Breast Cancer Clinical Trial
Official title:
Mindfulness Based Stress Reduction for Psycho-Immune Dysregulation
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.
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.
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