Preventive Health Behavior in Women

December 15, 2016 updated by: Ruth Carlos M.D., University of Michigan
The overall goal of the proposed research is to explore behavioral correlations between colorectal cancer screening and screening mammography.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

254

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

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System

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

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At 6 month intervals

Collaborators and Investigators

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

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Ruth Carlos, MD, University of Michigan

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

September 1, 2003

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

July 24, 2008

First Submitted That Met QC Criteria

July 24, 2008

First Posted (Estimate)

July 29, 2008

Study Record Updates

Last Update Posted (Estimate)

December 16, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00048680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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