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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00121160
First received: July 13, 2005
Last updated: March 26, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Psychological Stress
Behavioral: Cognitive Behavioral Stress Management (CBSM) group intervention
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Can Stress Management Improve Vaccine Immune Response

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: September 2005
Study Completion Date: July 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Cognitive Behavioral Stress Management (CBSM) group intervention
    Participants will meet in closed, structured groups of 4 to 6 women for ten weekly, 2-hour group sessions. The intervention employs CBSM techniques interwoven with information in a supportive group format. The information portion of the intervention focuses on learning to cope with daily stressors, and learning about optimal use of social support. Group members and group leaders are used as role models for effective coping and the use of social support. The groups also encourage emotional expression and provide an opportunity to practice techniques learned in the group and experience social support. Avoidance coping is discouraged, and acceptance and reframing are instead encouraged as coping responses. Health behavior change, framed as a coping technique, will also be discussed using motivational interviewing techniques. Each week participants also experience a different relaxation technique. The goal of the CBSM intervention is thus to reduce distress through a variety of techniques.
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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00121160

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Bonnie A. McGregor, PhD Fred Hutchinson Cancer Research Center
  More Information

Publications:

Responsible Party: Bonnie A. McGregor, PhD / Assistant Member, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00121160     History of Changes
Other Study ID Numbers: IRB-6003, NCI-K01-CA107085-01
Study First Received: July 13, 2005
Last Updated: March 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
immune response to vaccines
stress management
breast cancer

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 18, 2014