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Preventive Health Behavior in Women

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00723996
First Posted: July 29, 2008
Last Update Posted: December 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ruth Carlos M.D., University of Michigan
  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

Further study details as provided by Ruth Carlos M.D., 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 ]

Enrollment: 254
Study Start Date: September 2003
Study Completion Date: September 2016
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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ruth Carlos M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00723996     History of Changes
Other Study ID Numbers: HUM00048680
First Submitted: July 24, 2008
First Posted: July 29, 2008
Last Update Posted: December 16, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No