Sex Differences in Risk of Severe Adverse Events in Patients Receiving Immunotherapy, Targeted Therapy, or Chemotherapy in Cancer Clinical Trials.

PURPOSE: Women have more adverse events (AEs) from chemotherapy than men, but few studies have investigated sex differences in immune or targeted therapies. We examined AEs by sex across different treatment domains. METHODS: We analyzed treatment-related AEs by sex in SWOG phase II and III clinical trials conducted between 1980 and 2019, excluding sex-specific cancers. AE codes and grade were categorized using the Common Terminology Criteria for Adverse Events. Symptomatic AEs were defined as those aligned with the National Cancer Institute's Patient-Reported Outcome-Common Terminology Criteria for Adverse Events; laboratory-based or observable/measurable AEs were designated as objective (hematologic v nonhematologic). Multivariable logistic regression was used, adjusting for age, race, and disease prognosis. Thirteen symptomatic and 14 objective AE categories were examined. RESULTS: In total, N = 23,296 patients (women, 8,838 [37.9%]; men, 14,458 [62.1%]) from 202 trials experiencing 274,688 AEs were analyzed; 17,417 received chemotherapy, 2,319 received immunotherapy, and 3,560 received targeted therapy. Overall, 64.6% (n = 15,051) experienced one or more severe (grade ≥ 3) AEs. Women had a 34% increased risk of severe AEs compared with men (odds ratio [OR] = 1.34; 95% CI, 1.27 to 1.42; P < .001), including a 49% increased risk among those receiving immunotherapy (OR = 1.49; 95% CI, 1.24 to 1.78; P < .001). Women experienced an increased risk of severe symptomatic AEs among all treatments, especially immunotherapy (OR = 1.66; 95% CI, 1.37 to 2.01; P < .001). Women receiving chemotherapy or immunotherapy experienced increased severe hematologic AE. No statistically significant sex differences in risk of nonhematologic AEs were found. CONCLUSION: The greater severity of both symptomatic AEs and hematologic AEs in women across multiple treatment modalities indicates that broad-based sex differences exist. This could be due to differences in AE reported, pharmacogenomics of drug metabolism/disposition, total dose received, and/or adherence to therapy. Particularly large sex differences were observed for patients receiving immunotherapy, suggesting that studying AEs from these agents is a priority.

Healthcare Provider Perspectives on Adherence to Adjuvant Endocrine Therapy after Breast Cancer.

Adherence to adjuvant endocrine therapy (AET) for breast cancer is suboptimal. The purpose of this study was to: (1) explore the experiences and perspectives of healthcare providers (HCPs) in providing care to breast cancer survivors prescribed AET, (2) identify how social and structural factors influence the provision of AET-related care, and (3) ascertain HCP recommendations for optimizing AET adherence and related care. Individual, in-depth interviews were conducted with 14 HCPs using an interpretive descriptive approach to inquiry and the theoretical lens of relational autonomy. Data was analyzed using thematic and constant comparative techniques. Healthcare providers focused on four main components of AET-related care: (1) the importance of having careful conversations about AET, (2) difficulties in navigating transitions in care, (3) symptom management as a big part of their role, and (4) dealing with AET discontinuation. Recommendations to improve AET adherence focused on developing sustainable and efficient models of delivering high-quality care to women on AET. Healthcare providers play a pivotal role educating women about AET and supporting their adherence to therapy. Sustainable healthcare system innovations and new models of care that address current system gaps are needed to enhance survivorship care, AET adherence, and ultimately, reduce cancer recurrence and mortality.

Mammographic density parameters and breast cancer tumor characteristics among postmenopausal women.

PURPOSE: Mammographic density is an important breast cancer risk factor, although it is not clear whether the association differs across breast cancer tumor subtypes. We examined the association between indicators of mammographic density and breast cancer risk by tumor subtype among postmenopausal women by investigating heterogeneity across tumor characteristics. METHODS: Mammographic density measures were determined for 477 breast cancer cases and 588 controls, all postmenopausal, in Vancouver, British Columbia, using digitized screening mammograms and Cumulus software. Mammographic dense (DA), non-dense (NDA), and percent dense (PDA) areas were treated as continuous covariates and categorized into quartiles according to the distribution in controls. For cases only, tests for heterogeneity between tumor subtypes were assessed by multinomial logistic regression. Associations between mammographic density and breast cancer risk were modeled for each subtype separately through unconditional logistic regression. RESULTS: Heterogeneity was apparent for the association of PDA with tumor size (p-heterogeneity=0.04). Risk did not differ across the other assessed tumor characteristics (p-heterogeneity values >0.05). CONCLUSION: These findings do not provide strong evidence that mammographic density parameters differentially affect specific breast cancer tumor characteristics.

Toward equitably high-quality cancer survivorship care.

Although models of cancer survivorship care are rapidly evolving, there is increasing evidence of health disparities among cancer survivors. In the current context, Canada's survivorship care systems privilege some and not others to receive high-quality care and optimize their health outcomes. The aim of this study was to improve survivorship care systems by helping clinicians and decision makers to a better understanding of how various psychosocial/political factors, survivors' health experiences and health management strategies might shape the development of and access to high-quality survivorship care for Canadians with cancer. Using a nursing epistemological approach informed by critical and intersectional perspectives, we conducted a three-phased Interpretive Description study. We engaged in critical textual analysis of documentary sources, a secondary analysis of interview transcripts from an existing database, and qualitative interviews with 34 survivors and 12 system stakeholders. On the basis of these data, we identified individual, group, and system factors that contributed to gaps between survivors' expected and actual survivorship care experiences. By understanding what shapes survivorship care systems and resources, we help illuminate and unravel the complex nature of the issue, supporting clinicians and decision makers to find multi-layered approaches for equitably high-quality survivorship care.

Understanding adjuvant endocrine therapy persistence in breast Cancer survivors.

BACKGROUND: Adjuvant endocrine therapy (AET) significantly decreases the risk of breast cancer recurrence and mortality. Notwithstanding the demonstrated efficacy of AET, 31-73% of breast cancer survivors do not persist with AET. The purpose of this study was to explore breast cancer survivors' experiences and perspectives of persisting with AET and to identify the psychosocial and healthcare system factors that influence AET persistence. METHODS: Informed by interpretive descriptive methodology and relational autonomy theory, individual interviews were conducted with 22 women diagnosed with early-stage breast cancer who had been prescribed AET. These participants also completed a demographic form and a survey that assessed their perceived risk of recurrence. Interviews were analysed using inductive thematic and constant comparative analysis to iteratively compare data and develop conceptualizations of the relationships among data. Descriptive statistics were used to summarize the quantitative data. RESULTS: The personal, social, and structural factors found to influence AET persistence included AET side effects, perception of breast cancer recurrence risk, medication and necessity beliefs, social support, the patient-provider relationship, and the continuity and frequency of follow-up care. For most women, over time, the decision-making process around AET persistence became a balancing act between quality of life and quantity of life. The interplay between the personal, social, and structural factors was complex and the weight women placed on some factors over others influenced their AET persistence or non-persistence. CONCLUSION: Expanding our understanding of the factors affecting breast cancer survivors' AET persistence from their perspective is the first step in developing efficacious, patient-centered interventions aimed at improving AET persistence. In order to improve AET persistence, enhanced symptom management is required, as well as the development of supportive care strategies that acknowledge the values and beliefs held by breast cancer survivors while reinforcing the benefits of AET, and addressing women's reasons for non-persistence. Improved continuity of health care and patient-healthcare provider communication across oncology and primary care settings is also required. The development and evaluation of supportive care strategies that address the challenges associated with AET experienced by breast cancer survivors hold the potential to increase both women's quality and quantity of life.

Literature review: dermal monitoring data for pesticide exposure assessment of farm workers.

