Status:
COMPLETED
Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Psychological Stress
Eligibility:
FEMALE
18-60 years
Phase:
PHASE1
Brief Summary
The proposed investigation will conduct a randomized, clinical trial to test the efficacy of a cognitive behavioral stress management (CBSM) group intervention on immune response to vaccine and distre...
Detailed Description
Chronic stress can impair immune function, including immune response to vaccines. This has important implications for cancer control and prevention because tumor vaccines are emerging as tools for can...
Eligibility Criteria
Inclusion
- Female, age 18-60 years
- Family history of breast cancer
- Fluent in English
- Working phone
- Working address
- Plan to live in the area for one year
Exclusion
- Prior cancer diagnosis (except non-melanoma skin cancer)
- Current major depressive episode
- History of Bipolar Disorder or Schizophrenia
- History of autoimmune disease
- History of Hepatitis A or HA vaccination
- Current infectious disease
- Use of immune modulating drugs
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00121160
Start Date
September 1 2005
End Date
July 1 2010
Last Update
March 27 2012
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109