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Preventive Health Behavior in Women
This study is currently recruiting participants.
Verified by University of Michigan, February 2009
First Received: July 24, 2008   Last Updated: February 17, 2009   History of Changes
Sponsored by: University of Michigan
Information provided by: University of Michigan
ClinicalTrials.gov Identifier: NCT00723996
  Purpose

The overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography.


Condition Intervention
Colon Cancer
Behavioral: Behavioral Study in Women

MedlinePlus related topics: Cancer Healthy Living
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Preventive Health Behavior in Women

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • The primary outcome will be determined through review of medical records or a telephone follow-up 6 months after enrollment [ Time Frame: At 6 month intervals ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 240
Study Start Date: September 2003
Groups/Cohorts Assigned Interventions
Group 1
Women receiving a CRC-related questionnaire and a CRC educational video.
Behavioral: Behavioral Study in Women
A Randomized study to assess the knowledge of womens health related issues
Group 2
Women who receive only a CRC-related questionnaire.
Group 3
Women who receive neither questionnaire nor educational video.
Behavioral: Behavioral Study in Women
A Randomized study to assess the knowledge of womens health related issues

Detailed Description:

The overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography and to develop an innovative approach for reducing barriers colorectal cancer screening in women, using screening mammography, an existing non-colon cancer related screening test that has widespread public acceptance, as a "teachable moment." Although screening for colorectal cancer (CRC) has been shown to decrease the incidence of CRC and CRC associated mortality, adherence to screening guidelines from the American Cancer Society and the American Gastroenterological Association remains poor.1-5 Barriers to adherence are not fully defined, but may include poor understanding of the relative benefits and risks of CRC screening, absence of physician recommendation, lack of insurance coverage for screening procedures, and poor patient acceptance of screening procedures. A potential challenge in increasing patient knowledge may be the milieu in which the educational intervention is administered.

This study will be the first prospective study to evaluate the effectiveness of an educational intervention designed to increase CRC screening administered at a cancer screening visit unrelated to CRC.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Women who are scheduled for a screening mammogram at a University Medical Center who are between 50 and 75 years old will recruited.

Criteria

Inclusion Criteria:

  1. Women between the ages of 50 and 75 years old.
  2. Scheduled for a screening mammogram.

Exclusion Criteria:

  1. CRC screening current (FOBT within preceding 12 months, FS within 5 years, or colonoscopy within 10 years).
  2. Family history of CRC in a first-degree relative.
  3. Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00723996

Contacts
Contact: Ruth Carlos, MD 734-936-8872 rcarlos@umich.edu

Locations
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Ruth Carlos, MD     734-936-8872     rcarlos@umich.edu    
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Ruth Carlos, MD University of Michigan
  More Information

No publications provided

Responsible Party: University Of Michigan Health System ( Ruth Carlos MD. )
Study ID Numbers: 2003-0725
Study First Received: July 24, 2008
Last Updated: February 17, 2009
ClinicalTrials.gov Identifier: NCT00723996     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Colonic Neoplasms
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
Colonic Neoplasms
Intestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009