Health SMART (Stress Management and Relaxation Training)

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

The study will examine the effects of a cognitive behavioral stress management (CBSM) group intervention on antibody and cellular immune function among women who are at elevated risk for breast cancer because of family history. Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and secondary antibody response to HA vaccine compared to women in the comparison group. Hypothesis 2: In response to stimulation with HA antigen, lymphocytes from women who participate in the CBSM intervention will have larger primary and secondary in-vitro proliferative response to HA antigen, and increased primary and secondary in-vitro TH1 cytokine response to HA antigen compared to lymphocytes from women in the comparison group. Hypothesis 3: Women who participate in the 10-week CBSM group intervention will report lower levels of distress immediately after the intervention compared to women in the comparison group. Changes in distress as a result of the intervention will be associated with any significant changes in immune function discovered in Aims 1 and 2.

Key facts

Study ID

NCT01048528

Run by

Fred Hutchinson Cancer Center

People needed

33

Starts

2009-07-01

Expected to finish

2012-02-01

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…

• Family history of breast cancer
• Fluent in English
• Working phone and address
• Plan to live in the area for one year
• Reporting elevated levels of distress at screening.

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
• Use of immune modulating drugs (e.g. corticosteroids, antihistamines), nicotine, or > 3 drinks/ day alcohol

Where it is running

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

Full record on ClinicalTrials.gov

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