Mindfulness-Based Stress Reduction (MBSR) Symptom Cluster Trial for Breast Cancer Survivors

Breast cancer survivors are living longer and may be living with many symptoms incurred from the disease and its treatment. Survivors from 1 to 2 years off treatment report continued fatigue, depression, pain and sleep disturbances (Kenefick 2006; Byar et al. 2006). Patients often present with several concurrent symptoms (Dodd et al. 2001; Esper and Heidrich 2005). It is believed that symptoms tend to cluster together (two or more concurrent symptoms related to one another and independent of other symptoms) and may have natural associations, similar shared pathways and underlying mechanisms (Barsevick 2007). Currently, little is known about how symptoms cluster in breast cancer survivors after treatment, underlying mechanisms, and if interventions can influence multiple symptoms simultaneously (Lee et al. 2004; Cleeland et al. 2003). Very few studies have tested interventions during post-treatment survivorship (Cimprich et al. 2005; Mishel et al. 2005; Stanton et al. 2005; Scheier et al. 2005). Mindfulness-Based Stress Reduction (MBSR), a standardized form of meditation and yoga, has been shown to be effective in reducing anxiety, depression and stress in patients with chronic pain (Kabat-Zinn et al. 1992; Miller et al. 1995; Teasdale et al. 2000; Kabat-Zinn et al. 1985). Preliminary results from 2 pilot studies conducted by our research team provide support that MBSR for breast cancer survivors may be effective in markedly reducing symptoms, increasing quality of life, and decreasing fears of recurrence (Lengacher et al. 2009; Lengacher et al. 2006). This proposed study builds on our preliminary data of the MBSR Breast Cancer Program (BC) to reduce stress, biological markers of the stress response (pro-inflammatory cytokines) and improve physical, and psychological symptoms and quality of life in breast cancer survivors.

We aim to determine: (i) the extent to which the MBSR(BC) program is efficacious in improving outcomes; (ii) whether positive effects from MBSR(BC) are mediated through increased mindfulness and reduced fear of recurrence; and (iii) if a subgroup of patients can be determined to derive the most benefit from MBSR(BC). Formal specific aims are as follows:

Aim (1). Evaluate the efficacy of the MBSR(BC) program in improving psychological and physical symptoms, quality of life and measures of immune function and a stress hormone (cortisol). We hypothesize that compared to the usual care regimen, patients randomly assigned to the MBSR(BC) program will experience greater improvements at 6 weeks and sustained improvements at 12 weeks in the following:

1. Individual psychological symptoms, including depression anxiety, and perceived stress;
2. Individual physical symptoms, including pain, fatigue and sleep dysfunction;
3. Quality of life;
4. Biological stress markers (pro-inflammatory immune cytokines, cellular adhesion molecules, lymphocyte subsets) and a stress-related hormone (cortisol).

Aim (2). Test whether positive effects achieved from the MBSR(BC) program (defined in 1a-1d) are mediated through changes in mindfulness and fear of recurrence of breast cancer. We hypothesize that: