A Large Randomized Trial: Effects of Mindfulness-Based Stress Reduction (MBSR) for Breast Cancer (BC) Survivors on Salivary Cortisol and IL-6.

Breast cancer survivors (BCS) often experience psychological and physiological symptoms after cancer treatment. Mindfulness-based stress reduction (MBSR), a complementary and alternative therapy, has reduced subjective measures of stress, anxiety, and fatigue among BCS. Little is known, however, about how MBSR affects objective markers of stress, specifically the stress hormone cortisol and the pro-inflammatory cytokine interleukin-6 (IL-6). In the present study, BCS ( N = 322) were randomly assigned to a 6-week MBSR program for BC or usual-care control. Measurements of cortisol, IL-6, symptoms, and quality of life were obtained at orientation and 6 weeks. Cortisol and IL-6 were also measured prior to and after the MBSR(BC) class Weeks 1 and 6. The mean age of participants was 56.6 years and 69.4% were White non-Hispanic. Most had Stage I (33.8%) or II (35.7%) BC, and 35.7% had received chemotherapy and radiation. Cortisol levels were reduced immediately following MBSR(BC) class compared to before the class Weeks 1 and 6 (Wilcoxon-signed rank test; p < .01, d = .52-.56). IL-6 was significantly reduced from pre- to postclass at Week 6 (Wilcoxon-signed rank test; p < .01, d = .21). No differences were observed between the MBSR(BC) and control groups from baseline to Week 6 using linear mixed models. Significant relationships with small effect sizes were observed between IL-6 and both symptoms and quality of life in both groups. Results support the use of MBSR(BC) to reduce salivary cortisol and IL-6 levels in the short term in BCS.

The Enhancing Connections Program: a six-state randomized clinical trial of a cancer parenting program.

OBJECTIVE: The purpose of this study was to test the efficacy of a cancer parenting program for child rearing mothers with breast cancer, the Enhancing Connections Program. Primary goals were to decrease maternal depressed mood and anxiety, improve parenting quality, parenting skills and confidence, and enhance the child's behavioral-emotional adjustment to maternal breast cancer. METHOD: A total of 176 mothers diagnosed within 6 months with Stage 0 to Stage III breast cancer and their 8- to 12-year-old child were recruited from medical providers in 6 states: Washington, California, Pennsylvania, Minnesota, Arizona, and Indiana. After consenting and obtaining baseline measures, study participants were randomized into experimental or control groups. Experimental mothers received 5, 1-hr educational counseling sessions at 2-week intervals; controls received a booklet and phone call on communicating and supporting their child about the mother's cancer. Outcomes were assessed at 2 and 12 months. RESULTS: Compared to controls, at 2 months experimental mothers significantly improved on depressed mood and parenting skills; experimental children improved on behavioral-emotional adjustment: total behavior problems, externalizing problems, and anxiety/depressed mood significantly declined. At 1 year, experimental children remained significantly less depressed than controls on both mother- and child-reported measures. The intervention failed to significantly affect parenting self-efficacy or maternal anxiety. CONCLUSIONS: The Enhancing Connections Program benefitted mothers and children in specific areas and warrants refinement and further testing.

Influence of mindfulness-based stress reduction (MBSR) on telomerase activity in women with breast cancer (BC).

Mindfulness-based stress reduction (MBSR) reduces symptoms of depression, anxiety, and fear of recurrence among breast cancer (BC) survivors. However, the effects of MBSR (BC) on telomere length (TL) and telomerase activity (TA), known markers of cellular aging, psychological stress, and disease risk, are not known. This randomized, wait-listed, controlled study, nested within a larger trial, investigated the effects of MBSR (BC) on TL and TA. BC patients (142) with Stages 0-III cancer who had completed adjuvant treatment with radiation and/or chemotherapy at least 2 weeks prior to enrollment and within 2 years of completion of treatment with lumpectomy and/or mastectomy were randomly assigned to either a 6-week MBSR for BC program or a usual care. Assessments of TA and TL were obtained along with psychological measurements at baseline, 6 weeks, and 12 weeks after completing the MBSR(BC) program. The mean age of 142 participants was 55.3 years; 72% were non-Hispanic White; 78% had Stage I or II cancer; and 36% received both chemotherapy and radiation. In analyses adjusted for baseline TA and psychological status, TA increased steadily over 12 weeks in the MBSR(BC) group (approximately 17%) compared to essentially no increase in the control group (approximately 3%, p < .01). In contrast, no between-group difference was observed for TL (p = .92). These results provide preliminary evidence that MBSR(BC) increases TA in peripheral blood mononuclear cells from BC patients and have implications for understanding how MBSR(BC) may extend cell longevity at the cellular level.