OBJECTIVE: To conduct a literature review to determine the types of information that existing dermal pesticide monitoring data could provide for future pesticide exposure assessment in occupational epidemiology. METHODS: A systematic literature search was performed on eight online databases. Two screening phases with predetermined criteria identified the qualifying literature. Standard information and dermal pesticide monitoring data were recorded and summarized from each qualifying study to assess its usefulness for future pesticide exposure assessment. RESULTS: A total of 31 farm studies qualified for review; task information was used to standardize all farm job(s) evaluated into 5 job groups: operators, applicators, mixer-loaders, field workers, and flaggers. When attempting to compare dermal exposure levels between studies, two types of variation were identified: (1) variation in study focus and reporting and 2) variation in exposure levels. The former variation type prevented exposure level comparisons between studies. Within studies, exposure levels were compared across body parts to identify that which had the highest measured exposure and to determine if results were similar in other studies that evaluated the same farm job. Using studies that measured exposure for multiple farm jobs, within study comparisons of total body exposure were performed to evaluate work factors. CONCLUSION: Future dermal pesticide exposure monitoring studies should standardize reporting procedures, as suggested in this review, to allow for more extensive dermal data comparisons. Body parts with highest measured levels of dermal exposure were identified by farm job, along with work factors to be further investigated as potential dermal pesticide exposure determinants for farm workers.

Promoting bone health management in women diagnosed with breast cancer: a pilot randomized controlled trial.

This study investigates, in women diagnosed with breast cancer, the feasibility of evaluating the effects of educational material and its delivery method, on bone health management. The study results suggest educational material may improve rates of bone mineral density testing. INTRODUCTION: Educational materials improve bone mineral density (BMD) testing rates in high-risk patients, but the effect is unknown in women diagnosed with breast cancer. Methods of delivering educational materials may also affect testing rates. The purposes of this study were to determine the feasibility of the protocol and to pilot-test the effects of educational material and its delivery methods on BMD testing rates. METHOD: Pilot randomized controlled trial with block randomization. Fifty-four women (aged 65-75 and diagnosed with breast cancer ≥ 3 years ago (2010-2012) and not taking osteoporosis medication) were recruited from February to May 2016 and randomized to three groups: control without educational material, educational material delivered by postal mail, and educational material delivered by patient choice of postal mail, email, or text messaging. Outcome measures were primarily evaluated using self-report questionnaires. RESULTS: The participation rate, defined as the proportion of eligible participants who consented to participate, was 39.1%. Primary outcome measure was obtained for 98% of the recruited women. During the 6-month follow-up period, BMD testing rates were significantly higher in the groups receiving educational materials by mail (26%, 95%CI = 10 to 49) and by patient choice (18%, 95%CI = 5 to 41), when compared with the control group (6%, 95%CI = 0.3 to 25). Educational material was associated with a 17% higher BMD testing rate. CONCLUSIONS: The study protocol is feasible for a large-scale study. The educational material intervention is broadly accepted by the study participants with a promising positive effect on BMD testing rates.

Aromatase inhibitors are associated with a higher fracture risk than tamoxifen: a systematic review and meta-analysis.

BACKGROUND: In this paper, our aim was to systematically evaluate published evidence of bone fracture risk associated with tamoxifen and aromatase inhibitors in women aged 65 and under, and diagnosed with nonmetastatic breast cancer. METHODS: We comprehensively searched MEDLINE, EMBASE and CINAHL databases from January 1997 through May 2015, and reference lists of the selected articles to identify English-language randomized controlled trials and cohort studies of fracture risk. Two independent reviewers screened articles and assessed methodological quality using Risk of Bias assessment for randomized controlled trials and the Newcastle-Ottawa Scale for cohort studies. Fracture risk was estimated as pooled risk ratios using a random-effects model and inverse variance method. RESULTS: Of 1926 identified articles, 21 independent studies fulfilled our selection criteria. Similar fracture risk was observed in women treated and not treated with tamoxifen [pooled risk ratio (RR) 0.95; 95% confidence interval (CI) 0.84-1.07]. A 35% (95% CI 1.21-1.51) higher fracture risk was observed in the aromatase inhibitor group compared with the tamoxifen group. A 17% (95% CI 1.07-1.28) higher fracture risk was observed in the aromatase inhibitor group than the no aromatase inhibitor group. Compared with the tamoxifen group, aromatase inhibitor-associated fracture risk increased by 33% (pooled RR 1.33; 95% CI 1.21-1.47) during the tamoxifen/aromatase inhibitor treatment period, but did not increase (pooled RR 0.99; 95% CI 0.72-1.37) during the post-tamoxifen/aromatase inhibitor treatment period. CONCLUSIONS: Fracture risk is significantly higher in women treated with aromatase inhibitors, especially during the treatment period. Tamoxifen is not associated with lower fracture risk while tamoxifen could potentially preserve bone mass. Better osteoporosis management programs, especially during the treatment period, are needed for this group of women.

Mammographic non-dense area and breast cancer risk in postmenopausal women: a causal inference approach in a case-control study.

PURPOSE: The association between high mammographic density (MD) and elevated breast cancer risk is well established. However, the role of absolute non-dense area remains unclear. We estimated the effect of the mammographic non-dense area and other density parameters on the risk of breast cancer. METHODS: This study utilizes data from a population-based case-control study conducted in Greater Vancouver, British Columbia, with 477 female postmenopausal breast cancer cases and 588 female postmenopausal controls. MD measures were determined from digitized screening mammograms using computer-assisted software (Cumulus). Marginal odds ratios were estimated by inverse-probability weighting using a causal diagram for confounder selection. Akaike information criteria and receiver operating characteristic curves were used to assess the goodness of fit and predictive power of unconditional logistic models containing MD parameters. RESULTS: The risk of breast cancer is 60% lower for the highest quartile compared to the lowest quartile of mammographic non-dense area (marginal OR 0.40, 95% CI 0.26-0.61, p-trend < 0.001). The cancer risk almost doubles for the highest quartile compared to the lowest quartile of dense area (marginal OR 1.81, 95% CI 1.19-2.43, p-trend < 0.001). For the highest quartile of percent density, breast cancer risk was more than three times higher than for the lowest quartile (marginal OR 3.15, 95% CI 1.90-4.40, p-trend < 0.001). No difference was seen in predictive accuracy between models using percent density alone, dense area alone, or non-dense area plus dense area. CONCLUSIONS: In this study, non-dense area is an independent risk factor after adjustment for dense area and other covariates, inversely related with the risk of breast cancer. However, non-dense area does not improve prediction over that offered by percent density or dense area alone.

Patient-reported factors associated with adherence to adjuvant endocrine therapy after breast cancer: an integrative review.

BACKGROUND: Adjuvant endocrine therapy (AET) significantly reduces recurrence and mortality in women with breast cancer (BrCa). Despite the efficacy of AET in improving BrCa outcomes, up to 50% of women do not adhere to prescribed AET regimens. While numerous demographic and clinical predictors influence adherence and persistence, few studies have identified the patient-reported factors that influence AET adherence and persistence. PURPOSE: The aim was to examine the patient-reported personal, social, and structural factors influencing BrCa survivors' adherence and persistence with AET. METHODS: An integrative review was undertaken wherein PubMed, Medline, CINAHL, Embase, and PsycINFO databases were searched using keyword descriptors and database subject headings. Inclusion criteria included quantitative or qualitative peer-reviewed studies written in English that assessed AET adherence and/or persistence through objective measurement or self-report and included patient-reported factors found to influence adherence and/or persistence. The data extracted from eligible studies were entered into a matrix, and systematically compared and iteratively analyzed using relational autonomy as an organizing theoretical framework. RESULTS: A total of 43 manuscripts (9 qualitative and 34 quantitative) were reviewed. Several personal, social, and structural factors were identified that influenced AET adherence and persistence, including side effects, necessity beliefs, self-efficacy, the patient-healthcare provider relationship, social support, and continuity of follow-up care. CONCLUSIONS: An increasing number of studies have focused on identifying the patient-reported factors that influence AET adherence and persistence. This review highlights important personal, social, and structural factors that act as facilitators and barriers in adhering to and persisting with long-term AET. Acknowledging and addressing these factors is key to providing women with the care needed to improve suboptimal adherence and persistence.

Determining activity count cut-points for measurement of physical activity using the Actiwatch2 accelerometer.

