Screening for Familial Colorectal Cancer (CRC) Patients

• ClinicalTrials.gov Identifier: NCT00632515
• Recruitment Status: Active, not recruiting
• First Posted: March 10, 2008
• Last Update Posted: May 24, 2019
• Sponsor: M.D. Anderson Cancer Center
• Information provided by (Responsible Party): M.D. Anderson Cancer Center

Study Description

Brief Summary:

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 or disease	Intervention/treatment
Colorectal Cancer	Behavioral: Questionnaire

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 325 participants
• Observational Model: Family-Based
• Time Perspective: Cross-Sectional
• Official Title: Screening and Risk Communication for First Degree Relatives of Colorectal Cancer Patients
• Actual Study Start Date: January 29, 2008
• Estimated Primary Completion Date: January 2020
• Estimated Study Completion Date: January 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Psychosocial + External factors influencing CRC patients' communication with FDRs about CRC risk & screening information [ Time Frame: 2 Years ]

Eligibility Criteria

• Ages Eligible for Study: up to 60 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Texas

University of Texas MD Anderson Cancer Center

Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

• Principal Investigator: Susan Peterson, MPH,PHD; M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website 

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT00632515 History of Changes
• Other Study ID Numbers: 2004-0316
• First Posted: March 10, 2008
• Last Update Posted: May 24, 2019
• Last Verified: May 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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; Colonic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases