Preventive Health Behavior in Women

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT00723996
Collaborator
(none)
254
1
156
1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Behavioral Study in Women

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 Design

Study Type:
Observational
Actual Enrollment :
254 participants
Time Perspective:
Prospective
Official Title:
Preventive Health Behavior in Women
Study Start Date :
Sep 1, 2003
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. The primary outcome will be determined through review of medical records or a telephone follow-up 6 months after enrollment [At 6 month intervals]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ruth Carlos M.D., Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier:
NCT00723996
Other Study ID Numbers:
  • HUM00048680
First Posted:
Jul 29, 2008
Last Update Posted:
Dec 16, 2016
Last Verified:
Dec 1, 2016
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 16, 2016