Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response

Completed · Phase 1

Conditions studied: Psychological Stress

In brief

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 distress among women at elevated risk for breast cancer. Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and secondary antibody response to vaccines compared to women in the comparison group. Hypothesis 2: Women who participate in a 10-week CBSM group intervention will report lower levels of distress immediately after and 6 months after the intervention compared to women in the comparison group.

Key facts

Study ID

NCT00121160

Run by

Fred Hutchinson Cancer Center

People needed

126

Starts

2005-09-01

Expected to finish

2010-07-01

Last updated by the study team

2012-03-27

Who can join

Age: 18 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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