Improving health-related quality of life in women with breast, blood, and gynaecological Cancer with an eHealth-enabled 12-week lifestyle intervention: the women's wellness after Cancer program randomised controlled trial.

BACKGROUND: The residual effects of cancer and its treatment can profoundly affect women's quality of life. This paper presents results from a multisite randomized controlled trial that evaluated the clinical benefits of an e-health enabled health promotion intervention (the Women's Wellness after Cancer Program or WWACP) on the health-related quality of life of women recovering from cancer treatment. METHODS: Overall, 351 women previously treated for breast, blood or gynaecological cancers were randomly allocated to the intervention (WWACP) or usual care arms. The WWACP comprised a structured 12-week program that included online coaching and an interactive iBook that targeted physical activity, healthy diet, stress and menopause management, sexual wellbeing, smoking cessation, alcohol intake and sleep hygiene. Data were collected via a self-completed electronic survey at baseline (t0), 12 weeks (post-intervention, t1) and 24 weeks (to assess sustained behaviour change, t2). The primary outcome, health-related quality of life (HRQoL), was measured using the Short Form Health Survey (SF-36). RESULTS: Following the 12-week lifestyle program, intervention group participants reported statistically significant improvements in general health, bodily pain, vitality, and global physical and mental health scores. Improvements were also noted in the control group across several HRQoL domains, though the magnitude of change was less. CONCLUSIONS: The WWACP was associated with improved HRQoL in women previously treated for blood, breast, and gynaecological cancers. Given how the synergy of different lifestyle factors influence health behaviour, interventions accounting for the reciprocity of multiple health behaviours like the WWACP, have real potential for immediate and sustainable change. TRIAL REGISTRATION: The protocol for this randomised controlled trial was submitted to the Australian and New Zealand Clinical Trials Registry on 15/07/2014 and approved on 28/07/2014 ( ACTRN12614000800628 ).

Improving the health-related quality of life of adult Nigerians living with cancer and their family caregivers: intervention development.

BACKGROUND: Evidence for the effectiveness of interventions aimed at improving the health-related quality of life of people living with cancer and/or family members is compelling. However, most interventional research has been conducted in high-income countries, and no intervention had been tested in low-income countries such as Nigeria. It is critical to design a culturally theory-based intervention in a resource-poor setting to address the needs and support coping strategies of cancer patients and their family caregivers. METHODS: Theory, evidence, and practical issues were considered. The Medical Research Council framework for developing and evaluating complex interventions and Behaviour Change Wheel provided the framework for intervention design. Findings generated by a needs assessment of adult Nigerians with cancer and their family caregivers and relevant theories (the Spirituality and the Supportive Care Framework for Cancer) informed content development. RESULTS: A theory-based, culturally tailored socio-spiritual intervention was developed to address the specific needs of adult Nigerians with cancer and their family caregivers. A 4-week intervention included strategies designed to improve social and spiritual support, information and health literacy, and health-related quality of life. CONCLUSIONS: A systemic approach was used to conceptualise an evidence-based and theory-informed intervention tailored to address previously identified shortfalls in support available to adults living with cancer and their family caregivers, in Nigeria. If implemented and effective, such an intervention has the potential to improve the health-related quality of life of people living with cancer and their families in Nigeria.

Determining the psychometric properties of the Greene Climacteric Scale (GCS) in women previously treated for breast cancer: A pooled analysis of data from the Women's Wellness after Cancer Programs.

OBJECTIVES: This paper examines the utility of a common climacteric symptoms scale, the Greene Climacteric Scale (GCS), in two groups of women with a history of breast cancer, those who were at menopause before commencing breast cancer treatment, and those who were not. STUDY DESIGN: This pooled analysis of 297 women previously diagnosed with breast cancer, aged 28-74 years, was undertaken on baseline data from two structured lifestyle interventions: the Women's Wellness After Cancer Program (WWACP) and the Younger Women's Wellness After Cancer Program (YWWACP). Data were split into two data subsets (women who were post-menopausal on commencement of breast cancer treatment and those who were either pre- or peri­menopausal). Multitrait/multi-item analysis was conducted to test scaling assumptions for each group separately. RESULTS: GCS domain scores were positively skewed, with significant floor effects for vasomotor symptoms and ceiling effects for sexual dysfunction. Multitrait analysis showed acceptable convergent validity (77% of items correlated ≥ 0.40 with their hypothesized domains) but weak discriminant validity for anxiety, depression, and somatic symptoms in both groups. The exploratory factor analysis in women who were menopausal at the commencement of breast cancer treatment and those who were not revealed distinct factor structures that accounted for 60.2% and 62.7% of the total variance, respectively. CONCLUSIONS: The original GCS factor structure was not replicated in this sample. Among women previously treated for breast cancer, the presence of multiple concurrent and severe menopausal symptoms with possible treatment-related causes underpins the need for a breast cancer-specific measure to enhance their identification and management. TRIAL IDS, AUSTRALIAN AND NEW ZEALAND CLINICAL TRIALS REGISTRY: WWACP, ACTRN12614000800628; YWWACP, ACTRN12614001087640.