Lymphocyte recovery after breast cancer treatment and mindfulness-based stress reduction (MBSR) therapy.

OBJECTIVES: This randomized controlled trial was conducted to examine immune recovery following breast cancer (BC) therapy and evaluate the effect of mindfulness-based stress reduction therapy (MBSR) on immune recovery with emphasis on lymphocyte subsets, T cell activation, and production of T-helper 1 (Th1; interferon [IFN]-γ) and T-helper 2 (Th2; interleukin-4 [IL-4]) cytokines. METHOD: Participants who completed the study consisted of 82 patients diagnosed with Stage 0-III BC, who received lumpectomy and adjuvant radiation ± chemotherapy. Patients were randomized into an MBSR(BC) intervention program or a control (usual care) group. Immune cell measures were assessed at baseline and within 2 weeks after the 6-week intervention. The numbers and percentages of lymphocyte subsets, activated T cells, and Th1 and Th2 cells in peripheral blood samples were determined by immunostaining and flow cytometry. RESULTS: Immune subset recovery after cancer treatment showed positive associations with time since treatment completion. The B and natural killer (NK) cells were more susceptible than T cells in being suppressed by cancer treatment. Women who received MBSR(BC) had T cells more readily activated by the mitogen phytohemagglutinin (PHA) and an increase in the Th1/Th2 ratio. Activation was also higher for the MBSR(BC) group if <12 weeks from the end of treatment and women in MBSR(BC) <12 weeks had higher T cell count for CD4(+). CONCLUSION: MBSR(BC) promotes a more rapid recovery of functional T cells capable of being activated by a mitogen with the Th1 phenotype, whereas substantial recovery of B and NK cells after completion of cancer treatment appears to occur independent of stress-reducing interventions.

A pilot study evaluating the effect of mindfulness-based stress reduction on psychological status, physical status, salivary cortisol, and interleukin-6 among advanced-stage cancer patients and their caregivers.

PURPOSE: To investigate whether a mindfulness-based stress reduction program for cancer (MBSR-C) improved psychological and physical symptoms, quality of life (QOL), and stress markers among advanced-stage cancer patients and caregivers. DESIGN: A pilot within-subject design was used. METHOD: Patients previously diagnosed with advanced-stage breast, colon, lung, or prostate cancer and on treatment were recruited from the Moffitt Cancer Center and Research Institute. Twenty-six patient-caregiver dyads completed a modified 6-week, self-study MBSR-C program based on the Kabat-Zinn model. Psychological and physical symptoms and QOL were compared pre- and post-MBSR-C sessions. Salivary cortisol and interleukin-6 were assessed pre- and post-MBSR-C session at 1, 3, and 6 weeks. FINDINGS: Following the 6-week MBSR program, patients showed improvements in stress and anxiety (p < .05); caregivers' psychological and QOL also improved but were not statistically significant. Both patients and caregivers had decreases in cortisol at Weeks 1 and 3 (p < .05) but not at Week 6. Similar to cortisol levels at Week 6, salivary interleukin-6 levels were lower overall (before/after an MBSR-C session), compared with Week 1 for patients and caregivers. CONCLUSIONS: MBSR-C may be a beneficial intervention for reducing stress, anxiety, cortisol levels, and symptoms in advanced-stage cancer patients and may also benefit caregivers.

Mindfulness based stress reduction in post-treatment breast cancer patients: an examination of symptoms and symptom clusters.

To investigate prevalence and severity of symptoms and symptom clustering in breast cancer survivors who attended MBSR(BC). Women were randomly assigned into MBSR(BC) or Usual Care (UC). Eligible women were ≥ 21 years, had been diagnosed with breast cancer and completed treatment within 18 months of enrollment. Symptoms and interference with daily living were measured pre- and post-MBSR(BC) using the M.D. Anderson Symptom Inventory. Symptoms were reported as highly prevalent but severity was low. Fatigue was the most frequently reported and severe symptom among groups. Symptoms clustered into 3 groups and improved in both groups. At baseline, both MBSR(BC) and the control groups showed similar mean symptom severity and interference; however, after the 6-week post-intervention, the MBSR(BC) group showed statistically-significant reduction for fatigue and disturbed sleep (P < 0.01) and improved symptom interference items, compared to the control group. For the between-group comparisons, 11 of 13 symptoms and 5 of 6 interference items had lower means in the MBSR(BC) condition than the control condition. These results suggest that MBSR(BC) modestly decreases fatigue and sleep disturbances, but has a greater effect on the degree to which symptoms interfere with many facets of life. Although these results are preliminary, MBSR intervention post-treatment may effectively reduce fatigue and related interference in QOL of breast cancer survivors.

