Feasibility of the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program for symptom improvement among breast cancer survivors.

OBJECTIVE: The purpose of this pilot study was to test the feasibility of delivering the mobile mindfulness-based stress reduction for breast cancer (mMBSR(BC)) program using an iPad and to evaluate its impact on symptom improvement. METHODS: A single group, pre-posttest design was implemented among female stages 0-III breast cancer survivors (BCS) who completed treatment. Data were collected at baseline and week 6 on measures of psychological and physical symptoms and quality of life. The mMBSR(BC) program is a standardized, stress-reducing intervention that combines sitting and walking meditation, body scan, and yoga and is designed to deliver weekly 2-hour sessions for 6 weeks using an iPad. RESULTS: The mean age of the 15 enrolled BCS was 57 years; one participant was non-Hispanic black, and 14 were non-Hispanic white. Of the 13 who completed the study, there were significant improvements from baseline to 6 weeks post-mMBSR(BC) in psychological and physical symptoms of depression, state anxiety, stress, fear of recurrence, sleep quality, fatigue, and quality of life (P's < .05). Effect sizes for improvements of multiple symptoms ranged from medium to large. CONCLUSIONS: These results provide preliminary support that the mMBSR(BC) program may be feasible and acceptable, showing a clinical impact on decreasing psychological and physical symptoms. This mobile-based program offers a delivery of a standardized MBSR(BC) intervention to BCS that is convenient for their own schedule while decreasing symptom burden in the survivorship phase after treatment for breast cancer.

The effects of mindfulness-based stress reduction on objective and subjective sleep parameters in women with breast cancer: a randomized controlled trial.

OBJECTIVE: The purpose of this study was to investigate the effects of mindfulness-based stress reduction for breast cancer survivors (MBSR(BC)) on multiple measures of objective and subjective sleep parameters among breast cancer survivors (BCS). METHODS: Data were collected using a two-armed randomized controlled design among BCS enrolled in either a 6-week MBSR(BC) program or a usual care (UC) group with a 12-week follow-up. The present analysis is a subset of the larger parent trial (ClinicalTrials.gov Identifier: NCT01177124). Seventy-nine BCS participants (mean age 57 years), stages 0-III, were randomly assigned to either the formal (in-class) 6-week MBSR(BC) program or UC. Subjective sleep parameters (SSP) (i.e., sleep diaries and the Pittsburgh Sleep Quality Index (PSQI)) and objective sleep parameters (OSP) (i.e., actigraphy) were measured at baseline, 6 weeks, and 12 weeks after completing the MBSR(BC) or UC program. RESULTS: Results showed indications of a positive effect of MBSR(BC) on OSP at 12 weeks on sleep efficiency (78.2% MBSR(BC) group versus 74.6% UC group, p = 0.04), percent of sleep time (81.0% MBSR(BC) group versus 77.4% UC group, p = 0.02), and less number waking bouts (93.5 in MBSR(BC) group versus 118.6 in the UC group, p < 0.01). Small nonsignificant improvements were found in SSP in the MBSR(BC) group from baseline to 6 weeks (PSQI total score, p = 0.09). No significant relationship was observed between minutes of MBSR(BC) practice and SSP or OSP. CONCLUSIONS: These data suggest that MBSR(BC) may be an efficacious treatment to improve objective and subjective sleep parameters in BCS.

Translational genomic research: the role of genetic polymorphisms in MBSR program among breast cancer survivors (MBSR[BC]).

Genetic variations of breast cancer survivors (BCS) may contribute to level of residual symptoms, such as depression, stress, fatigue, and cognitive impairment. The objective of this study was to investigate whether particular single-nucleotide polymorphisms (SNPs) moderated symptom improvement resulting from the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR[BC]) program. An overarching goal of personalized medicine is to identify individuals as risk for disease and tailor interventions based on genetic profiles of patients with diseases including cancer. BCS were recruited from Moffitt Cancer Center and University of South Florida's Breast Health Program and were randomized to either the 6-week MBSR(BC) program (n = 92) or Usual Care (n = 93). Measures of symptoms, demographic, and clinical history data were attained at baseline, 6 weeks, and 12 weeks. A total of 10 SNPs from eight genes known to be related to these symptoms were studied using genomic DNA extracted from blood. Our results were examined for effect sizes, consistency, and statistical significance (p < .05). Three SNPs (rs4680 in COMT, rs6314 in HTR2A, and rs429358 in APOE) emerged as having the strongest (though relatively weak) and most consistent effects in moderating the impact of the MBSR program on symptom outcomes. Although effects were generally weak, with only one effect withstanding multiple comparisons correction for statistical significance, this translational behavioral research may help start the identification of genetic profiles that moderate the impact of MBSR(BC). The ultimate goal of this study is the development of personalized treatment programs tailored to the genetic profile of each patient.

A Randomized Controlled Trial of the Effects of Mindfulness-Based Stress Reduction (MBSR[BC]) on Levels of Inflammatory Biomarkers Among Recovering Breast Cancer Survivors.

PURPOSE: The purpose of this substudy of a large randomized controlled trial was to evaluate the efficacy of the Mindfulness-Based Stress Reduction (Breast Cancer) (MBSR[BC]) program compared to usual care (UC) in normalizing blood levels of pro-inflammatory cytokines among breast cancer survivors (BCS). METHOD: A total of 322 BCS were randomized to either a 6-week MBSR(BC) program or a UC. At baseline and 6 and 12 weeks, 10 ml of venous blood and demographic and clinical data were collected and/or updated. Plasma cytokines (interleukin [IL]-1ß, IL-6, IL-10, tumor necrosis factor [TNF] α, transforming growth factor [TGF] ß1, soluble tumor necrosis factor receptor [sTNFR] 1) were assayed. Linear mixed models were used to assess cytokine levels across three time points (baseline and 6 and 12 weeks) by group (MBSR[BC] vs. UC). RESULTS: Of the six measured cytokines, three were nondetectable at rates greater than 50% (IL-10, IL-1ß, TGF-ß1) and, because of overall low prevalence, were not analyzed further. For the remaining cytokines (TNFα, IL-6, sTNFR1), results showed that TNFα and IL-6 increased during the follow-up period (between 6 and 12 weeks) rather than during the MBSR(BC) training period (between baseline and 6 weeks), while sTNFR1 levels did not change significantly across the 12-week period. CONCLUSIONS: Study results suggest that MBSR(BC) affects cytokine levels in BCS, mainly with increases in TNFα and IL-6. The data further suggest that B-cell modulation may be a part of immune recovery during breast cancer management and that increases in TNFα and IL-6 may be markers for MBSR(BC)-related recovery.

Mindfulness-Based Stress Reduction in Post-treatment Breast Cancer Patients: Immediate and Sustained Effects Across Multiple Symptom Clusters.

CONTEXT: Breast cancer survivors (BCS) face adverse physical and psychological symptoms, often co-occurring. Biologic and psychological factors may link symptoms within clusters, distinguishable by prevalence and/or severity. Few studies have examined the effects of behavioral interventions or treatment of symptom clusters. OBJECTIVES: The aim of this study was to identify symptom clusters among post-treatment BCS and determine symptom cluster improvement following the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR(BC)) program. METHODS: Three hundred twenty-two Stage 0-III post-treatment BCS were randomly assigned to either a six-week MBSR(BC) program or usual care. Psychological (depression, anxiety, stress, and fear of recurrence), physical (fatigue, pain, sleep, and drowsiness), and cognitive symptoms and quality of life were assessed at baseline, six, and 12 weeks, along with demographic and clinical history data at baseline. A three-step analytic process included the error-accounting models of factor analysis and structural equation modeling. RESULTS: Four symptom clusters emerged at baseline: pain, psychological, fatigue, and cognitive. From baseline to six weeks, the model demonstrated evidence of MBSR(BC) effectiveness in both the psychological (anxiety, depression, perceived stress and QOL, emotional well-being) (P = 0.007) and fatigue (fatigue, sleep, and drowsiness) (P < 0.001) clusters. Results between six and 12 weeks showed sustained effects, but further improvement was not observed. CONCLUSION: Our results provide clinical effectiveness evidence that MBSR(BC) works to improve symptom clusters, particularly for psychological and fatigue symptom clusters, with the greatest improvement occurring during the six-week program with sustained effects for several weeks after MBSR(BC) training. TRIAL REGISTRATION: Name and URL of Registry: ClinicalTrials.gov. Registration number: NCT01177124.

Moderating Effects of Genetic Polymorphisms on Improvements in Cognitive Impairment in Breast Cancer Survivors Participating in a 6-Week Mindfulness-Based Stress Reduction Program.

Breast cancer (BC) survivors often report cognitive impairment, which may be influenced by single-nucleotide polymorphisms (SNPs). The purpose of this study was to test whether particular SNPs were associated with changes in cognitive function in BC survivors and whether these polymorphisms moderated cognitive improvement resulting from the Mindfulness-Based Stress Reduction for Breast Cancer (MBSR[BC]) program. BC survivors recruited from Moffitt Cancer Center and the University of South Florida's Breast Health Program, who had completed adjuvant radiation and/or chemotherapy treatment, were randomized to either the 6-week MBSR(BC) program (n = 37) or usual care (UC; n = 35) group. Measures of cognitive function and demographic and clinical history data were attained at baseline and at 6 and 12 weeks. A total of 10 SNPs from eight genes known to be related to cognitive function were analyzed using blood samples. Results showed that SNPs in four genes (ankyrin repeat and kinase domain containing 1 [ANKK1], apolipoprotein E [APOE], methylenetetrahydrofolate reductase [MTHFR], and solute carrier family 6 member 4 [SLC6A4]) were associated with cognitive impairment. Further, rs1800497 in ANKK1 was significantly associated with improvements in cognitive impairment in response to MBSR(BC). These results may help to identify individuals who would be better served by MBSR(BC) or other interventions.