NCT00593073

Brief Summary

Effective programs are needed that can overcome barriers to CRC screening among persons in rural communities. There is good evidence to suggest that a program employing patient activation and tailoring to address the specific concerns of individuals will be an effective model for addressing CRC screening underutilization for rural residents. In this study, we propose to test such a model among rural primary care patients, a group that has, to date, received little attention. We will also bolster how tailored messaging is traditionally conducted by using a tailored informational flyer format that uses physicians as the message source to increase message saliency. This study will help to assess how a relatively low-cost, disseminable technology can effectively circumvent the "systems problems" endemic in rural primary care. This project will lay the groundwork in practice based research network clinics for future intervention studies which operationalize office and community-based technology to help rural primary care patients make informed health decisions and engage in healthy lifestyle behaviors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
707

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Jul 2005

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

July 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed
Last Updated

September 12, 2008

Status Verified

September 1, 2008

Enrollment Period

2.4 years

First QC Date

December 31, 2007

Last Update Submit

September 10, 2008

Conditions

Outcome Measures

Primary Outcomes (1)

  • Baseline assessment while waiting to see primary care physician and 90-day follow-up telephone survey.

    Baseline, 90 Days

Secondary Outcomes (1)

  • Follow-up survey to assess participant discussion of colorectal cancer with their healthcare provider and compliance with CRC screening

    90 Days

Study Arms (2)

1

EXPERIMENTAL

Tailored Reminder Message

Behavioral: Electronic tailored messaging

2

EXPERIMENTAL

General Reminder Message

Behavioral: General Reminder Message

Interventions

Tailored CRC message based on patient screening barriers, preferences and attitudes and reminder to get screened.

1

General CRC health education message and reminder to get screened.

2

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • at average risk for colorectal cancer
  • not up to date with colorectal cancer screening

You may not qualify if:

  • Younger than 50 years of age
  • at high risk for colorectal cancer
  • up to date with colorectal cancer screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Kimberly K. Engelman, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 14, 2008

Study Start

July 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

September 12, 2008

Record last verified: 2008-09

Locations