Clinical trial NCT00121160: Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response
Official title: Can Stress Management Improve Vaccine Immune Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psychological Stress
Keywords: immune response to vaccines
stress management
breast cancer
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-07-21
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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 completed.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: length of protocol
Secondary outcomes:
measure: Multiple regression analyzes will be used to test changes in cortisol and changes in perceived risk of breast cancer; coping or social support mediate the effects of the intervention on antibody response to vaccine and distress
timeFrame: length of protocol
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Bonnie A. McGregor, PhD
role: PRINCIPAL_INVESTIGATOR
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