Caring for Those Who Share: Improving the Health of Wisconsin Blood Donors

Colorectal Cancer Clinical Trial

Official title:

Caring for Those Who Share: Improving the Health of Wisconsin Blood Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772083
• Other study ID #: PRO00008944
• Status: Completed
• Phase: N/A
• First received: October 13, 2008
• Last updated: August 10, 2010
• Start date: November 2008
• Est. completion date: June 2009

Study information

• Verified date: August 2010
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Blood donors are a precious community resource. Each month at Blood Center of Wisconsin (BCW), 200 men and 600 women over age 50 are turned away ("deferred") because of anemia. In those over 50, anemia may signal serious underlying disease such as colorectal cancer (CRC). CRC is the #3 cause of cancer death in Wisconsin with more than 1,000 deaths in 2006. Yet with proper testing CRC outcomes can be improved by early diagnosis. This project will focus on a population of deferred older blood donors to develop and test educational materials that will motivate donors to seek medical attention for their anemia, so that the underlying cause is diagnosed and treated. This project has the potential to lead to better CRC outcomes in Wisconsin blood donors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult blood donors who have been "deferred" (not allowed to donate) due to low blood count, specifically all male donors found to have hematocrit < 38% and to all female donors over 50 years old found to have hematocrit < 36%

Exclusion Criteria:

• deferred donors who have previously donated more than 3 times in the past year, as their anemia is more likely due to frequent donation

• women less than 50 years old

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anemia
• Colorectal Cancer

Intervention

Behavioral:
• Educational brochure
This brochure will educate anemic blood donors regarding the possible causes of their anemia, and based on age will make recommendations for who should seek consultation with a physician.
• Standard pamphlet
The BloodCenter of Wisconsin's default action when a potential donor has been found to be anemic is to provide a standard pamphlet with very basic nutritional information.

Locations

Country	Name	City	State
United States	BloodCenter of Wisconsin	Milwaukee	Wisconsin

Sponsors (4)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Blood Center of Wisconsin, Healthier Wisconsin Partnership Program, National Anemia Action Council

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-reported seeking of medical care for diagnosis of anemia found at time of blood donation		3 months	No