NCT01072851

Brief Summary

The objective of this study is to compare the effectiveness of multimedia and print tools designed to provide patients at safety-net clinics with comprehensible information about colorectal cancer screening and motivate them to complete screening.The print and multimedia interventions were constructed with parallel content to allow valid comparison of format-related effects on knowledge and screening rates.These easy to use tools will provide under served patients at community health centers with clear and consistent messages about colorectal Cancer(CRC) and CRC screening, delivered immediately before the patients see a doctor. Specific Aims

  1. 1.To determine if multimedia and print interventions that provide patients with information and motivational messages about CRC screening increase screening rates above usual care.
  2. 2.Determine whether showing patients a multimedia program achieves higher CRC screening rates than does a print booklet with equivalent messages.
  3. 3.Examine if the effects of these multimedia and print interventions on CRC screening rates differ with literacy level.
  4. 4.Examine if the effects of these multimedia and print interventions on CRC screening differ with race/ethnicity
  5. 5.Examine if these multimedia and print interventions have differential effects on knowledge relevant to CRC screening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
920

participants targeted

Target at P75+ for phase_3 colorectal-cancer

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

3 active sites

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, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

September 7, 2012

Status Verified

September 1, 2012

Enrollment Period

4 years

First QC Date

February 18, 2010

Last Update Submit

September 6, 2012

Conditions

Keywords

colorectal cancer screeningmultimedia educationprint educationculturally competent

Outcome Measures

Primary Outcomes (1)

  • Comparison of the acceptance of colorectal cancer screening by patients who view print or multimedia educational tools

    3 months post visit

Secondary Outcomes (2)

  • Role of race/ethnicity and literacy levels on the comparative effects if the intervention

    At scheduled appointment

  • Comparative knowledge of colorectal cancer screening by patients who view the print or multi-media educational tools.

    At the scheduled patient visit

Study Arms (3)

Multimedia educational tool

EXPERIMENTAL

Multimedia education tool - A culturally competent video explaining the importance of and the process of colorectal cancer screening

Behavioral: Multimedia Education

Print educational tool

EXPERIMENTAL

Print media - A culturally competent printed brochure explaining the importance of and the process of colorectal cancer screening

Behavioral: Print Media

No intervention

ACTIVE COMPARATOR

Usual and customary waiting room process - Usual and customary office waiting period with access to standard nationally generated colorectal cancer screening informational material in the waiting room and/or exam room.

Behavioral: Usual and customary waiting room process

Interventions

A four minute exposure to an educational video with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures.

Also known as: colon cancer, communication, patient education
Multimedia educational tool
Print MediaBEHAVIORAL

Exposure to a printed brochure with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures.

Also known as: colon cancer, communication, education
Print educational tool

No specialized educational intervention to promote colorectal cancer screening or to explain the process

Also known as: colon cancer, communitcation, education
No intervention

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age,
  • Registered for an appointment at one of the target clinics,
  • Speaks English or Spanish.

You may not qualify if:

  • Patient has had CRC screening in the past 12 months,
  • Unable to review the study materials because of language, physical condition or literacy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Midlakes Medical Building

Highland Park, Illinois, 60085, United States

Location

North Chicago Health Center

North Chicago, Illinois, 60064, United States

Location

Belvidere Medical Building

Waukegan, Illinois, 60085, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Patient Education as TopicEducational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Health EducationPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Gregory Makoul, PHD

    St. Francis Hospital & Medical Center, Hartford CT

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 22, 2010

Study Start

July 1, 2008

Primary Completion

July 1, 2012

Study Completion

September 1, 2012

Last Updated

September 7, 2012

Record last verified: 2012-09

Locations