STUDY OBJECTIVES: Sleep and physical activity are important contributors to many aspects of health. Obtaining accurate, objective measures of both behaviours is critical to health research. The Actiwatch2 is a wrist-worn sleep-monitoring device that has the potential to measure physical activity. Currently, interpretation of the Actiwatch2 physical activity data is limited by a lack of published thresholds for interpreting exercise intensity. This limits the ability to collect information on both behaviours simultaneously using one monitor. This study aims to develop thresholds to differentiate between light, moderate and vigorous-intensity physical activity and sedentary time for the Actiwatch2. METHODS: Thirty females, 40±14.9years, completed eight exercise tasks while wearing a Cosmed portable metabolic cart, the Actiwatch2 and the Actigraph GT3X+. Correlations between 1) activity counts from both the Actiwatch2 and Actigraph and metabolic equivalent (MET) values, and 2) activity counts from the two monitors were calculated. Area Under the Curve (AUC) was calculated, and cut points that maximized sensitivity and specificity were determined. RESULTS: The correlations between MET values and Actiwatch2 counts (r=0.69) and Actigraph (r=0.69) were strong. Correlation between the two activity monitors was very strong (r=0.84). The discrimination of sedentary behaviour was almost perfect (AUC=0.96) using a threshold of 145cpm. Discrimination of moderate (AUC=0.92) and vigorous (AUC=0.77) activity was acceptable using a threshold of 274 and 597cpm respectively. CONCLUSIONS: The Actiwatch2 demonstrated the ability to discriminate different intensities of physical activity among adult females. With these reported cut points, the Actiwatch2 can be used to simultaneously measure sleep and physical activity - two key outcomes in health research.

Exploring the mediating roles of physical activity and television time on the relationship between the neighbourhood environment and childhood obesity.

OBJECTIVE: Understanding the mechanisms by which neighbourhood environments influence childhood obesity is needed to facilitate the development of prevention strategies. The objective of this cross-sectional study was to identify the distinct types of neighbourhoods in which Canadian children reside and examine the extent to which physical activity and sedentary behaviour mediate the relationship between neighbourhood type and childhood obesity. METHODS: Baseline data from the National Longitudinal Survey of Children and Youth (1994/1995) were used for this study. Latent class analysis was used to group children (age 0-11; N = 22,831) into neighbourhood types based on perceived and census-derived measures of neighbourhood attributes. A path analysis was used to determine the extent to which levels of physical activity and sedentary behaviour mediated the relationship between the resulting neighbourhood types and obesity. RESULTS: Five neighbourhood types were identified. Children living in the high safety-low deprivation neighbourhood type, which had the most supportive attributes with regard to physical activity, were significanlty less likely to be obese than children living in the other neighbourhood types. Relative to the high safety-low deprivation neighbourhood, the relationship between neighbourhood type and obesity was partially mediated by physical activity and sedentary behaviour (7%-12% of total effect) among the other urban neighbourhoods, and no mediating effect was found in the rural neighbourhood. CONCLUSIONS: Intervention strategies attempting to address the increased risk of obesity associated with neighbourhood environments should be tailored according to urban and rural setting and should consider taking a comprehensive approach aimed at improving a range of obesity-related behaviours.

Physical Activity, Physical Fitness, and Body Composition of Canadian Shift Workers: Data From the Canadian Health Measures Survey Cycles 1 and 2.

OBJECTIVES: The aim of the study was to compare objectively measured physical activity, sedentary time, physical fitness, and body composition in shift workers (SWs) with those who work regular days. METHODS: Population-based, cross-sectional data from the Canadian Health Measures Survey (n = 4323) were used. Univariate and multivariate linear and logistic regression models were used to compare outcomes between SWs and day workers. RESULTS: In unweighted analyses, SWs were more likely to have poor body composition, although had fewer minutes per week of sedentary time. Despite no differences in physical activity, SWs had a lower aerobic capacity. In weighted analyses, only differences in aerobic capacity were observed. CONCLUSIONS: This analysis confirms previous findings that SWs have poorer body composition than day workers, and suggest that SWs may need to engage in more physical activity to achieve the same aerobic capacity as day workers.

Acculturation and smoking in North Americans of Chinese ancestry: A systematic review.

