Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response

March 26, 2012 updated by: Fred Hutchinson Cancer Center

Can Stress Management Improve Vaccine Immune Response

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: length of protocol
length of protocol

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: length of protocol
length of protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Bonnie A. McGregor, PhD, Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

July 13, 2005

First Submitted That Met QC Criteria

July 19, 2005

First Posted (Estimate)

July 21, 2005

Study Record Updates

Last Update Posted (Estimate)

March 27, 2012

Last Update Submitted That Met QC Criteria

March 26, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-6003
  • NCI-K01-CA107085-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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