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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 ). [ABSTRACT FROM AUTHOR]

Background: Advances in genomics offer promise for earlier detection or prevention of cancer, by personalisation of medical care tailored to an individual's genomic risk status. However genome sequencing can generate an unprecedented volume of results for the patient to process with potential implications for their families and reproductive choices. This paper describes a protocol for a study (PiGeOn) that aims to explore how patients and their blood relatives experience germline genomic sequencing, to help guide the appropriate future implementation of genome sequencing into routine clinical practice.Methods: We have designed a mixed-methods, prospective, cohort sub-study of a germline genomic sequencing study that targets adults with cancer suggestive of a genetic aetiology. One thousand probands and 2000 of their blood relatives will undergo germline genomic sequencing as part of the parent study in Sydney, Australia between 2016 and 2020. Test results are expected within12-15 months of recruitment. For the PiGeOn sub-study, participants will be invited to complete surveys at baseline, three months and twelve months after baseline using self-administered questionnaires, to assess the experience of long waits for results (despite being informed that results may not be returned) and expectations of receiving them. Subsets of both probands and blood relatives will be purposively sampled and invited to participate in three semi-structured qualitative interviews (at baseline and each follow-up) to triangulate the data. Ethical themes identified in the data will be used to inform critical revisions of normative ethical concepts or frameworks.Discussion: This will be one of the first studies internationally to follow the psychosocial impact on probands and their blood relatives who undergo germline genome sequencing, over time. Study results will inform ongoing ethical debates on issues such as informed consent for genomic sequencing, and informing participants and their relatives of specific results. The study will also provide important outcome data concerning the psychological impact of prolonged waiting for germline genomic sequencing. These data are needed to ensure that when germline genomic sequencing is introduced into standard clinical settings, ethical concepts are embedded, and patients and their relatives are adequately prepared and supported during and after the testing process. [ABSTRACT FROM AUTHOR]

Background: Lung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. People with lung cancer also report higher levels of symptom distress than those with other forms of cancer. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC.Methods: This multi-site, parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aims to assess functional and patient-reported outcomes of a multi-disciplinary, home-based exercise and supportive care program for people commencing treatment. Ninety-two participants are being recruited from three tertiary-care hospitals in Melbourne, Australia. Following baseline testing, participants are randomised using concealed allocation, to receive either: a) 8 weeks of home-based exercise (comprising an individualised endurance and resistance exercise program and behaviour change coaching) and nurse-delivered symptom self-management intervention or b) usual care. The primary outcome is the between-group difference in the change in functional exercise capacity (six-minute walk distance) from baseline to post-program assessment. Secondary outcomes include: objective and self-reported physical activity levels, physical activity self-efficacy, behavioural regulation of motivation to exercise and resilience, muscle strength (quadriceps and grip), health-related quality of life, anxiety and depression and symptom interference.Discussion: There is a lack of evidence regarding the benefit of exercise intervention for people with NSCLC, particularly in those with inoperable disease receiving treatment. This trial will contribute to evidence currently being generated in national and international trials by implementing and evaluating a home-based program including three components not yet combined in previous research, for people with inoperable NSCLC receiving active treatment and involving longer-term follow-up of outcomes. This trial is ongoing and currently recruiting.Trial Registration: This trial was prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12614001268639 : (4/12/14). [ABSTRACT FROM AUTHOR]

Background: Central venous access device (CVAD) associated complications are a preventable source of patient harm, frequently resulting in morbidity and delays to vital treatment. Dressing and securement products are used to prevent infectious and mechanical complications, however current complication rates suggest customary practices are inadequate. The aim of this study was to evaluate the feasibility of launching a full-scale randomized controlled efficacy trial of innovative dressing and securement products for pediatric tunneled CVAD to prevent complication and failure.Methods: An external, pilot, four-group randomized controlled trial of standard care (bordered polyurethane dressing and suture), in comparison to integrated securement-dressing, suture-less securement device, and tissue adhesive was undertaken across two large, tertiary referral pediatric hospitals in Australia. Forty-eight pediatric participants with newly inserted tunneled CVADs were consecutively recruited. The primary outcome of study feasibility was established by elements of eligibility, recruitment, attrition, protocol adherence, missing data, parent and healthcare staff satisfaction and acceptability, and effect size estimates for CVAD failure (cessation of function prior to completion of treatment) and complication (associated bloodstream infection, thrombosis, breakage, dislodgement or occlusion). Dressing integrity, product costs and site complications were also examined.Results: Protocol feasibility was established. CVAD failure was: 17% (2/12) integrated securement-dressing; 8% (1/13) suture-less securement device; 0% tissue adhesive (0/12); and, 0% standard care (0/11). CVAD complications were: 15% (2/13) suture-less securement device (CVAD associated bloodstream infection, and occlusion and partial dislodgement); 8% (1/12) integrated securement-dressing (partial dislodgement); 0% tissue adhesive (0/12); and, 0% standard care (0/11). One CVAD-associated bloodstream infection occurred, within the suture-less securement device group. Overall satisfaction was highest in the integrated securement-dressing (mean 8.5/10; standard deviation 1.2). Improved dressing integrity was evident in the intervention arms, with the integrated securement-dressing associated with prolonged time to first dressing change (mean days 3.5).Conclusions: Improving the security and dressing integrity of tunneled CVADs is likely to improve outcomes for pediatric patients. Further research is necessary to identify novel, effective CVAD securement to reduce complications, and provide reliable vascular access for children.Trial Registration: ACTRN12614000280606 ; prospectively registered on 17/03/2014. [ABSTRACT FROM AUTHOR]

Background: In 2017, the New South Wales Cancer Registry (NSWCR) participated in a project, supported by Cancer Australia, aiming to provide national stage data for melanoma, prostate, colorectal, breast, and lung cancers diagnosed in 2011. Simplified business rules based on the American Joint Committee for Cancer (AJCC) Tumour-Node-Metastasis (TNM) stage were applied to obtain Registry-Derived (RD) stage, defined as the best estimate of TNM stage at diagnosis using routine notifications available within cancer registries. RD-stage was compared with Degree of Spread (DoS), which has been recorded for all applicable cancers in NSWCR at a population-based level since 1972, and a summary AJCC-TNM stage group, which has been collected variably since 2006. For each of the five high incidence cancers, we compared the level of improvements RD-staging provided in terms of completeness and accuracy (alignment to more clinically relevant AJCC-TNM) over DoS.Methods: For each of the five cancers, stage data were extracted from NSWCR pre- and post- RD-staging to compare data completeness across all three staging systems. The alignment between DoS/RD-stage and AJCC-TNM was compared, as were the expected and observed cross-tabulated frequency distributions using a subset of NSWCR data. To determine differences between use of DoS, RD-stage, and AJCC-TNM in an epidemiological analysis, we compared survival models developed from each of the three stage variables.Results: We found RD-staging provided greatest stage data completeness and alignment to AJCC-TNM for prostate cancers, followed by breast, then melanoma and lung cancers. For colorectal cancer, summary stage from DoS was confirmed as an equivalent surrogate staging system to both AJCC-TNM and RD-stage.Conclusions: This analysis provides an evidence-based approach that can be used to inform decision-making for resource planning and potential implementation of a new stage data field in population-based cancer registries. [ABSTRACT FROM AUTHOR]

Background: Physical activity and consuming a healthy diet have clear benefits to the physical and psychosocial health of cancer survivors, with guidelines recognising the importance of these behaviors for cancer survivors. Interventions to promote physical activity and improve dietary behaviors among cancer survivors and carers are needed. The aim of this study was to determine the effects of a group-based, face-to-face multiple health behavior change intervention on behavioral outcomes among cancer survivors of mixed diagnoses and carers.Methods: The Exercise and Nutrition Routine Improving Cancer Health (ENRICH) intervention was evaluated using a two-group pragmatic randomized controlled trial. Cancer survivors and carers (n = 174) were randomly allocated to the face-to-face, group-based intervention (six, theory-based two-hour sessions delivered over 8 weeks targeting healthy eating and physical activity [PA]) or wait-list control (after completion of 20-week data collection). Assessment of the primary outcome (pedometer-assessed mean daily step counts) and secondary outcomes (diet and alcohol intake [Food Frequency Questionnaire], self-reported PA, weight, body mass index, and waist circumference) were assessed at baseline, 8-and 20-weeks.Results: There was a significant difference between the change over time in the intervention group and the control group. At 20 weeks, the intervention group had increased by 478 steps, and the control group had decreased by 1282 steps; this represented an adjusted mean difference of 1761 steps (184 to 3337; P = 0.0028). Significant intervention effects for secondary outcomes, included a half serving increase in vegetable intake (difference 39 g/day; 95 % CI: 12 to 67; P = 0.02), weight loss (kg) (difference -1.5 kg; 95 % CI, -2.6 to -0.3; P = 0.014) and change in body mass index (kg/m(2)) (difference -0.55 kg/m(2); 95 % CI, -0.97 to -0.13; P = 0.012). No significant intervention effects were found for self-reported PA, total sitting time, waist circumference, fruit, energy, fibre, alcohol, meat, or fat consumption.Conclusions: The ENRICH intervention was effective for improving PA, weight, body mass index, and vegetable consumption even with the inclusion of multiple cancer types and carers. As an example of successful research translation, the Cancer Council NSW has subsequently adopted ENRICH as a state-wide program.Trial Registration: Australian New Zealand Clinical Trials Register identifier: ANZCTRN1260901086257. [ABSTRACT FROM AUTHOR]