Trial Information

Phase II Study of Stress Management and Vaccine Response Among Women at Risk for Breast Cancer

Cancer vaccines are emerging as important tools for cancer treatment and prevention.
Unfortunately, the cohorts that ultimately will benefit most from the vaccines, those at
elevated risk for cancer, are likely to be stressed. Chronic stress can impair immune
function, including immune response to vaccines. An inadequate response to vaccines can
weaken their protective effect. Women at elevated risk for breast cancer can experience
significant levels of distress and have associated 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; however, the findings
to date are mixed. The proposed investigation will conduct an exploratory randomized
clinical trial to collect preliminary data on the efficacy of a cognitive behavioral stress
management (CBSM) group intervention among women who are at elevated risk for breast cancer
because of family history and who are reporting elevated levels of distress. Study outcomes
will include antibody and cellular immune response to hepatitis A vaccine and self-reported
distress.