OBJECTIVES: Many North American immigrants come from China. Given the critical impact of tobacco use on health, it is important to understand rates and correlates of smoking in this population. This systematic review addressed the question: based on current research, what is the association between acculturation and smoking behaviours in Chinese immigrants to North America? METHODS: The search was conducted in PubMed, Medline, Web of Science, and Academic Search Complete for papers published from 2005 to 2014. Data were extracted from Canadian and American studies for population characteristics, study design, measures of smoking and acculturation, and findings regarding smoking rates and associations between smoking and acculturation. SYNTHESIS: The literature search identified 147 articles, and 14 met inclusion criteria. Three studies were based on Canadian samples and the remaining 11 were from the United States. Of the 14 papers, 3 reported findings for youth and 11 for adults. Among adults, daily smoking rates were consistently much higher in men than women; for men, rates varied from 9% to 30%. Language use and time in North America were the most common indicators of acculturation. Almost all studies found a relationship between acculturation and smoking, such that more acculturated men smoke less and more acculturated women smoke more. CONCLUSION: The findings suggest that the association between acculturation and smoking is gender-specific. This correlation is found in youth and adults and in both Canada and the US. Increased acculturation has a protective effect on smoking for Chinese North American men, but a harmful effect for women. Tobacco control interventions need to develop targeted strategies appropriate to these different populations.

Body mass index trajectories from ages 1 to 20: Results from two nationally representative canadian longitudinal cohorts.

OBJECTIVE: In this study, unique body mass index (BMI) trajectories from ages 1 to 20 years were identified; each trajectory according to socio demographic and family characteristics was described. METHODS: Participants came from two national population surveys (n = 7,253; n = 901) and were aged 1-6 years at baseline. Children were surveyed biennially over eight waves up to 14-20 years of age. BMI trajectories by sex and survey cohort were identified by group-based trajectory modeling. After crossvalidating trajectories between survey cohorts, the characteristics of trajectory membership were assessed by multinomial regression. RESULTS: Four BMI trajectories were found: low, decreasing, medium, and high. The decreasing trajectory was characterized by an overweight or obese childhood followed by a normal-weight adolescence. The low, medium, and high trajectories were characterized by growth curves culminating, by age 20, to BMI 22.6, 29.3, and 34.9 kg/m(2) , respectively, for males and 20.6, 24.5, and 32.0 kg/m(2) , respectively, for females. Factors associated with the high trajectory included ethnicity and paternal education (female only), large for gestational age, rural area residence, and maternal smoking. CONCLUSIONS: The identification and validation of four major trajectories reflect the heterogeneity in patterns of BMI development from 1 to 20 years.

Health-related interventions among night shift workers: a critical review of the literature.

OBJECTIVES: Associations between shift work and chronic disease have been observed, but relatively little is known about how to mitigate these adverse health effects. This critical review aimed to (i) synthesize interventions that have been implemented among shift workers to reduce the chronic health effects of shift work and (ii) provide an overall evaluation of study quality. METHODS: MeSH terms and keywords were created and used to conduct a rigorous search of MEDLINE, CINAHL, and EMBASE for studies published on or before 13 August 2012. Study quality was assessed using a checklist adapted from Downs & Black. RESULTS: Of the 5053 articles retrieved, 44 met the inclusion and exclusion criteria. Over 2354 male and female rotating and permanent night shift workers were included, mostly from the manufacturing, healthcare, and public safety industries. Studies were grouped into four intervention types: (i) shift schedule; (ii) controlled light exposure; (iii) behavioral; and, (iv) pharmacological. Results generally support the benefits of fast-forward rotating shifts; simultaneous use of timed bright light and light-blocking glasses; and physical activity, healthy diet, and health promotion. Mixed results were observed for hypnotics. Study quality varied and numerous deficiencies were identified. CONCLUSIONS: Except for hypnotics, several types of interventions reviewed had positive overall effects on chronic disease outcomes. There was substantial heterogeneity among studies with respect to study sample, interventions, and outcomes. There is a need for further high-quality, workplace-based prevention research conducted among shift workers.

Complementary and alternative medicine use and breast cancer prognosis: a pooled analysis of four population-based studies of breast cancer survivors.

BACKGROUND: Complementary and alternative medicine (CAM) use is common among breast cancer survivors, but little is known about its impact on survival. METHODS: We pooled data from four studies conducted in Hawaii in 1994-2003 and linked to the Hawaii Tumor Registry to obtain long-term follow-up information. The effect of CAM use on the risk of breast cancer-specific death was evaluated using Cox regression. RESULTS: The analysis included 1443 women with a median follow-up of 11.8 years who had a primary diagnosis of in situ and invasive breast cancer. The majority were Japanese American (36.4%), followed by white (26.9%), Native Hawaiian (15.9%), other (10.6%), and Filipino (10.3%). CAM use was highest in Native Hawaiians (60.7%) and lowest in Japanese American (47.8%) women. Overall, any use of CAM was not associated with the risk of breast cancer-specific death (hazard ratio [HR] 1.47, confidence interval [CI] 0.91-2.36) or all-cause death (HR 0.82, 95% CI 0.63-1.06). However, energy medicine was associated with an increased risk of breast cancer-specific death (HR 3.19, 95% CI 1.06-8.52). When evaluating CAM use within ethnic subgroups, Filipino women who used CAM were at increased risk of breast cancer death (HR 6.84, 95% CI 1.23-38.19). CONCLUSIONS: Our findings suggest that, overall, CAM is not associated with breast cancer-specific death but that the effects of specific CAM modalities and possible differences by ethnicity should be considered in future studies.

Exercise interventions on health-related quality of life for cancer survivors.

BACKGROUND: Cancer survivors experience numerous disease and treatment-related adverse outcomes and poorer health-related quality of life (HRQoL). Exercise interventions are hypothesized to alleviate these adverse outcomes. HRQoL and its domains are important measures for cancer survivorship. OBJECTIVES: To evaluate the effectiveness of exercise on overall HRQoL and HRQoL domains among adult post-treatment cancer survivors. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, PEDRO, LILACS, SIGLE, SportDiscus, OTSeeker, and Sociological Abstracts from inception to October 2011 with no language or date restrictions. We also searched citations through Web of Science and Scopus, PubMed's related article feature, and several websites. We reviewed reference lists of included trials and other reviews in the field. SELECTION CRITERIA: We included all randomized controlled trials (RCTs) and controlled clinical trials (CCTs) comparing exercise interventions with usual care or other nonexercise intervention to assess overall HRQoL or at least one HRQoL domain in adults. Included trials tested exercise interventions that were initiated after completion of active cancer treatment. We excluded trials including people who were terminally ill, or receiving hospice care, or both, and where the majority of trial participants were undergoing active treatment for either the primary or recurrent cancer. DATA COLLECTION AND ANALYSIS: Five paired review authors independently extracted information on characteristics of included trials, data on effects of the intervention, and assessed risk of bias based on predefined criteria. Where possible, meta-analyses results were performed for HRQoL and HRQoL domains for the reported difference between baseline values and follow-up values using standardized mean differences (SMD) and a random-effects model by length of follow-up. We also reported the SMDs between mean follow-up values of exercise and control group. Because investigators used many different HRQoL and HRQoL domain instruments and often more than one for the same domain, we selected the more commonly used instrument to include in the SMD meta-analyses. We also report the mean difference for each type of instrument separately. MAIN RESULTS: We included 40 trials with 3694 participants randomized to an exercise (n = 1927) or comparison (n = 1764) group. Cancer diagnoses in study participants included breast, colorectal, head and neck, lymphoma, and other. Thirty trials were conducted among participants who had completed active treatment for their primary or recurrent cancer and 10 trials included participants both during and post cancer treatment. Mode of the exercise intervention included strength training, resistance training, walking, cycling, yoga, Qigong, or Tai Chi. HRQoL and its domains were measured using a wide range of measures.The results suggested that exercise compared with control has a positive impact on HRQoL and certain HRQoL domains. Exercise resulted in improvement in: global HRQoL at 12 weeks' (SMD 0.48; 95% confidence interval (CI) 0.16 to 0.81) and 6 months' (0.46; 95% CI 0.09 to 0.84) follow-up, breast cancer concerns between 12 weeks' and 6 months' follow-up (SMD 0.99; 95% CI 0.41 to 1.57), body image/self-esteem when assessed using the Rosenberg Self-Esteem scale at 12 weeks (MD 4.50; 95% CI 3.40 to 5.60) and between 12 weeks' and 6 months' (mean difference (MD) 2.70; 95% CI 0.73 to 4.67) follow-up, emotional well-being at 12 weeks' follow-up (SMD 0.33; 95% CI 0.05 to 0.61), sexuality at 6 months' follow-up (SMD 0.40; 95% CI 0.11 to 0.68), sleep disturbance when comparing follow-up values by comparison group at 12 weeks' follow-up (SMD -0.46; 95% CI -0.72 to -0.20), and social functioning at 12 weeks' (SMD 0.45; 95% CI 0.02 to 0.87) and 6 months' (SMD 0.49; 95% CI 0.11 to 0.87) follow-up. Further, exercise interventions resulted in decreased anxiety at 12 weeks' follow-up (SMD -0.26; 95% CI -0.07 to -0.44), fatigue at 12 weeks' (SMD -0.82; 95% CI -1.50 to -0.14) and between 12 weeks' and 6 months' (SMD -0.42; 95% CI -0.02 to -0.83) follow-up, and pain at 12 weeks' follow-up (SMD -0.29; 95% CI -0.55 to -0.04) when comparing follow-up values by comparison group.Positive trends and impact of exercise intervention existed for depression and body image (when analyzing combined instruments); however, because few studies measured these outcomes the robustness of findings is uncertain.No conclusions can be drawn regarding the effects of exercise interventions on HRQoL domains of cognitive function, physical functioning, general health perspective, role function, and spirituality.Results of the review need to be interpreted cautiously owing to the risk of bias. All the trials reviewed were at high risk for performance bias. In addition, the majority of trials were at high risk for detection, attrition, and selection bias. AUTHORS' CONCLUSIONS: This systematic review indicates that exercise may have beneficial effects on HRQoL and certain HRQoL domains including cancer-specific concerns (e.g. breast cancer), body image/self-esteem, emotional well-being, sexuality, sleep disturbance, social functioning, anxiety, fatigue, and pain at varying follow-up periods. The positive results must be interpreted cautiously due to the heterogeneity of exercise programs tested and measures used to assess HRQoL and HRQoL domains, and the risk of bias in many trials. Further research is required to investigate how to sustain positive effects of exercise over time and to determine essential attributes of exercise (mode, intensity, frequency, duration, timing) by cancer type and cancer treatment for optimal effects on HRQoL and its domains.

