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Can Stress Management Improve Vaccine Immune Response

Phase 1
18 Years
60 Years
Not Enrolling
Psychological Stress

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Trial Information

Can Stress Management Improve Vaccine Immune Response

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 cancer treatment and prevention, and the cohort that would benefit from the
vaccines is likely to be stressed. Women at elevated risk for breast cancer experience
significant levels of distress that have been associated with immune function decrements.
Interventions to treat distress-related immune decrements among these women are needed
because these women will be among the first candidates for breast cancer vaccines. In
theory, stress-management interventions should improve immune function and response to
vaccines, but the findings to date are mixed, in part because most intervention studies have
been done with medical patients who by nature have immune confounds. Thus, it is unknown how
stress management interventions affect immune function in stressed but otherwise healthy
people, such as women at elevated risk for breast cancer.

Comparison: Women will be randomly assigned to a 10-week structured, CBSM intervention or a
wait-list comparison group with delay participation in the intervention. The comparison
group will be offered the full CBSM intervention after all assessment time points have been

Inclusion Criteria:

- 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 Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Independent sample t-test will be used to compare 1) antibody change scores from before to after the first and second dose of vaccine, and 2) distress change scores from before to after the intervention

Outcome Time Frame:

length of protocol

Safety Issue:


Principal Investigator

Bonnie A. McGregor, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center


United States: Institutional Review Board

Study ID:




Start Date:

September 2005

Completion Date:

July 2010

Related Keywords:

  • Psychological Stress
  • immune response to vaccines
  • stress management
  • breast cancer
  • Stress, Psychological



Fred Hutchinson Cancer Research Center Seattle, Washington  98109