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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01072851
Other study ID # 0910001-E
Secondary ID
Status Completed
Phase Phase 3
First received February 18, 2010
Last updated September 6, 2012
Start date July 2008
Est. completion date September 2012

Study information

Verified date September 2012
Source Saint Francis Care
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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. 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. Determine whether showing patients a multimedia program achieves higher CRC screening rates than does a print booklet with equivalent messages.

1. Examine if the effects of these multimedia and print interventions on CRC screening rates differ with literacy level.

2. Examine if the effects of these multimedia and print interventions on CRC screening differ with race/ethnicity

3. Examine if these multimedia and print interventions have differential effects on knowledge relevant to CRC screening.


Description:

Despite the clear benefits of screening for early detection and prevention of colorectal cancer, as many as half of eligible adults remain unscreened. Poor and under served populations, particularly African American and Latino/Hispanic adults, are at greatest risk for noncompliance with recommended tests. Health education strategies developed to date have led to relatively minimal gains, resulting in little translation to routine clinical practice. This is especially true in more difficult, resource-strained practice settings, such as community health centers.

The interventions in the proposed study draw on communication science to optimize message design, use communication technology to optimize message delivery and include parallel content in both print and multimedia versions to allow comparison of format-related effects on both knowledge and screening rates.The multimedia and print tools are based on patient education programs that we developed with extensive attention to theory as well as community member input.


Recruitment information / eligibility

Status Completed
Enrollment 920
Est. completion date September 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria:

- 50-80 years of age,

- Registered for an appointment at one of the target clinics,

- Speaks English or Spanish.

Exclusion Criteria:

- Patient has had CRC screening in the past 12 months,

- Unable to review the study materials because of language, physical condition or literacy.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Multimedia Education
A four minute exposure to an educational video with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures.
Print Media
Exposure to a printed brochure with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures.
Usual and customary waiting room process
No specialized educational intervention to promote colorectal cancer screening or to explain the process

Locations

Country Name City State
United States Midlakes Medical Building Highland Park Illinois
United States North Chicago Health Center North Chicago Illinois
United States Belvidere Medical Building Waukegan Illinois

Sponsors (3)

Lead Sponsor Collaborator
Saint Francis Care American Cancer Society, Inc., Feinberg School of Medicine, Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of the acceptance of colorectal cancer screening by patients who view print or multimedia educational tools 3 months post visit No
Secondary Role of race/ethnicity and literacy levels on the comparative effects if the intervention At scheduled appointment No
Secondary Comparative knowledge of colorectal cancer screening by patients who view the print or multi-media educational tools. At the scheduled patient visit No
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