

The goal of this psychosocial research study is to learn about the knowledge, beliefs, and attitudes that people have toward screening for colorectal cancer. Another goal is to study how families communicate about colorectal cancer risk and colorectal cancer screening, with each other and with health care providers.

Objectives:

  1. To evaluate psychosocial and external factors influencing colorectal cancer (CRC) patients' communication with their first-degree relatives (FDRs) about CRC risk and screening information.

    Using measures of knowledge, health beliefs and behavior, family closeness, openness and motivation to discuss CRC and screening, distress, provider support and background variables (sociodemographics, access to care, and medical history), we will conduct a cross-sectional study to evaluate factors influencing CRC patients' communication about CRC risk and screening information to their FDRs.

  2. To evaluate psychosocial and external factors associated with CRC screening behavior among first-degree relatives of CRC patients.

Using measures of knowledge, health beliefs and behavior, family closeness and subjective norms, distress, provider interactions, benefits/barriers, and background variables (race/ethnicity, sociodemographics, access to care, and medical history), we will conduct a cross-sectional study of FDRs of CRC patients recruited under Aim 1 to evaluate factors associated with CRC screening behavior (specifically, colonoscopy adherence).


Condition Intervention
Colorectal Cancer
Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Cross-Sectional
Official Title: Screening and Risk Communication for First Degree Relatives of Colorectal Cancer Patients

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Psychosocial + External factors influencing CRC patients' communication with FDRs about CRC risk & screening information [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 325
Study Start Date: January 2008
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Questionnaire
Patients with Colorectal Cancer and their First Degree Relatives (FDRs).
Behavioral: Questionnaire
Questionnaire regarding awareness of screening tests and attitudes toward colorectal cancer screening, taking 30-45 minutes to complete.
Other Name: Survey

Detailed Description:

You will be interviewed by a member of the study staff over the telephone. You will be asked about your awareness of screening tests for colorectal cancer, and your attitudes toward colorectal cancer screening. You also will also be asked about your family's past use of these screening tests, 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.

This is an investigational study. Up to 325 colorectal cancer patients and their close relatives may take part in the study. All will be enrolled MD Anderson.

  Eligibility

Ages Eligible for Study:   up to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients with diagnosis of Colorectal Cancer at or before age 60 years, and their First Degree Relatives (FDRs) who are age 40 years or older.

Criteria

Inclusion Criteria:

  1. Colorectal cancer (CRC) Patients: CRC patients will be eligible if they:

    • have a diagnosis of colorectal adenocarcinoma at or before age 60, and were diagnosed between 6 and 12 months prior to being contacted about this study (to allow adequate time for dissemination of CRC risk to family members, and to avoid interference with care surrounding the initial diagnosis);
    • have at least one living FDR age 40 years or older;
    • can read and speak English.
  2. FDRs of CRC Patients: FDRs will be eligible if they

    • are age 40 years or older;
    • can read and speak English.

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
    • have an ECOG PS>1.
  2. FDRs of CRC patients: FDRs 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 colon polyps or of cancer diagnosed within 5 years prior to entry into the study, with the exception of nonmelanoma skin cancer.
  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: NCT00632515

Contacts
Contact: Susan Peterson, PHD, MPH 713-792-0919

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

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00632515     History of Changes
Other Study ID Numbers: 2004-0316
Study First Received: March 3, 2008
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Colorectal Cancer
CRC
Familial CRC
Cancer Screening
Questionnaire
First Degree Relatives
FDRs
Risk Communication

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 October 19, 2014