Screening for Familial Colorectal Cancer (CRC) Patients - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00632515

Purpose

Primary Objectives:

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), researchers will conduct a cross-sectional study to evaluate factors influencing CRC patients' communication about CRC risk and screening information to their FDRs.

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), researchers 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:	Family-Based, Cross-Sectional
Official Title:	Screening and Risk Communication for First Degree Relatives of Colorectal Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

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

Primary Outcome Measures:

To learn about the knowledge, beliefs, and attitudes that people have toward screening for colorectal cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To study how families communicate about colorectal cancer risk and colorectal cancer screening, with each other and with health care providers. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	325
Study Start Date:	January 2008
Estimated Primary Completion Date:	January 2010 (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.

Detailed Description:

Patient will be interviewed by a member of the study staff over the telephone regarding awareness of screening tests for colorectal cancer, and attitudes toward colorectal cancer screening.

They will also be asked about family's past use of these screening tests, and discuss about colorectal cancer risks and screening with family and health care providers. Some demographic information will be collected (such as age or marital status). The questionnaire will take between 30 and 45 minutes to complete.

Answers to the questions and personal information will be kept strictly confidential. Questionnaire answers will be identified with a code number, rather than a name, so that patient 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 at UTMDACC.

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:

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.
FDRs of CRC Patients: FDRs will be eligible if they
- are age 40 years or older;
- can read and speak English.

Exclusion Criteria:

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.
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632515

Contacts

Contact: Susan Peterson, PHD, MPH

713-792-0919

Locations

United States, Texas
U.T.M.D. 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

U.T.M.D. Anderson Cancer Center

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Susan Peterson, PHD, MPH /Assistant Professor )
Study ID Numbers:	2004-0316
Study First Received:	March 3, 2008
Last Updated:	September 9, 2009
ClinicalTrials.gov Identifier:	NCT00632515 History of Changes
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

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Familial Colorectal Cancer
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases

Gastrointestinal Neoplasms
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009