Health SMART (Stress Management and Relaxation Training)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will examine the effects of a cognitive behavioral stress management (CBSM) group
      intervention on antibody and cellular immune function among women who are at elevated risk
      for breast cancer because of family history.

      Hypothesis 1: Women who participate in the CBSM intervention will have a larger primary and
      secondary antibody response to HA vaccine compared to women in the comparison group.

      Hypothesis 2: In response to stimulation with HA antigen, lymphocytes from women who
      participate in the CBSM intervention will have larger primary and secondary in-vitro
      proliferative response to HA antigen, and increased primary and secondary in-vitro TH1
      cytokine response to HA antigen compared to lymphocytes from women in the comparison group.

      Hypothesis 3: Women who participate in the 10-week CBSM group intervention will report lower
      levels of distress immediately after the intervention compared to women in the comparison
      group. Changes in distress as a result of the intervention will be associated with any
      significant changes in immune function discovered in Aims 1 and 2.
    

Detailed description: 
      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.
    

Intervention name(s): Cognitive Behavioral Stress Management (CBSM)
Intervention type(s): Behavioral
Intervention description(s): 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. 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. Relaxation techniques include progressive muscle relaxation, guided imagery, autogenics, meditation, and deep breathing. The goal of the CBSM intervention is thus to reduce distress through a variety of techniques.
Other intervention name(s): Stress Management and Relaxation Training (SMART)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immune response to vaccines; stress management; perceived risk for breast cancer