Feasibility of a lifestyle intervention on body weight and serum biomarkers in breast cancer survivors with overweight and obesity.

Physical inactivity and being overweight or obese are lifestyle factors that put breast cancer survivors at a higher risk for a cancer recurrence and/or development of other chronic diseases. Despite this, there is limited research that has identified effective lifestyle interventions aimed specifically at weight loss in breast cancer survivors. This pilot study is a single-arm experimental pre-post test design, conducted from November 2009 to July 2010, that tested the efficacy of a 24-week group-based lifestyle intervention modeled on the Diabetes Prevention Program in early stage breast cancer survivors (N=14). The intervention included 16 diet sessions led by a registered dietitian and 150 min/wk of moderate-to-vigorous exercise. Study outcome measures were completed at baseline, 24, and 36 weeks (nonintervention follow-up). The primary outcome was change in body weight, and secondary outcomes were change in body composition, aerobic fitness, dietary intake, and blood biomarkers. Overall, participants were postmenopausal women aged 54.6±8.3 years with obesity (body mass index 30.1±3.6), and had completed adjuvant cancer treatment 2 years prior. Results showed an average weight loss of 3.8±5.0 kg and a decrease in body mass index, percent body fat, and waist and hip circumferences at 24 weeks and an additional mean weight loss of 0.8±1.2 kg at 36 weeks. In exploratory analysis, participants who lost >7% body weight were older and attended a greater percentage of diet and supervised exercise sessions. There were no significant changes in any of the blood biomarkers at 24 and 36 weeks; however, the results provide a measure of expected effect size for future research studies. This pilot study demonstrated the efficacy of a lifestyle intervention based on the Diabetes Prevention Program in early stage breast cancer survivors and represents an innovative clinical intervention for dietetics practitioners to address the unmet need for programs.