Involvement of Pro-Inflammatory Macrophages in Liver Pathology of Pirital Virus-Infected Syrian Hamsters.

New World arenaviruses cause fatal hemorrhagic disease in South America. Pirital virus (PIRV), a mammarenavirus hosted by Alston’s cotton rat (Sigmodon alstoni), causes a disease in Syrian golden hamsters (Mesocricetus auratus) (biosafety level-3, BSL-3) that has many pathologic similarities to the South American hemorrhagic fevers (BSL-4) and, thus, is considered among the best small-animal models for human arenavirus disease. Here, we extend in greater detail previously described clinical and pathological findings in Syrian hamsters and provide evidence for a pro-inflammatory macrophage response during PIRV infection. The liver was the principal target organ of the disease, and signs of Kupffer cell involvement were identified in mortally infected hamster histopathology data. Differential expression analysis of liver mRNA revealed signatures of the pro-inflammatory response, hematologic dysregulation, interferon pathway and other host response pathways, including 17 key transcripts that were also reported in two non-human primate (NHP) arenavirus liver-infection models, representing both Old and New World mammarenavirus infections. Although antigen presentation may differ among rodent and NHP species, key hemostatic and innate immune-response components showed expression parallels. Signatures of pro-inflammatory macrophage involvement in PIRV-infected livers included enrichment of Ifng, Nfkb2, Stat1, Irf1, Klf6, Il1b, Cxcl10, and Cxcl11 transcripts. Together, these data indicate that pro-inflammatory macrophage M1 responses likely contribute to the pathogenesis of acute PIRV infection.

Life stress and symptoms of anxiety and depression in women after cancer: The mediating effect of stress appraisal and coping.

OBJECTIVE: This paper examines the direct and intermediary relationships between life stress, stress appraisal, and resilience, and increased anxiety and depressive symptoms in Australian women after cancer treatment. METHODS: Data examined from 278 women aged 18 years and older previously treated for breast, gynaecological, or blood cancer, participating in the Australian Women's Wellness after Cancer Program. Serial mediation models interrogated the effect of stressful life events (List of Threatening Experiences-Modified) mediated by appraisal and coping (Perceived Stress Scale and Connor-Davidson Resilience Scale), on symptoms of anxiety and depression (Zung Self-rating Anxiety Scale and Center for Epidemiologic Studies Depression Scale). RESULTS: Over one-quarter (30.2%) of participants reported 1 or more stressful life events, other than their cancer, in the previous 6 months. Results indicate that perceived stress fully mediated the relationships between life stress, anxiety (indirect effect = 0.09, Bias-corrected bootstrap 95% CI 0.02-0.18, Percent mediation = 0.51), and depressive symptoms (indirect effect = 0.11, Bias-corrected bootstrap 95% CI 0.02-0.23, Percent mediation = 0.71) and accounted for more than half of the relationship between predictor and outcome. CONCLUSIONS: Findings indicate that stress appraisal mediated the relationship between past life stressors and anxiety and depressive symptoms. This analysis also highlights the need to consider wellness within a broader care context to identify potentially vulnerable patients to possibly avert future health concerns.

Exposure to stress across the life course and its association with anxiety and depressive symptoms: Results from the Australian Women's Wellness After Cancer Program (WWACP).

