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


Phase 2
18 Years
60 Years
Not Enrolling
Female
Breast Cancer

Thank you

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.


Inclusion Criteria:



- 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.

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

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Linear mixed models regression with an exchangeable covariance structure will be used to determine the average change in IgM, IgG and proliferative response to HA vaccine antibody response to HA vaccine following the intervention, as a function of time.

Outcome Time Frame:

From post-intervention to 1-month post-intervention (primary antibody response) and from 6-months post-intervention to 7-months post-intervention (secondary antibody response)

Safety Issue:

No

Principal Investigator

Bonnie A. McGregor, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Institutional Review Board

Study ID:

IRB-6940

NCT ID:

NCT01048528

Start Date:

July 2009

Completion Date:

February 2012

Related Keywords:

  • Breast Cancer
  • immune response to vaccines
  • stress management
  • perceived risk for breast cancer
  • Breast Neoplasms

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109