NCT00723996

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2008

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 16, 2016

Status Verified

December 1, 2016

Enrollment Period

13 years

First QC Date

July 24, 2008

Last Update Submit

December 15, 2016

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (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

Study Arms (3)

Group 1

Women receiving a CRC-related questionnaire and a CRC educational video.

Behavioral: Behavioral Study in Women

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

Interventions

Behavioral Study in WomenBEHAVIORAL

A Randomized study to assess the knowledge of womens health related issues

Group 1Group 3

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • CRC screening current (FOBT within preceding 12 months, FS within 5 years, or colonoscopy within 10 years).
  • Family history of CRC in a first-degree relative.
  • Personal history of colonic adenomatous polyps, CRC or inflammatory bowel disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Ruth Carlos, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 24, 2008

First Posted

July 29, 2008

Study Start

September 1, 2003

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

December 16, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)