OBJECTIVES: Earlier life stressors can increase the risk of persistent anxiety and depressive symptoms in women after cancer, though our understanding of the underlying mechanisms is limited. In this study, we tested alternative life course models to determine which best described associations between exposure to stressors in childhood, adolescence, and adulthood, and self-reported health in women previously treated for breast, gynaecological, and blood cancer. STUDY DESIGN: Data were drawn from 351 Australian women within 2 years of completing active cancer treatment who were participating in the Women's Wellness After Cancer Program (WWACP) randomised controlled trial. A model-building framework compared "accumulative risk" and "sensitive period" stress exposure hypotheses with the saturated model to determine best fit. MAIN OUTCOME MEASURES: Symptoms of anxiety and depression were measured using the Center for Epidemiologic Studies Depression Scale (CES-D) and the Zung Self-rating Anxiety Scale (SAS). RESULTS: Participants with the greatest number of stressful life events (SLEs) reported higher anxiety scores and more depressive symptoms. Alternative life course models for psychological distress (measured through the CES-D and SAS) and stress were compared with the saturated model (i.e., the accumulative risk). The more restrictive "sensitive period" models were the best fit for depressive symptoms though none was significantly better than another. In contrast, an "early sensitive" model provided the best fit for anxiety data. CONCLUSIONS: Anxiety scores were higher in women with early life stressors. This study highlights the need for whole-of-life supportive care approaches for women previously treated for cancer, which should include targeted strategies for effective management of stress, anxiety and depression.

Analysis of early mesothelial cell responses to Staphylococcus epidermidis isolated from patients with peritoneal dialysis-associated peritonitis.

The major complication of peritoneal dialysis (PD) is the development of peritonitis, an infection within the abdominal cavity, primarily caused by bacteria. PD peritonitis is associated with significant morbidity, mortality and health care costs. Staphylococcus epidermidis is the most frequently isolated cause of PD-associated peritonitis. Mesothelial cells are integral to the host response to peritonitis, and subsequent clinical outcomes, yet the effects of infection on mesothelial cells are not well characterised. We systematically investigated the early mesothelial cell response to clinical and reference isolates of S. epidermidis using primary mesothelial cells and the mesothelial cell line Met-5A. Using an unbiased whole genome microarray, followed by a targeted panel of genes known to be involved in the human antibacterial response, we identified 38 differentially regulated genes (adj. p-value < 0.05) representing 35 canonical pathways after 1 hour exposure to S. epidermidis. The top 3 canonical pathways were TNFR2 signaling, IL-17A signaling, and TNFR1 signaling (adj. p-values of 0.0012, 0.0012 and 0.0019, respectively). Subsequent qPCR validation confirmed significant differences in gene expression in a number of genes not previously described in mesothelial cell responses to infection, with heterogeneity observed between clinical isolates of S. epidermidis, and between Met-5A and primary mesothelial cells. Heterogeneity between different S. epidermidis isolates suggests that specific virulence factors may play critical roles in influencing outcomes from peritonitis. This study provides new insights into early mesothelial cell responses to infection with S. epidermidis, and confirms the importance of validating findings in primary mesothelial cells.

The Women's wellness after cancer program: a multisite, single-blinded, randomised controlled trial protocol.

BACKGROUND: Despite advances in cancer diagnosis and treatment have significantly improved survival rates, patients post-treatment-related health needs are often not adequately addressed by current health services. The aim of the Women's Wellness after Cancer Program (WWACP), which is a digitised multimodal lifestyle intervention, is to enhance health-related quality of life in women previously treated for blood, breast and gynaecological cancers. METHODS: A single-blinded, multi-centre randomized controlled trial recruited a total of 351 women within 24 months of completion of chemotherapy (primary or adjuvant) and/or radiotherapy. Women were randomly assigned to either usual care or intervention using computer-generated permuted-block randomisation. The intervention comprises an evidence-based interactive iBook and journal, web interface, and virtual health consultations by an experienced cancer nurse trained in the delivery of the WWACP. The 12 week intervention focuses on evidence-based health education and health promotion after a cancer diagnosis. Components are drawn from the American Cancer Research Institute and the World Cancer Research Fund Guidelines (2010), incorporating promotion of physical activity, good diet, smoking cessation, reduction of alcohol intake, plus strategies for sleep and stress management. The program is based on Bandura's social cognitive theoretical framework. The primary outcome is health-related quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes are menopausal symptoms as assessed by Greene Climacteric Scale; physical activity elicited with the Physical Activity Questionnaire Short Form (IPAQ-SF); sleep measured by the Pittsburgh Sleep Quality Index; habitual dietary intake monitored with the Food Frequency Questionnaire (FFQ); alcohol intake and tobacco use measured by the Australian Health Survey and anthropometric measures including height, weight and waist-to-hip ratio. All participants were assessed with these measures at baseline (at the start of the intervention), 12 weeks (at completion of the intervention), and 24 weeks (to determine the level of sustained behaviour change). Further, a simultaneous cost-effectiveness evaluation will consider if the WWACP provides value for money and will be reported separately. DISCUSSION: Women treated for blood, breast and gynaecological cancers demonstrate increasingly good survival rates. However, they experience residual health problems that are potentially modifiable through behavioural lifestyle interventions such as the WWACP. TRIAL REGISTRATION: The protocol for this study was registered with the Australian and New Zealand Clinical Trials Registry, Trial ID: ACTRN12614000800628 , July 28, 2014.

