NCT00965965

Brief Summary

The purpose of this study is to determine whether a newly developed patient education document concerning colorectal cancer screening will be better understood and have greater effects on patient knowledge of and motivation for screening than a standard educational document.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Shorter than P25 for not_applicable

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

August 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

August 20, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

April 27, 2012

Status Verified

April 1, 2012

Enrollment Period

8 months

First QC Date

August 20, 2009

Last Update Submit

April 26, 2012

Conditions

Colorectal Neoplasms

Keywords

health behaviorrandomized controlled trialsself-efficacypatient educationcomprehensionmass screeningprevention and control

Outcome Measures

Primary Outcomes (1)

  • Comprehension of randomly assigned educational document

    Immediately after receiving randomly assigned study intervention (that same day)

Secondary Outcomes (4)

  • Colorectal cancer screening knowledge

    Immediately after receiving randomly assigned study intervention (that same day)

  • Self-efficacy for undergoing colorectal cancer screening

    Immediately after receiving randomly assigned study intervention (that same day)

  • Perceived barriers to undergoing colorectal cancer screening

    Immediately after receiving randomly assigned study intervention (that same day)

  • Readiness to undergo colorectal cancer screening

    Immediately after receiving randomly assigned study intervention (that same day)

Study Arms (2)

Experimental patient education document

EXPERIMENTAL
Behavioral: New colorectal cancer screening patient education document

Traditional patient education document

ACTIVE COMPARATOR
Behavioral: Traditional colorectal cancer screening education document

Interventions

New colorectal cancer screening patient education documentBEHAVIORAL

The newly developed educational document was created accounting for health behavioral models (such as the Expanded Health Behavior Model, Social Cognitive Theory, and the Transtheoretical Model) and related research studies indicating the factors that most strongly and positively influence patients' cognitions regarding colorectal cancer screening and are, in turn, predictive of actual colorectal cancer screening behavior.

Experimental patient education document
Traditional colorectal cancer screening education documentBEHAVIORAL

The traditional educational document is a slightly edited version of materials freely available on the National Cancer Institute (NCI) web site, used in this study with the permission of the NCI.

Traditional patient education document

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receive primary care at one of the participating outpatient offices
  • Age 50-75
  • Able to read and speak English
  • Adequate vision, hearing, and hand function to read printed documents, communicate with research staff, answer questionnaires, and otherwise participate
  • Not up to date for colorectal cancer screening (defined as fecal occult blood test within 1 year, flexible sigmoidoscopy within 5 years, or colonoscopy within 10 years)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsHealth Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tonantzin Rodriguez, MPH

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 26, 2009

Study Start

August 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 27, 2012

Record last verified: 2012-04

Locations

US(1)