Preventive Health Behavior in Women

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ruth Carlos M.D., University of Michigan
ClinicalTrials.gov Identifier:
NCT00723996
First received: July 24, 2008
Last updated: January 15, 2013
Last verified: January 2013
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Preventive Health Behavior in Women

Resource links provided by NLM:


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 ]

Enrollment: 254
Study Start Date: September 2003
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
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

Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Ruth Carlos, MD University of Michigan
  More Information

No publications provided

Responsible Party: Ruth Carlos M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00723996     History of Changes
Other Study ID Numbers: HUM00048680
Study First Received: July 24, 2008
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on April 20, 2014