Menopausal symptom clusters and their correlates in women with and without a history of breast cancer: a pooled data analysis from the Women's Wellness Research Program.

OBJECTIVES: This analysis examined climacteric symptoms clusters in women with and without breast cancer, and explored how sociodemographic, health, and modifiable lifestyle factors predicted symptom clusters. METHODS: This pooled analysis of four Women's Wellness Research Program (WWRP) studies comprised individual-level data from 969 Australian women aged 40 to 63 years, 293 of whom had been previously treated for breast cancer and 678 without a breast cancer history. Climacteric symptoms, menopausal status, sociodemographic characteristics, and health and lifestyle factors were assessed. Principal component analysis was used to determine symptom clusters for each group separately before linear regression with backwards selection was used to identify the significant correlates of the identified clusters. RESULTS: Women with a history of breast cancer reported more sleep disturbance (P < 0.01), difficulty concentrating (P < 0.01), muscular/joint pain (P < 0.01), crying (P < 0.01) and irritability (P < 0.01), and vasomotor symptoms (P < 0.01) than women from the noncancer group. Principal component analysis with quartimax rotation revealed two distinct solutions explaining 60.9% and 57.6% of the variance in the groups, respectively. For both groups, symptom clusters were increased among those with unhealthy lifestyle behaviors (and chemotherapy among the after cancer group, P < 0.05 for all), though to a lesser extent in the breast cancer group. CONCLUSIONS: In this study, women after treatment for breast cancer reported a broad range of bothersome climacteric symptoms. Similar symptom clusters were also noted for women with and without a history of breast cancer, though correlates differed across groups, and might reflect different underlying etiologies.

Factors predicting barriers to exercise in midlife Australian women.

OBJECTIVES: Chronic diseases are the leading cause of death and disability worldwide. They are, though, largely attributable to modifiable lifestyle risk factors, including lack of exercise. This study aims to investigate what factors predict perceptions of barriers to exercise in midlife women. STUDY DESIGN: This cross-sectional descriptive study collected data from midlife Australian women by online questionnaire. Volunteers aged between 40 and 65 years were recruited following media publicity about the study. MAIN OUTCOME MEASURES: The primary outcome measure was perceived exercise barriers (EBBS Barriers sub-scale). Other self-report data included: exercise, smoking, alcohol, fruit and vegetable consumption, body mass index, physical and mental health and well-being (MOS SF-12v2) and exercise self-efficacy. RESULTS: On average, the 225 participants were aged 50.9 years (SD=5.9). The significant predictors of perceived barriers to exercise were perceived benefits of exercise, exercise self-efficacy, physical well-being and mental well-being. These variables explained 41% of the variance in the final model (F (8219)=20.1, p<.01) CONCLUSIONS: In midlife women, perceptions of barriers to exercise correlate with beliefs about the health benefits of exercise, exercise self-efficacy, physical and mental well-being. These findings have application to health promotion interventions targeting exercise behaviour change in midlife women.

Decreasing menopausal symptoms in women undertaking a web-based multi-modal lifestyle intervention: The Women's Wellness Program.

Menopausal transition can be challenging for many women. This study tested the effectiveness of an intervention delivered in different modes in decreasing menopausal symptoms in midlife women. The Women's Wellness Program (WWP) intervention was delivered to 225 Australian women aged between 40 and 65 years through three modes (i.e., on-line independent, face-to-face with nurse consultations, and on-line with virtual nurse consultations). All women in the study were provided with a 12-week Program Book outlining healthy lifestyle behaviors while women in the consultation groups were supported by a registered nurse who provide tailored health education and assisted with individual goal setting for exercise, healthy eating, smoking and alcohol consumption. Pre- and post-intervention data were collected on menopausal symptoms (Greene Climacteric Scale), health related quality of life (SF12), and modifiable lifestyle factors. Linear mixed-effect models showed an average 0.87 and 1.23 point reduction in anxiety (p<0.01) and depression scores (p<0.01) over time in all groups. Results also demonstrated reduced vasomotor symptoms (ß=-0.19, SE=0.10, p=0.04) and sexual dysfunction (ß=-0.17, SE=0.06, p<0.01) in all participants though women in the face-to-face group generally reported greater reductions than women in the other groups. This lifestyle intervention embedded within a wellness framework has the potential to reduce menopausal symptoms and improve quality of life in midlife women thus potentially enhancing health and well-being in women as they age. Of course, study replication is needed to confirm the intervention effects.

