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 ).

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.

Alcohol and Breast Cancer: Results From the Women's Wellness After Cancer Program Randomized Controlled Trial.

BACKGROUND: There is evidence that drinking alcohol increases the risk of recurrent breast cancer. It is unclear whether Australian women with breast cancer are aware of this evidence or modify their alcohol intake accordingly. OBJECTIVE: This article reports a secondary analysis of data from the Women's Wellness after Cancer Program (WWACP) randomized controlled trial (N = 351). The WWACP aimed to enhance quality of life and reduce chronic disease risk in women previously treated for cancer through lifestyle modification. Here we provide the alcohol-related data from the study's breast cancer participants (n = 269). We analyzed baseline alcohol consumption, the variables associated with alcohol intake, and intervention effect on intake at weeks 12 (end of intervention) and 24 (to determine sustainability). INTERVENTIONS/METHODS: Measures included the Dietary Questionnaire for Epidemiological Studies, Short Form-36, International Physical Activity Questionnaire, Green Climacteric Scale, Pittsburgh Sleep Quality Index, and Center for Epidemiologic Studies Depression Scale. RESULTS: Most participants practiced safe alcohol consumption. Among drinkers, drinking caffeine, smoking, emotional and physical role limitations, and greater discomfort with vasomotor symptoms were associated with increased intake. Relative to baseline, alcohol consumption decreased from 5.22 g/d to 4.18 g/d in the intervention group, whereas consumption increased among control subjects at 12 weeks. No difference between groups was observed at week 24. CONCLUSION: The intervention was associated with less alcohol intake at week 12 among drinkers, but this reduction was not sustained at the 24-week follow-up. IMPLICATIONS FOR PRACTICE: Future iterations of the WWACP will emphasize stronger messaging and supports regarding alcohol consumption after breast cancer treatment.

Physical activity and menopausal symptoms in women who have received menopause-inducing cancer treatments: results from the Women's Wellness After Cancer Program.

OBJECTIVE: This randomized controlled trial tested a digitally-delivered whole-of-lifestyle program for women previously treated for cancer. We investigated (1) associations between self-reported physical activity (PA) and menopausal symptoms and (2) if the intervention was associated with beneficial changes in PA and menopausal symptoms. METHODS: Women were randomized to intervention (n = 142) or control (n = 138). The intervention targeted lifestyle behavior including PA. Self-reported PA (International Physical Activity Questionnaire - Short Form) and menopausal symptom (Green Climacteric Scale, GCS) data were collected at baseline, with measures repeated at 12 weeks (end of intervention) and 24 weeks (to assess sustainability). Generalized estimating equation models explored associations between PA and GCS scores. Mixed-effects generalized equation models analyzed changes within and between groups in PA and GCS scores. RESULTS: Total GCS scores were 1.83 (95% CI: 0.11-3.55) and 2.72 (95% CI: 1.12-4.33) points lower in women with medium and high levels of PA, respectively, than in women with low levels of PA. Total average GCS scores were 1.02 (0.21-2.26) and 1.61 (0.34-2.87) points lower in those undertaking moderate or vigorous intensity PA, respectively. Time spent walking, and performing moderate and vigorous PA were not different between intervention and control. The average GCS decrease of 0.66 points (95% CI: 0.03-1.29; p time = 0.03) over 24 weeks was not different between groups. CONCLUSION: This exploratory study established a stepwise association between moderate and vigorous PA and a lower total menopausal symptom score. The intervention did not appear to increase self-reported PA in women treated for early stage breast, reproductive, and blood cancers.

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.

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.

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.

APPETITE PREDICTS INTAKE AND NUTRITIONAL STATUS IN PATIENTS RECEIVING PERITONEAL DIALYSIS.

BACKGROUND: Sub-optimal nutrition status is common amongst patients receiving peritoneal dialysis (PD) and leads to poor clinical outcome. This population experiences multi-factorial challenges to achieving optimal nutritional status, particularly driven by inadequate intake. OBJECTIVES: The aim of this investigation was to identify factors associated with inadequate protein intake and sub-optimal nutritional status in patients undergoing PD. DESIGN/PARTICIPANTS: This was a cross-sectional study of 67 adult patients receiving PD (mean age 59 ± 14 years; 57% male) within a single centre. Participants were consecutively recruited and interviewed by renal dietitians, collecting: Subjective Global Assessment (SGA); quality of life (using EQ-5D); dietary intake (via dietary interview); and appetite (using Appetite and Diet Assessment Tool). Participant demographics were obtained via survey or medical charts. Main outcome measures were inadequate dietary protein intake (<1.1 g/kg adjusted body weight/day) and malnutrition (as defined by SGA rating B or C). RESULTS: Overall, 15 (22%) patients were malnourished and 29 (43%) had inadequate protein intake. Poor appetite (anorexia) was reported in 62% (18/29) of participants with inadequate protein malnourished patients reported anorexia versus 12 (23%) of the well-nourished patients (p = 0.0001). CONCLUSION: Anorexia was a key risk factor for inadequate protein intake and malnutrition in patients undergoing PD. These findings highlight a need to closely monitor patients with appetite disturbances.