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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

July 13, 2005
March 26, 2012
September 2005
June 2010   (final data collection date for primary outcome 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 [ Time Frame: length of protocol ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT00121160 on ClinicalTrials.gov Archive Site
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 ]
Multiple regression analyses 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
Not Provided
Not Provided
 
Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response
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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Psychological Stress
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
July 2010
June 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00121160
IRB-6003, NCI-K01-CA107085-01
Yes
Bonnie A. McGregor, PhD / Assistant Member, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Bonnie A. McGregor, PhD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP