Mindfulness and its efficacy for psychological and biological responses in women with breast cancer.
ABSTRACT: Many breast cancer survivors have to deal with a variety of psychological and physiological sequelae including impaired immune responses. The primary purpose of this randomized controlled trial was to determine the efficacy of a mindfulness-based stress reduction (MBSR) intervention for mood disorders in women with breast cancer. Secondary outcomes were symptom experience, health status, coping capacity, mindfulness, posttraumatic growth, and immune status. This RTC assigned 166 women with breast cancer to one of three groups: MBSR (8 weekly group sessions of MBSR), active controls (self-instructing MBSR) and non-MBSR. The primary outcome measure was the Hospital Anxiety and Depression Scale. Secondary outcome measures were: Memorial Symptom Assessment Scale, SF-36, Sense of Coherence, Five Facets of Mindfulness Questionnaire, and Posttraumatic Growth Index. Blood samples were analyzed using flow cytometry for NK-cell activity (FANKIA) and lymphocyte phenotyping; concentrations of cytokines were determined in sera using commercial high sensitivity IL-6 and IL-8 ELISA (enzyme-linked immunosorbent assay) kits. Results provide evidence for beneficial effects of MBSR on psychological and biological responses. Women in the MBSR group experienced significant improvements in depression scores, with a mean pre-MBSR HAD-score of 4.3 and post-MBSR score of 3.3 (P = 0.001), and compared to non-MBSR (P = 0.015). Significant improvements on scores for distress, symptom burden, and mental health were also observed. Furthermore, MBSR facilitated coping capacity as well as mindfulness and posttraumatic growth. Significant benefits in immune response within the MBSR group and between groups were observed. MBSR have potential for alleviating depression, symptom experience, and for enhancing coping capacity, mindfulness and posttraumatic growth, which may improve breast cancer survivorship. MBSR also led to beneficial effect on immune function; the clinical implications of this finding merit further research.
Project description:The stress of a breast cancer diagnosis and its treatment can produce a variety of psychosocial sequelae including impaired immune responses. Mindfulness Based Stress Reduction (MBSR) is a structured complementary program that incorporates meditation, yoga and mind-body exercises. Despite promising empirical evidence for the efficacy of MBSR, there is a need for randomized controlled trials (RCT). There is also a need for RCTs investigating the efficacy of psychosocial interventions on mood disorder and immune response in women with breast cancer. Therefore, the overall aim is to determine the efficacy of a Mindfulness Based Stress Reduction (MBSR) intervention on well-being and immune response in women with breast cancer.In this RCT, patients diagnosed with breast cancer, will consecutively be recruited to participate. Participants will be randomized into one of three groups: MBSR Intervention I (weekly group sessions + self-instructing program), MBSR Intervention II (self-instructing program), and Controls (non-MBSR). Data will be collected before start of intervention, and 3, 6, and 12 months and thereafter yearly up to 5 years. This study may contribute to evidence-based knowledge concerning the efficacy of MBSR to support patient empowerment to regain health in breast cancer disease.The present study may contribute to evidence-based knowledge concerning the efficacy of mindfulness training to support patient empowerment to regain health in a breast cancer disease. If MBSR is effective for symptom relief and quality of life, the method will have significant clinical relevance that may generate standard of care for patients with breast cancer.ClinicalTrials.gov: NCT01591915.
Project description:<h4>Context</h4>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.<h4>Objectives</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.<h4>Trial registration</h4>Name and URL of Registry: ClinicalTrials.gov. Registration number: NCT01177124.
Project description:PURPOSE:Cancer-related fatigue (CRF) is a disruptive symptom for many survivors. Despite promising evidence for efficacy of mindfulness-based stress reduction (MBSR) in reducing CRF, no trials comparing it to an active comparator for fatigued survivors have been published. The purpose of this trial was to compare MBSR to psychoeducation for CRF and associated symptoms. METHODS:Breast (n = 60) and colorectal (n = 11) cancer survivors (stage 0-III) with clinically significant CRF after completing chemotherapy and/or radiation therapy an average of 28 months prior to enrollment were randomized to MBSR or psychoeducation/support groups (PES). MBSR focused on mindfulness training; PES focused on CRF self-management. Outcomes included CRF interference (primary), CRF severity and global improvement, vitality, depression, anxiety, sleep disturbance, and pain. Outcomes were assessed at baseline (T1), post-intervention (T2), and 6-month follow-up (T3) using intent-to-treat analysis. RESULTS:Between-group differences in CRF interference were not significant at any time point; however, there was a trend favoring MBSR (d = -0.46, p = 0.073) at T2. MBSR participants reported significantly greater improvement in vitality (d = 0.53, p = 0.003) and were more likely to report CRF as moderately to completely improved compared to the PES group (?2 (1) = 4.1765, p = 0.041) at T2. MBSR participants also reported significantly greater reductions in pain at T2 (d = 0.53, p = 0.014). In addition, both MBSR and PES produced moderate-to-large and significant within-group improvements in all fatigue outcomes, depression, anxiety, and sleep at T2 and T3 compared to T1. CONCLUSION:MBSR and PES appear efficacious for CRF and related symptoms. Larger trials including a usual care arm are warranted. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT01724333.
Project description:The aim of this study was determine the effectiveness of a mindfulness-based stress-reduction (MBSR) program on quality of life (QOL) and psychosocial outcomes in women with early-stage breast cancer, using a three-arm randomized controlled clinical trial (RCT). This RCT consisting of 172 women, aged 20-65 with stage I or II breast cancer consisted of the 8-week MBSR, which was compared to a nutrition education program (NEP) and usual supportive care (UC). Follow-up was performed at three post-intervention points: 4 months, 1, and 2 years. Standardized, validated self-administered questionnaires were adopted to assess psychosocial variables. Statistical analysis included descriptive and regression analyses incorporating both intention-to-treat and post hoc multivariable approaches of the 163 women with complete data at baseline, those who were randomized to MBSR experienced a significant improvement in the primary measures of QOL and coping outcomes compared to the NEP, UC, or both, including the spirituality subscale of the FACT-B as well as dealing with illness scale increases in active behavioral coping and active cognitive coping. Secondary outcome improvements resulting in significant between-group contrasts favoring the MBSR group at 4 months included meaningfulness, depression, paranoid ideation, hostility, anxiety, unhappiness, and emotional control. Results tended to decline at 12 months and even more at 24 months, though at all times, they were as robust in women with lower expectation of effect as in those with higher expectation. The MBSR intervention appears to benefit psychosocial adjustment in cancer patients, over and above the effects of usual care or a credible control condition. The universality of effects across levels of expectation indicates a potential to utilize this stress reduction approach as complementary therapy in oncologic practice.
Project description:Solid organ transplant recipients must take immune suppressive medications that have side effects, cause complications, and lead to distressing symptoms that reduce health-related quality of life (QOL). Mindfulness meditation has been shown to reduce these symptoms in other patient populations, and it is unlikely to interfere with the immune suppressive medication regimen.This article describes the design and rationale of a clinical trial to determine whether training in mindfulness meditation can reduce depression, anxiety and insomnia after transplantation, and summarizes baseline characteristics of the participants.Transplant recipients were randomized in equal numbers to one of three arms: a Mindfulness-based Stress Reduction (MBSR) program consisting of 8 weeks of group instruction, home practice and telephone monitoring; a time and attention control Health Education program; or a waitlist arm. After serving 6 months as waitlist controls, these participants were re-randomized to MBSR or Health Education. Evaluations were obtained at baseline (prior to the active interventions), 8 weeks, 6 months, and 1 year (after randomization to MBSR or Health Education only). The primary analysis will compare composite symptom scores between MBSR and Health Education, initially or after serving in the waitlist. Subsequent analyses will compare these two groups on depression, anxiety, and insomnia symptom scales and secondary outcomes of health-related QOL, actigraphy, and health care utilization. A separate analysis, using only data collected before re-randomization, will compare short-term outcomes between the waitlist and active treatment arms.One hundred fifty recipients were randomized and 72% of waitlist participants (31/43) were recycled to an active intervention after 6 months. Patient characteristics were balanced across trial arms after initial and secondary randomizations.Transplant recipients are a very select population. Their adherence to the intervention and willingness to serve as waitlist controls prior to re-randomization may be atypical. Participants were not blinded to treatment and primary outcomes are self-reports.The innovative design used in the trial enabled the waitlist group to directly contribute to the number in the primary analysis of active arms, and to also serve as an internal validation test. The trial may be a useful model for trials involving very small target populations.
Project description: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.
Project description:Factors such as psychological well-being, sleep quality, and athletic coping skills can influence athletic performance. Mindfulness-based interventions, including mindfulness-based stress reduction (MBSR), have been shown to benefit these factors, suggesting they may, at least indirectly, benefit athletic performance. Moreover, while mindfulness training has been linked to better accuracy in some high-precision sports, whether it can improve non-precision elements of athletic performance is unclear. The objective of this study was to investigate the influence of MBSR on psychological well-being, sleep, athletic coping skills, and rowing performance in collegiate rowers in a controlled experimental design. Members of a Division I NCAA Women's Rowing team completed either an 8-week MBSR course along with their regular athletic training program (Intervention group) or the athletic training program alone (Control group). Measurements of interest were taken at baseline and again either during or shortly following the intervention. In contrast to the Control group, the Intervention group showed improvements in psychological well-being, subjective and objective sleep quality, athletic coping skills, and rowing performance as measured by a 6,000-m ergometer test. Improvements in athletic coping skills, psychological well-being, and subjective sleep quality were all correlated with increases in mindfulness in the Intervention group. These results suggest that mindfulness training may benefit non-precision aspects of athletic performance. Incorporating mindfulness training into athletic training programs may benefit quality of life and performance in student athletes.
Project description:Psychological and behavioural interventions may be effective in reducing menopause-related symptoms. This randomized controlled trial aimed to evaluate the effectiveness of Mindfulness-based Stress Reduction (MBSR) in reducing menopause-related symptoms by comparing with an active control group, the menopause education control (MEC). Symptomatic peri-menopausal and post-menopausal women with mild to moderate symptoms were recruited. The primary outcome was overall menopausal symptoms measured by modified Greene Climacteric Scale (GCS). Secondary outcomes include subscales of the GCS perceived stress, mindfulness and health related Quality of Life. All outcome measures were collected at baseline, 2 months (immediately post intervention), 5 and 8 months (3 and 6 months post intervention respectively). Both MBSR (n?=?98) and MEC (n?=?99) groups reported a reduction in total GCS score at 8 months. Between group analysis show significant symptom score reduction in MBSR group on Anxiety and Depression subscales of GCS. No differences were found between groups on other GCS subscales and majority of the secondary outcome measures. The findings show that menopausal symptoms in both MBSR and MEC significantly reduced over the study period. MBSR show a greater reduction of psychological symptoms of depression and anxiety above active controls but do not reduce other somatic, urogenital and vasomotor symptoms.
Project description:Patients who have received solid organ transplants continue to experience a myriad of complex symptoms related to their underlying disease and to chronic immunosuppression that reduce the quality of life. Beneficial nonpharmacologic therapies to address these symptoms have not been established in the transplant population.Assess the efficacy of mindfulness-based stress reduction (MBSR) in reducing symptoms of anxiety, depression, and poor sleep in transplant patients.Controlled trial with a two-staged randomization. Recipients of kidney, kidney/pancreas, liver, heart, or lung transplants were randomized to MBSR (n=72) or health education (n=66) initially or after serving in a waitlist. Mean age was 54 years (range 21-75); 55% were men, and 91% were white.MBSR, a mindfulness meditation training program consisting of eight weekly 2.5-hour classes; health education, a peer-led active control.Anxiety (State-Trait Anxiety Inventory), depression (Center for Epidemiologic Studies Depression Scale), and sleep quality (Pittsburgh Sleep Quality Index) scales assessed by self-report at baseline, 8 weeks, 6 months, and 1 year.Benefits of MBSR were above and beyond those afforded by the active control. MBSR reduced anxiety and sleep symptoms (P < .02), with medium treatment effects (.51 and .56) at 1 year compared to health education in intention-to-treat analyses. Within the MBSR group, anxiety, depression, and sleep symptoms decreased and quality-of-life measures improved by 8 weeks (P < .01, all), and benefits were retained at 1 year (P < .05, all). Initial symptom reductions in the health education group were smaller and not sustained. Comparisons to the waitlist confirmed the impact of MBSR on both symptoms and quality of life, whereas health education improvements were limited to quality-of-life ratings.MBSR reduced distressing symptoms of anxiety, depression, and poor sleep and improved quality of life. Benefits were sustained over 1 year. A health education program provided fewer benefits, and effects were not as durable. MBSR is a relatively inexpensive, safe, and effective community-based intervention.
Project description:OBJECTIVES:This study compared the impact of two different 8-week mindfulness based courses (.b Foundations and Mindfulness-Based Stress Reduction (MBSR)), delivered to school teachers, on quantitative (stress, anxiety and depression) and qualitative (experience, acceptability and implementation) outcomes. DESIGN:A mixed-methods design was employed. Matched-paired t-tests were used to examine change from baseline, with imputation conducted to account for those lost to follow-up. Qualitative methods involved 1:1 semistructured interviews (n=10). Thematic analysis was used to explore differences in experience between courses. SETTING:Courses took place in UK primary schools or nearby leisure centres, 1:1 interviews took place via telephone. PARTICIPANTS:44/69 teachers from schools in the UK were recruited from their attendance at mindfulness courses (.b and MBSR). INTERVENTIONS:Participants attended either an MBSR (experiential style learning, 2 hours per week) or .b Foundations (more classroom focused learning, 1.5 hours per week) 8-week mindfulness course. OUTCOME MEASURES:Stress (Perceived Stress Scale), anxiety and depression (Hospital Anxiety and Depression Scale) were evaluated in both groups at baseline (n=44), end of intervention (n=32) and 3-month follow-up (n=19). RESULTS:Both courses were associated with significant reductions in stress (.b 6.38; 95% CI 1.74 to 11.02; MBSR 9.69; 95% CI 4.9 to 14.5) and anxiety (.b 3.36; 95% CI 1.69 to 5.0; MBSR 4.06; 95% CI 2.6 to 5.5). MBSR was associated with improved depression outcomes (4.3; 95% CI 2.5 to 6.11). No differences were found in terms of experience and acceptability. Four main themes were identified including preconceptions, factors influencing delivery, perceived impact and training desires/practical application. CONCLUSION:.b Foundations appears as beneficial as MBSR in anxiety and stress reduction but MBSR may be more appropriate for depression. Consideration over implementation factors may largely improve the acceptability of mindfulness courses for teachers. Further research with larger samples is needed.