Feasibility of a mindfulness-based stress reduction program for early-stage breast cancer survivors.

PURPOSE: To assess the feasibility of whether mindfulness-based stress reduction (MBSR) has a positive effect on breast cancer survivors' psychological status, psychosocial characteristics, symptoms, and quality of life (QOL) during the critical transition period from end of treatment to resumption of daily activities. DESIGN: Single-group, quasi-experimental, pretest-posttest design. METHOD: A sample of 19 women who completed breast cancer treatment with lumpectomy, radiation, and/or chemotherapy was recruited from the Moffitt Cancer Center and Research Institute, a National Cancer Institute- designated cancer center, and the University of South Florida. The authors assessed the feasibility, compliance, and whether an 8-week MBSR program positively influenced changes in psychological status (fear of recurrence, perceived stress, anxiety, depression), psychosocial characteristics (optimism, social support, spirituality), physical symptoms, and QOL. FINDINGS: Seventeen women (89.5%) completed the study. The mean age was 57 years; the majority of participants (94%) were White. The estimated compliance rate for the program was 67%. Paired t tests indicated significant improvements fear of recurrence, perceived stress, anxiety, depression, and QOL through MBSR participation. CONCLUSIONS: Participants enrolled in the MBSR classes generally were compliant. Significant improvement in psychological status, symptoms, and QOL can be achieved with MBSR use in this population.

Weight patterns in children with higher risk ALL: A report from the Children's Oncology Group (COG) for CCG 1961.

BACKGROUND: This retrospective analysis defined and described patterns and predictors of weight change during treatment in children with acute lymphocytic leukemia (ALL) with high-risk features who received treatment on Children's Cancer Group protocol CCG 1961. PROCEDURE: Patients (1,638) were enrolled in CCG 1961 from November 1996 to May 2002. Weight was measured as BMI percent (%), specific for age and gender, and defined as 100 x ln(BMI/median BMI). RESULTS: By the end of treatment, 23% of children were obese (BMI >or=95%), compared with 14% at diagnosis. Children who received post-induction intensified therapy (arms C, D, SER with Doxorubicin or Idarubicin) had higher gastrointestinal toxicities and lower BMI% from consolidation through interim maintenance 1. BMI% then increased for all arms between delayed intensification and maintenance 1 or 2. Children who were of Black or Hispanic race, obese at diagnosis, or who had grade 3 or 4 pancreatitis/glucose toxicities during induction had higher BMI% throughout treatment. Children were more likely to be obese at the end of the study if they were aged 5-9 years at diagnosis or female gender. Cranial radiation was not a predictor of obesity. CONCLUSIONS: Successful treatment of higher risk childhood ALL was associated with obesity, independent of cranial irradiation. The beginning of maintenance therapy may be the best time to intervene with nutritional and behavioral interventions, particularly for children who are obese or aged 5-9 years at diagnosis, female, Black or Hispanic, or those with metabolic toxicities during induction.

Case-control study to evaluate predictors of lymphedema after breast cancer surgery.

PURPOSE/OBJECTIVES: To identify risk factors for lymphedema after breast cancer surgery. DESIGN: Multisite case-control study. SETTING: Lymphedema clinics in the upper midwestern region of the United States. SAMPLE: 94 patients with lymphedema and 94 controls without lymphedema, matched on type of axillary surgery and surgery date. METHODS: The Measure of Arm Symptom Survey, a patient-completed tool, assessed potential risk factors for lymphedema. Severity of lymphedema was measured by arm circumference, and disease and treatment factors were collected via chart review. MAIN RESEARCH VARIABLES: Risk factors for lymphedema after breast cancer surgery. FINDINGS: On univariate analysis, patients with lymphedema were more likely than controls to be overweight (body mass index >or= 25) (p = 0.009). They also were more likely to have had axillary radiation (p = 0.011), mastectomy (p = 0.008), chemotherapy (p = 0.033), more positive nodes (p = 0.009), fluid aspirations after surgery (p = 0.005), and active cancer status (p = 0.008). Strength training (p = 0.014) and air travel (p = 0.0005) were associated with less lymphedema occurrence. On multivariate analysis, the only factor significantly associated with lymphedema was being overweight (p = 0.022). CONCLUSIONS: Being overweight is an important modifiable risk factor for lymphedema. Axillary radiation, more extensive surgery, chemotherapy, and active cancer status also were predictive of lymphedema. IMPLICATIONS FOR NURSING: This study provides evidence that excess weight contributes to lymphedema; strength training and airline travel did not contribute to lymphedema.

Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer.

OBJECTIVES: Considerable morbidity persists among survivors of breast cancer (BC) including high levels of psychological stress, anxiety, depression, fear of recurrence, and physical symptoms including pain, fatigue, and sleep disturbances, and impaired quality of life. Effective interventions are needed during this difficult transitional period. METHODS: We conducted a randomized controlled trial of 84 female BC survivors (Stages 0-III) recruited from the H. Lee Moffitt Cancer and Research Institute. All subjects were within 18 months of treatment completion with surgery and adjuvant radiation and/or chemotherapy. Subjects were randomly assigned to a 6-week Mindfulness-Based Stress Reduction (MBSR) program designed to self-regulate arousal to stressful circumstances or symptoms (n=41) or to usual care (n=43). Outcome measures compared at 6 weeks by random assignment included validated measures of psychological status (depression, anxiety, perceived stress, fear of recurrence, optimism, social support) and psychological and physical subscales of quality of life (SF-36). RESULTS: Compared with usual care, subjects assigned to MBSR(BC) had significantly lower (two-sided p<0.05) adjusted mean levels of depression (6.3 vs 9.6), anxiety (28.3 vs 33.0), and fear of recurrence (9.3 vs 11.6) at 6 weeks, along with higher energy (53.5 vs 49.2), physical functioning (50.1 vs 47.0), and physical role functioning (49.1 vs 42.8). In stratified analyses, subjects more compliant with MBSR tended to experience greater improvements in measures of energy and physical functioning. CONCLUSIONS: Among BC survivors within 18 months of treatment completion, a 6-week MBSR(BC) program resulted in significant improvements in psychological status and quality of life compared with usual care.

Massage therapy for children with cancer.

This pilot study aimed to determine the feasibility of providing massage to children with cancer to reduce symptoms in children and anxiety in parents. Twenty-three children/parent dyads were enrolled; 17 completed all data points. Children with cancer, ages 1 to 18 years, received at least 2 identical cycles of chemotherapy, and one parent, participated in the 2-period crossover design in which 4 weekly massage sessions alternated with 4 weekly quiet-time control sessions. Changes in relaxation (heart and respiratory rates, blood pressure, and salivary cortisol level) and symptoms (pain, nausea, anxiety, and fatigue) were assessed in children; anxiety and fatigue were measured in parents. Massage was more effective than quiet time at reducing heart rate in children, anxiety in children less than age 14 years, and parent anxiety. There were no significant changes in blood pressure, cortisol, pain, nausea, or fatigue. Children reported that massage helped them feel better, lessened their anxiety and worries, and had longer lasting effects than quiet time. Massage in children with cancer is feasible and appears to decrease anxiety in parents and younger children.

Complementary and alternative medicine use in children with cancer and general and specialty pediatrics.

The objective of this survey is to determine the frequency, reasons, and factors influencing use of complementary and alternative medicine (CAM) in general and specialty pediatrics within the same geographic area. Of the 281 surveys completed, CAM use was higher in children with epilepsy (61.9%), cancer (59%), asthma (50.7%), and sickle cell disease (47.4%) than in general pediatrics (36%). Children most often used prayer (60.5%), massage (27.9%), specialty vitamins (27.2%), chiropractic care (25.9%), and dietary supplements (21.8%). Parents who used CAM for themselves (68.7%) were more likely to access CAM for their child. Most parents (62.6%) disclosed some or all of their child's use of CAM to providers. This study confirms that within the same geographic region, children with chronic and life-threatening illness use more CAM therapies than children seen in primary care clinics. Children with cancer use CAM for different reasons than children with non-life-threatening illnesses.

Advances in the use of milk thistle (Silybum marianum).