Facilitating lifestyle changes to manage menopausal symptoms in women with breast cancer: a randomized controlled pilot trial of The Pink Women's Wellness Program.

OBJECTIVE: Women diagnosed as having breast cancer may experience difficulties with posttreatment effects such as menopausal symptoms. The aims of this pilot study were to (1) evaluate the impact of a multimodal lifestyle program on reducing menopausal symptoms in women with breast cancer and (2) examine the impact of the program on health-related quality of life (HRQoL) and adherence to lifestyle recommendations. METHODS: Overall, 55 women aged 45 to 60 years with one moderate to severe menopausal symptom and a history of breast cancer were randomized into an intervention group (n = 26) or a control group (n = 29). Women in the intervention group received a lifestyle intervention (The Pink Women's Wellness Program) that included clinical consultations and a tailored health education program. Measurements of menopausal symptoms (Greene Climacteric Scale), HRQoL (SF-12 and Functional Assessment of Cancer Therapy-Breast), and modifiable lifestyle factors (food intake, physical activity, smoking and alcohol use, and sleep disturbance) were taken at baseline and 12 weeks. RESULTS: Women in the intervention group reported clinically significant reductions in many menopausal symptoms, specifically somatic symptoms (d = 0.52), vasomotor symptoms (d = 0.55), sexual dysfunction (d = .65), and overall menopausal symptoms (d = 0.54), at 12 weeks compared with the control group (d = 0.03, d = 0.24, d = 0.18, and d = 0.05, respectively). Women in the intervention group reported improvements in Functional Assessment of Cancer Therapy-Breast subscale scores, physical well-being and functional well-being, and Functional Assessment of Cancer Therapy-General total scores (intervention group: d = 0.54, d = 0.50, and d = 0.48, respectively; control group: d = 0.22, d = 0.11, and d = 0.05, respectively). CONCLUSIONS: The Pink Women's Wellness Program is effective in decreasing menopausal symptoms, thus improving HRQoL. This being a pilot study, further research is recommended to investigate the benefits of combining nonpharmacological interventions for women with breast cancer to reduce their treatment-related menopausal symptoms.

Perceived barriers to healthy lifestyle activities in midlife and older Australian women with type 2 diabetes.

BACKGROUND: Type 2 diabetes is a leading cause of morbidity and mortality in midlife and older Australian women with known modifiable risk factors for type 2 diabetes including smoking, nutrition, physical activity and obesity. In Australia little research has been done to investigate the perceived barriers to healthy lifestyle activities in midlife and older women with type 2 diabetes. AIMS: The primary aim of this study was to explore the level and type of perceived barriers to health promotion activities. The secondary aim was to explore the relationship of perceived barriers to smoking behaviour, fruit and vegetable intake, physical activity, and body mass index. METHODS: The study was a cross sectional survey of women, aged over 45 with type 2 diabetes, recruited from four metropolitan community health clinics (n = 41). Data were collected from self-report questionnaires and analysed using quantitative methods. RESULTS: Women in the study had average total barriers scores similar to those reported in the literature for women with a range of physical disabilities and illnesses. The leading barriers for this group of women were: lack of interest, concern about safety, too tired, lack of money and feeling what they do does not help. There was no association between total barriers scores and body mass index, physical activity, fruit and vegetable intake or socio-demographic variables. CONCLUSION: This study contributes to understanding the perceptions of midlife and older women with type 2 diabetes about the level and type of barriers to healthy lifestyle activities that they experience. The participants reported a high level perceived barriers with a range of personal, social and environmental issues identified and described. This study suggests that health promo- tion education and interventions for risk factor reduction in women with type 2 diabetes may be enhanced by explicitly addressing perceived barriers to healthy lifestyle activities.