Mindfulness, Breast Cancer and Psycho-Immune Dysregulation
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the benefits of a Mindfulness Based Stress Reduction
      (MBSR) program for psycho-immune dysregulation in women newly diagnosed with breast cancer
      compared to women with breast cancer completing an attention control condition (health
      education classes). Women will be randomized to either the MBSR or health education classes.
      They will complete psychometric instruments evaluating psychological outcomes and will
      provide blood samples for immune outcomes. They will also provide saliva samples for cortisol
      diurnal rhythm determination. Measures will be done longitudinally pre and post MBSR or
      health education program. It is hypothesized that MBSR participants will exhibit improved
      psychological and immunological outcomes over time, as compared to women randomized to the
      health education classes.
    

Detailed description: 
      The Mindfulness-Based Stress Reduction (MBSR) program is designed to cultivate conscious
      awareness (i.e., mindfulness) of one's experience in a non-judgmental or accepting manner
      (Kabat-Zinn, et al., 1990). Mindfulness programs may facilitate recovery from cancer.
      However, most prior mindfulness investigations for women with breast cancer focused on cancer
      survivors, well beyond the acute period of cancer diagnosis and treatment. Moreover, few of
      these studies evaluated immune measures with relevance to cancer.

      Women diagnosed with early stage breast cancer (Stages 0, 1, 2, and 3) will be enrolled.
      Eligible women will be identified after completion of their breast surgery and when surgical
      pathology reports are available. Women will complete psychometric instruments and study
      questionnaires. They will provide blood for immune measures and saliva for cortisol diurnal
      rhythm. Measures will be done at five separate time points. These are pre-, mid-, and
      completion of either the MBSR or the attention control program, as well as at 1- and 6-months
      post-program. Demographic information and information about health behaviors will be
      collected by self-report. Wrist actigraphy for an additional assessment of sleep quality will
      be done in an exploratory manner. Hierarchical linear modeling will be used to compute
      multilevel model for change, based on full maximum likelihood estimation (Raudenbush, S. W.,
      and A. S. Bryk. 2002). Hierarchical linear modeling will be applied to examine
      intra-individual and inter-individual differences in initial status (baseline) and
      trajectories of change over time.
    

Intervention name(s): Mindfulness Based Stress Reduction; Health Education Series
Intervention type(s): Behavioral; Other
Intervention description(s): This is an active comparator condition that consists of 8 weekly classes related to health.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Breast cancer, mindfulness, immune, stress