Screening for Familial Colorectal Cancer (CRC) Patients

June 12, 2020 updated by: M.D. Anderson Cancer Center

Screening and Risk Communication for First Degree Relatives of Colorectal Cancer Patients

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

269

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
        • University of Texas 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

No older than 60 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

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
Questionnaire
Patients with Colorectal Cancer and their First Degree Relatives (FDRs).
Questionnaire regarding awareness of screening tests and attitudes toward colorectal cancer screening, taking 30-45 minutes to complete.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Psychosocial + External factors influencing CRC patients' communication with FDRs about CRC risk & screening information
Time Frame: 2 Years
2 Years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Susan Peterson, MPH,PHD, M.D. 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 (Actual)

January 29, 2008

Primary Completion (Actual)

June 12, 2020

Study Completion (Actual)

June 12, 2020

Study Registration Dates

First Submitted

March 3, 2008

First Submitted That Met QC Criteria

March 7, 2008

First Posted (Estimate)

March 10, 2008

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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