Traditional Print Communication Methods, Simple Electronic Communication Methods, or Usual Care in Increasing How Often Older Women Undergo Colorectal Cancer Screening
NCT ID: NCT00459030
Last Updated: 2013-08-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
904 participants
INTERVENTIONAL
2005-10-31
2012-12-31
Brief Summary
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PURPOSE: This randomized clinical trial is studying traditional print communication methods to see how well they work compared with simple electronic communication methods or usual care in increasing how often older women undergo colorectal cancer screening.
Detailed Description
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* Compare traditional print versus simple electronic communication versus usual care, in terms of increasing colorectal cancer (CRC) screening rates, in average-risk women attending a routine OB/Gyn visit.
* Explore the moderating role of attentional style and background variables on the impact of the interventions in these participants.
* Determine the mediating effect of potential cognitive-affective factors related to CRC screening in these participants.
* Investigate the comparative cost-effectiveness of these interventions to improve CRC screening adherence.
OUTLINE: This is a randomized study. Participants are randomized to 1 of 3 screening arms.
* Arm I: Participants are contacted by simple electronic communication methods by an email message linked to a personalized website.
* Arm II: Participants are contacted by traditional print communication methods.
* Arm III: Participants are observed (usual care). Participants in arms I and II are randomized a second time to receive messages about colorectal cancer screening that are matched or mismatched to their attentional style.
PROJECTED ACCRUAL: A total of 5,000 participants will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Print Communication
Cancer screening educational information mailed to patient's home one time after signing consent.
educational intervention mailed
Electronic communication
Cancer screening educational information delivered via a password protected internet site.
educational intervention via internet
additional cancer screening information via password protected internet site
No Health Communication
No additional cancer screening education information sent to patient.
No additional educational intervention
Interventions
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educational intervention via internet
additional cancer screening information via password protected internet site
educational intervention mailed
No additional educational intervention
Eligibility Criteria
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Inclusion Criteria
* At average risk for colorectal cancer (CRC) as defined by the following criteria:
* Asymptomatic without a personal history of colorectal polyps or cancer
* No inflammatory bowel disease
* No family history of familial adenomatous polyposis or hereditary nonpolyposis CRC
* No CRC in more than one first-degree relative
* Nonadherent with standard CRC screening recommendations at the time of index OB/Gyn appointment
PATIENT CHARACTERISTICS:
* Email accessible at home and/or work
* Able to communicate with ease in English
PRIOR CONCURRENT THERAPY:
* Not specified
50 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Fox Chase Cancer Center
OTHER
Responsible Party
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Principal Investigators
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David Weinberg, MD, MSC
Role: STUDY_CHAIR
Fox Chase Cancer Center
Locations
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Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Weinberg DS, Keenan E, Ruth K, Devarajan K, Rodoletz M, Bieber EJ. A randomized comparison of print and web communication on colorectal cancer screening. JAMA Intern Med. 2013 Jan 28;173(2):122-9. doi: 10.1001/2013.jamainternmed.1017.
Other Identifiers
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CDR0000538413
Identifier Type: REGISTRY
Identifier Source: secondary_id
IRB05-016
Identifier Type: OTHER
Identifier Source: secondary_id
FCCC-05016
Identifier Type: -
Identifier Source: org_study_id