Health SMART (Stress Management and Relaxation Training)
| Status: | Archived |
|---|---|
| Conditions: | Breast Cancer, Cancer, Psychiatric |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2009 |
| End Date: | June 2011 |
Phase II Study of Stress Management and Vaccine Response Among Women at Risk for Breast Cancer
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.
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.
We found this trial at
1
site
1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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