Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response
Condition: Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

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.
    

Intervention name(s): Cognitive Behavioral Stress Management (CBSM) group intervention
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: immune response to vaccines; stress management; breast cancer