Milk thistle (Silybum marianum) is an herbal supplement used to treat liver and biliary disorders. Silymarin, a mixture of flavanoid complexes, is the active component that protects liver and kidney cells from toxic effects of drugs, including chemotherapy. Although milk thistle has not significantly altered the course of chronic liver disease, it has reduced liver enzyme levels and demonstrated anti-inflammatory and T cell-modulating effects. There is strong preclinical evidence for silymarin's hepatoprotective and anticarcinogenic effects, including inhibition of cancer cell growth in human prostate, skin, breast, and cervical cells. Milk thistle is considered safe and well-tolerated, with gastrointestinal upset, a mild laxative effect, and rare allergic reaction being the only adverse events reported when taken within the recommended dose range. More clinical trials of rigorous methodology, using standardized and well-defined products and dosages, are needed to evaluate the potential of silymarin against liver toxicity, chronic liver disease, and human cancers.

Evidence for symptom management in the child with cancer.

The use of complementary/alternative medicine (CAM) has been well documented among children with cancer. This report summarizes the research evidence on the role of CAM therapies for prevention and treatment of the most commonly reported cancer-related symptoms and late effects among children with cancer. Small clinical trials document evidence of effectiveness for select therapies, such as acupuncture or ginger for nausea and vomiting, TRAUMEEL S for mucositis, and hypnosis and imagery for pain and anxiety. Several relatively small clinical trials of varying quality have been conducted on these CAM therapies in children with cancer. Some herbs have demonstrated efficacy in adults, but few studies of herbs have been conducted in children. Larger randomized clinical trials are warranted for each of these promising therapies. Until the evidence is more conclusive, the providers' role is to assess and document the child's use of CAM, critically evaluate the evidence or lack of evidence, balance the potential risks with possible benefits, and assist the family in their choices and decisions regarding use of CAM for their child with cancer.

Complementary and alternative medicine in pediatric oncology.

Children with cancer and their families use complementary and alternative medicine (CAM) to reduce symptoms, cope with life-threatening illness, and improve overall well-being. Despite numerous published surveys on the use of CAM in pediatric oncology, few studies have tested CAM therapies for safety and efficacy. A growing body of literature in adult oncology provides evidence for the role of CAM to help manage symptoms and reduce distress. Translating this research to children requires studies with new models that address family roles and include measurement of outcomes relevant to children's developmental stages and unique responses. One of the limitations in pediatrics is the small samples available to single institutions. Conducting clinical trials through the cooperative group mechanism is one way of obtaining sufficient sample sizes to determine effectiveness and safety of CAM therapies. This article summarizes research to date and describes a beginning approach to measuring outcomes of supportive CAM therapies in children with cancer.

Future directions of CAM research in pediatric oncology.

Children with cancer are using complementary and alternative medicine (CAM) to relieve symptoms, reduce side effects of treatment, and cope with the emotional aspects of having a life-threatening illness. Parental decisions about using CAM should be based on studies of efficacy and safety. Unfortunately, little evidence of efficacy is available for the majority of CAM therapies. This article discusses the methodological challenges to conducting CAM research in children and the evidence needed to support integrative medicine in pediatric oncology.

Future direction of complementary and alternative medicine (CAM) education and research.

OBJECTIVES: To identify key educational and scientific tasks for the incorporation of complementary and alternative medical therapies (CAM) into conventional health care. DATA SOURCES: Journal articles, government and special health report, book chapters, and curriculum guidebooks. CONCLUSION: Nursing education programs are rapidly adding curricula on the practice and research of CAM therapies. The next priority is to facilitate consistency and quality of educational programs by developing standards of practice and a core curriculum. Educational standards agreed upon by the nursing profession and set at the undergraduate, graduate, and professional levels will help guide the safe and effective integration of CAM into conventional health care. IMPLICATIONS FOR NURSING PRACTICE: Setting educational standards and developing consistent curricula for CAM will help students emerge from academic programs prepared for safe and effective practice and with skills to evaluate the effectiveness and participate in the research of CAM therapies.

Complementary and alternative medicine in pediatric oncology.

OBJECTIVES: To summarize research in complementary and alternative medicine (CAM) therapies used for children with cancer and to explore issues and directions for measuring outcomes of CAM therapies in children. DATA SOURCES: Scientific and research articles, internet for active research studies. CONCLUSION: CAM is increasingly used as adjunctive cancer therapies in pediatrics. Mind-body and touch therapies have the greatest evidencefor effectiveness in reducing psychological and physical stressors. Supplements and herbal therapies receive the greatest interest, however, and more research is needed to determine efficacy in improving symptoms or outcomes in children with cancer. IMPLICATIONS FOR NURSING PRACTICE: Mind-body and touch therapies can be used by nurses to reduce symptoms and anxiety in children. Potential risks and benefits should be determined for therapies that have no evidence.