Traditional Print Communication Methods, Simple Electronic Communication Methods, or Usual Care in Increasing How Often Older Women Undergo Colorectal Cancer Screening

Study Overview
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Brief Summary
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RATIONALE: Finding out which communication method affects a participant's decision to undergo colorectal cancer screening may help increase the number of participants who undergo screening. It is not yet known which communication method is more effective in increasing how often participants undergo colorectal cancer screening. 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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OBJECTIVES: 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.

Official Title
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Two Delivery Channels to Improve CRC Screening

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: educational intervention via internet
* Other: educational intervention mailed
* Other: No additional educational intervention


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Print Communication<br>Cancer screening educational information mailed to patient's home one time after signing consent. | Other: educational intervention mailed<br> <br> |
| Experimental: Electronic communication<br>Cancer screening educational information delivered via a password protected internet site. | Other: educational intervention via internet<br>* additional cancer screening information via password protected internet site<br>|
| Active Comparator: No Health Communication<br>No additional cancer screening education information sent to patient. | Other: No additional educational intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of traditional print versus simple electronic communication versus usual care in terms of increasing colorectal cancer (CRC) screening rates |  | End of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderating role of attentional style and background variables on the impact of the interventions |  | End of Study | 
| Mediating effect of potential cognitive-affective factors related to CRC screening |  | End of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer