Challenges and solutions to cancer-related financial toxicity according to Australian health professionals: qualitative results from a national survey.

PURPOSE: To qualitatively explore Australian healthcare professionals' perspectives on how to improve the care and management of cancer-related financial toxicity, including relevant practices, services, and unmet needs. METHODS: We invited healthcare professionals (HCP) who currently provide care to people with cancer within their role to complete an online survey, which was distributed via the networks of Australian clinical oncology professional associations/organisations. The survey was developed by the Clinical Oncology Society of Australia's Financial Toxicity Working Group and contained 12 open-ended items which we analysed using descriptive content analysis and NVivo software. RESULTS: HCPs (n = 277) believed that identifying and addressing financial concerns within routine cancer care was important and most believed this to be the responsibility of all HCP involved in the patient's care. However, financial toxicity was viewed as a "blind spot" within a medical model of healthcare, with a lack of services, resources, and training identified as barriers to care. Social workers reported assessment and advocacy were part of their role, but many reported lacking formal training and understanding of financial complexities/laws. HCPs reported positive attitudes towards transparent discussions of costs and actioning cost-reduction strategies within their control, but feelings of helplessness when they perceived no solution was available. CONCLUSION: Identifying financial needs and providing transparent information about cancer-related costs was viewed as a cross-disciplinary responsibility, however, a lack of training and services limited the provision of support. Increased cancer-specific financial counselling and advocacy, via dedicated roles or developing HCPs' skills, is urgently needed within the healthcare system.

Financial well-being as a mediator of the relationship between multimorbidity and health-related quality of life in people with cancer.

BACKGROUND: It is unknown whether financial well-being mediates the impact of multimorbidity on the health-related quality of life (HRQoL) of cancer patients. METHODS: Participants were recruited from three outpatient oncology clinics of Hong Kong public hospitals. Multimorbidity was assessed using the Charlson Comorbidity Index. Financial well-being, the mediator of the association between multimorbidity and HRQoL outcomes, was assessed using the Comprehensive Score for Financial Toxicity Functional Assessment of Chronic Illness Therapy. The HRQoL outcomes were assessed using the Functional Assessment of Cancer Therapy - General (FACT-G) and its four sub-dimensions. Mediation analyses were conducted using SPSS PROCESS v4.1. RESULTS: Six-hundred and forty cancer patients participated in the study. Multimorbidity had a direct effect on FACT-G scores independent of financial well-being (ß for path c' = -0.752, p < 0.001). In addition, multimorbidity had an indirect effect on FACT-G scores through its effect on financial well-being (ß for path a = -0.517, p < 0.05; ß for path b = 0.785, p < 0.001). Even after adjustments were made for the covariates, the indirect effect of multimorbidity on FACT-G via financial well-being remained significant, accounting for 38.0% of the overall effect, indicating partial mediation. Although there were no statistically significant associations between multimorbidity, social well-being, and emotional well-being, the indirect effects of multimorbidity on physical and functional well-being through financial well-being remained significant. CONCLUSIONS: Poor financial well-being attributable to multimorbidity partially mediates the direct impact of chronic conditions on HRQoL in Chinese cancer patients, particularly their physical and functional well-being.

Patient navigation across the cancer care continuum: An overview of systematic reviews and emerging literature.

Patient navigation is a strategy for overcoming barriers to reduce disparities and to improve access and outcomes. The aim of this umbrella review was to identify, critically appraise, synthesize, and present the best available evidence to inform policy and planning regarding patient navigation across the cancer continuum. Systematic reviews examining navigation in cancer care were identified in the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, Cumulative Index of Nursing and Allied Health (CINAHL), Epistemonikos, and Prospective Register of Systematic Reviews (PROSPERO) databases and in the gray literature from January 1, 2012, to April 19, 2022. Data were screened, extracted, and appraised independently by two authors. The JBI Critical Appraisal Checklist for Systematic Review and Research Syntheses was used for quality appraisal. Emerging literature up to May 25, 2022, was also explored to capture primary research published beyond the coverage of included systematic reviews. Of the 2062 unique records identified, 61 systematic reviews were included. Fifty-four reviews were quantitative or mixed-methods reviews, reporting on the effectiveness of cancer patient navigation, including 12 reviews reporting costs or cost-effectiveness outcomes. Seven qualitative reviews explored navigation needs, barriers, and experiences. In addition, 53 primary studies published since 2021 were included. Patient navigation is effective in improving participation in cancer screening and reducing the time from screening to diagnosis and from diagnosis to treatment initiation. Emerging evidence suggests that patient navigation improves quality of life and patient satisfaction with care in the survivorship phase and reduces hospital readmission in the active treatment and survivorship care phases. Palliative care data were extremely limited. Economic evaluations from the United States suggest the potential cost-effectiveness of navigation in screening programs.

Top 10 Tips for Research Grant Writing: A Guide for Nurses and Allied Health Professionals.

OBJECTIVES: Nurses and allied health professionals have traditionally received less of the health and medical competitive research funding pool compared with medical practitioners and basic scientists. This instructive article aims to facilitate greater success rates by providing top 10 tips on good grantsmanship, which may serve as a guide for clinician researchers with limited experience with successful grant applications. DATA SOURCES: Expert advice was used to write this article. CONCLUSION: A quality grant application requires considerable time and investment. The top 10 tips include: (1) understanding the grant scheme; (2) partnering with the right mentor; (3) assembling the best team; (4) providing a case for novelty, significance, and urgency; (5) maximizing feasibility, scientific quality, and innovations; (6) providing evidence and data to substantiate claims; (7) ensuring points of difference; (8) clarifying return on investment; (9) ensuring perfect presentation and formatting; and (10) incorporating critical feedback. IMPLICATIONS FOR NURSING PRACTICE: Each grant scheme can have different focuses and selection criteria. However, these top tips can be used as a guide to consider in maximizing success for nurse-led and allied health led research.

Opinions and strategies of Australian health professionals on tackling cancer-related financial toxicity: A nationwide survey.

AIM: To understand the opinions and current practices of health professionals on the topic of addressing cancer-related financial toxicity among patients. METHODS: A cross-sectional online survey was distributed through Australian clinical oncology professional organizations/networks. The multidisciplinary Clinical Oncology Society of Australia Financial Toxicity Working Group developed 25 questions relating to the frequency and comfort levels of patient-clinician discussions, opinions about their role, strategies used, and barriers to providing solutions for patients. Descriptive statistics were used and subgroup analyses were undertaken by occupational groups. RESULTS: Two hundred and seventy-seven health professionals completed the survey. The majority were female (n = 213, 77%), worked in public facilities (200, 72%), and treated patients with varied cancer types across all of Australia. Most participants agreed that it was appropriate in their clinical role to discuss financial concerns and 231 (88%) believed that these discussions were an important part of high-quality care. However, 73 (28%) stated that they did not have the appropriate information on support services or resources to facilitate such conversations, differing by occupation group; 7 (11%) social workers, 34 (44%) medical specialists, 18 (25%) nurses, and 14 (27%) of other occupations. Hindrances to discussing financial concerns were insufficient resources or support systems to refer to, followed by lack of time in a typical consultation. CONCLUSION: Health professionals in cancer care commonly address the financial concerns of their patients but attitudes differed across occupations about their role, and frustrations were raised about available solutions. Resources supporting financial-related discussions for all health professionals are urgently needed to advance action in this field.

Clinical Management of Financial Toxicity-Identifying Opportunities through Experiential Insights of Cancer Survivors, Caregivers, and Social Workers.

Perspectives of cancer survivors, caregivers, and social workers as key stakeholders on the clinical management of financial toxicity (FT) are critical to identify opportunities for better FT management. Semi-structured interviews (cancer survivors, caregivers) and a focus group (social workers) were undertaken using purposive sampling at a quaternary public hospital in Australia. People with any cancer diagnosis attending the hospital were eligible. Data were analysed using inductive-deductive content analysis techniques. Twenty-two stakeholders (n = 10 cancer survivors of mixed-cancer types, n = 5 caregivers, and n = 7 social workers) participated. Key findings included: (i) genuine concern for FT of cancer survivors and caregivers shown through practical support by health care and social workers; (ii) need for clarity of role and services; (iii) importance of timely information flow; and (iv) proactive navigation as a priority. While cancer survivors and caregivers received financial assistance and support from the hospital, the lack of synchronised, shared understanding of roles and services in relation to finance between cancer survivors, caregivers, and health professionals undermined the effectiveness and consistency of these services. A proactive approach to anticipate cancer survivors' and caregivers' needs is recommended. Future research may develop and evaluate initiatives to manage cancer survivors and families FT experiences and outcomes.

Unmet supportive care needs of people with advanced cancer and their caregivers: A systematic scoping review.

Examining and addressing unmet care needs is integral to improving the provision and quality of cancer services. This review explored the prevalence of unmet supportive care needs, and factors associated with unmet need, in adults with advanced cancers (solid and hematological malignancies) and their caregivers. Electronic databases (PubMed, CINAHL, EMBASE) were searched, producing 85 papers representing 81 included studies. People with advanced cancer reported the highest unmet needs in financial, health system and information, psychological, and physical and daily living domains, whereas caregivers reported the highest unmet needs in psychological, and patient care and support domains. Distress, depression, and anxiety were associated with higher unmet needs across all unmet need domains for people with advanced cancer and their caregivers. Substantial heterogeneity in study populations and methods was observed. Findings from this review can inform targeted strategies and interventions to address these unmet needs in people with advanced cancer.

Exploring the role of general practitioners in addressing financial toxicity in cancer patients.

PURPOSE: Financial toxicity (FT) describes financial distress or hardship as an outcome of cancer and its treatment. Minimising the impact of FT requires early assessment and intervention. General practice plays a significant role in the support of a person with cancer and may have an important role in the management of FT. The purpose of this study was to understand perspectives of general practitioners (GP) on addressing FT in the primary care setting, which may then help inform strategies to further support collaborative efforts to address FT. METHODS: A qualitative interpretive approach was utilised for this study. GPs were recruited through a GP conference and other professional networks using purposive, snowballing sampling techniques. Data collection continued until sufficient rich data had been obtained. Interviews were recorded and transcribed verbatim. The data were analysed using inductive analysis techniques. RESULTS: Twenty (n = 20) GPs participated in semi-structured in-depth telephone interviews. GPs identified that their role positions them well to provide some FT support, but there are limitations. Perceptions and philosophies about cancer management were drivers of referrals and financial conversations. Priorities for care of FT by GPs included improved cost information provision and accessible support. CONCLUSION: GPs can play an important role in helping to address FT associated with cancer and its treatments if supported with the right information.

Out-of-pocket medical expenses compared across five years for patients with one of five common cancers in Australia.

BACKGROUND: Patient medical out-of-pocket expenses are thought to be rising worldwide yet data describing trends over time is scant. We evaluated trends of out-of-pocket expenses for patients in Australia with one of five major cancers in the first-year after diagnosis. METHODS: Participants from the QSKIN Sun and Health prospective cohort Study with a histologically confirmed breast, colorectal, lung, melanoma, or prostate cancer diagnosed between 2011 and 2015 were included (n = 1965). Medicare claims data on out-of-pocket expenses were analysed using a two-part model adjusted for year of diagnosis, health insurance status, age and education level. Fisher price and quantity indexes were also calculated to assess prices and volumes separately. RESULTS: On average, patients with cancer diagnosed in 2015 spent 70% more out-of-pocket on direct medical expenses than those diagnosed in 2011. Out-of-pocket expenses increased significantly for patients with breast cancer (mean AU$2513 in 2011 to AU$6802 in 2015). Out-of-pocket expenses were higher overall for individuals with private health insurance. For prostate cancer, expenses increased for those without private health insurance over time (mean AU$1586 in 2011 to AU$4748 in 2014) and remained stable for those with private health insurance (AU$4397 in 2011 to AU$5623 in 2015). There were progressive increases in prices and quantities of medical services for patients with melanoma, breast and lung cancer. For all cancers, prices increased for medicines and doctor attendances but fluctuated for other medical services. CONCLUSION: Out-of-pocket expenses for patients with cancer have increased substantially over time. Such increases were more pronounced for women with breast cancer and those without private health insurance. Increased out-of-pocket expenses arose from both higher prices and higher volumes of health services but differ by cancer type. Further efforts to monitor patient out-of-pocket costs and prevent health inequities are required.

Effect of infusion set replacement intervals on catheter-related bloodstream infections (RSVP): a randomised, controlled, equivalence (central venous access device)-non-inferiority (peripheral arterial catheter) trial.

BACKGROUND: The optimal duration of infusion set use to prevent life-threatening catheter-related bloodstream infection (CRBSI) is unclear. We aimed to compare the effectiveness and costs of 7-day (intervention) versus 4-day (control) infusion set replacement to prevent CRBSI in patients with central venous access devices (tunnelled cuffed, non-tunnelled, peripherally inserted, and totally implanted) and peripheral arterial catheters. METHODS: We did a randomised, controlled, assessor-masked trial at ten Australian hospitals. Our hypothesis was CRBSI equivalence for central venous access devices and non-inferiority for peripheral arterial catheters (both 2% margin). Adults and children with expected greater than 24 h central venous access device-peripheral arterial catheter use were randomly assigned (1:1; stratified by hospital, catheter type, and intensive care unit or ward) by a centralised, web-based service (concealed before allocation) to infusion set replacement every 7 days, or 4 days. This included crystalloids, non-lipid parenteral nutrition, and medication infusions. Patients and clinicians were not masked, but the primary outcome (CRBSI) was adjudicated by masked infectious diseases physicians. The analysis was modified intention to treat (mITT). This study is registered with the Australian New Zealand Clinical Trials Registry ACTRN12610000505000 and is complete. FINDINGS: Between May 30, 2011, and Dec, 9, 2016, from 6007 patients assessed, we assigned 2944 patients to 7-day (n=1463) or 4-day (n=1481) infusion set replacement, with 2941 in the mITT analysis. For central venous access devices, 20 (1·78%) of 1124 patients (7-day group) and 16 (1·46%) of 1097 patients (4-day group) had CRBSI (absolute risk difference [ARD] 0·32%, 95% CI -0·73 to 1·37). For peripheral arterial catheters, one (0·28%) of 357 patients in the 7-day group and none of 363 patients in the 4-day group had CRBSI (ARD 0·28%, -0·27% to 0·83%). There were no treatment-related adverse events. INTERPRETATION: Infusion set use can be safely extended to 7 days with resultant cost and workload reductions. FUNDING: Australian National Health and Medical Research Council.

Identifying a cut-off score for the COST measure to indicate high financial toxicity and low quality of life among cancer patients.

PURPOSE: To identify a cut-off score for the COmprehensive Score for financial Toxicity (COST) to predict a clinical implication of a high level of financial toxicity (FT). METHODS: A total of 640 cancer patients were recruited from three regional hospitals in Hong Kong. They completed a questionnaire comprising the COST measure and the Functional Assessment of Cancer Therapy - General (FACT-G) instrument. The cut-off score for the COST that predicts the lowest quartile of the FACT-G total score was identified by receiver operating characteristic (ROC) analysis. The sample was then stratified by this cut-off score, and characteristics were compared using Fisher's exact, chi-squared or independent sample t-test. RESULTS: The mean scores were 20.1 ± 8.8 for the COST and 71.6 ± 15.5 for the FACT-G. The ROC analysis suggested that the cut-off of 17.5 yielded an acceptable sensitivity and specificity. Characteristics of patients with a higher level of FT included being younger, having a monthly household income of < 10,000 HKD (approximately 1290 USD), being more likely not employed, having stage IV cancer and receiving targeted and/or immunotherapy. In terms of financial support, a higher proportion of these patients had discussed financial issues with health care professionals and had received financial assistance. In addition, fewer of them were covered by private health insurance. CONCLUSION: Our findings suggest a cut-off for the COST that can be used to screen for FT in clinical settings. In addition, while a considerable proportion of high-FT patients received targeted therapy, they often received financial assistance. There is a gap between financial hardship and assistance that warrants attention.

Translation and validation of the Traditional Chinese version of the COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (Version 2).

BACKGROUND: Cancer patients often experience severe financial distress due to the high cost of their treatment, and strategies are needed to objectively measure this financial distress. The COmprehensive Score for financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT) is one instrument used to measure such financial distress. This study aimed to translate the COST-FACIT (Version 2) [COST-FACIT-v2] instrument into traditional Chinese (COST-FACIT-v2 [TC]) and evaluate its psychometric properties. METHODS: The Functional Assessment of Chronic Illness Therapy (FACIT) translation method was adopted. The translated version was reviewed by an expert panel and by 20 cancer patients for content validity and face validity, respectively, and 640 cancer patients, recruited from three oncology departments, completed the translated scale. Its reliability was evaluated in terms of internal consistency and test-retest reliability. Confirmatory factor analysis has been used to evaluate the one- and two-factor structures of the instrument reported in the literature. The convergent validity was examined by the correlation with health-related quality of life (HRQoL) and psychological distress. Known-group validity was examined by the difference in the COST-FACIT-v2 (TC) total mean score between groups with different income levels and frequency of health care service use. RESULTS: The COST-FACIT-v2 (TC) showed good content and face validity and demonstrated high internal consistency (Cronbach's alpha, 0.86) and acceptable test-retest reliability (intraclass correlation coefficient, 0.71). Confirmatory factor analysis showed that the one- and two-factor structures of the instrument that have been reported in the literature could not be satisfactorily fitted to the data. Psychological distress correlated significantly with the COST-FACIT-v2 (TC) score (r = 0.47; p < 0.001). HRQOL showed a weak to moderate negative correlation with the COST-FACIT-v2 (TC) score (r = - 0.23 to - 0.46; p < 0.001). Significant differences were seen among the COST-FACIT-v2 (TC) scores obtained in groups of different income level and frequency of health care service use. CONCLUSIONS: The COST-FACIT-v2 (TC) showed some desirable psychometric properties to support its validity and reliability for assessing cancer patients' level of financial toxicity.

Harnessing the power of clinician judgement. Identifying risk of deteriorating and dying in people with a haematological malignancy: A Delphi study.

AIM: To provide expert consensus on the clinical indicators that signal a person with a haematological malignancy is at high risk of deteriorating and dying. BACKGROUND: Identification of people who are at risk of deteriorating and dying is essential to facilitate patient autonomy, appropriate treatment decisions, and effective end-of-life care. DESIGN: A three-step modified Delphi approach. METHODS: The study was conducted over 6 months (September 2015-March 2016) to gather opinion from an international panel of experts (N = 27) on the clinical indicators that signal a person with a haematological malignancy is at high risk of deteriorating and dying. The first round was informed by a systematic review of prognostic factors present in the final months of life for people with a haematological malignancy. Consensus was achieved if 70% of responses fell within two points on a seven-point Likert-type scale. FINDINGS: Consensus was achieved on the following 11 clinical indicators: (a) advancing age; (b) declining performances status; (c) presence of co-morbidities; (d) disease status; (e) persistent infections (bacterial and viral); (f) fungal infections; (g) severe graft versus host disease; (h) requiring high care; (i) signs of frailty; (j) treatment limitations; and (k) anorexia and/or weight loss. Consensus was also achieved on associated themes and statements for each indicator. CONCLUSION: The findings of this study indicate that subjective clinician-assessed indicators that are contextually relevant to the nature of haematological malignancies are markers of risk. This study has provided valuable preliminary findings on the topic and will inform future research.

Insertion site assessment of peripherally inserted central catheters: Inter-observer agreement between nurses and inpatients.

INTRODUCTION: Many patients are discharged from hospital with a peripherally inserted central catheter in place. Monitoring the peripherally inserted central catheter insertion site for clinical and research purposes is important for identifying complications, but the extent to which patients can reliably report the condition of their catheter insertion site is uncertain. The aim of this study was to assess the inter-observer agreement between nurses and patients when assessing a peripherally inserted central catheter site. METHODS: The study was based on inpatients who were enrolled in a single-centre, randomised controlled trial comparing four different dressing and securement devices for peripherally inserted central catheter sites. A seven-item peripherally inserted central catheter site assessment tool, containing questions about the condition of the dressing and the insertion site, was developed. Assessment was conducted once by the research nurse and, within a few minutes, independently by the patient. Proportions of agreement and Cohen's kappa were calculated. RESULTS: In total, 73 patients agreed to participate. Overall, percentage agreement ranged from 83% to 100% (kappa = .65-.82). For important clinical signs (redness, swelling, ooze, pus and tracking), there were high levels of percentage agreement (99%-100%). CONCLUSION: The high level of agreement between nurse/patient pairs make the instrument useful for assessing peripherally inserted central catheter-associated signs of localised infection, allergic or irritant dermatitis or dressing dislodgement in a community setting.

Clinical and economic outcomes of nurse-led services in the ambulatory care setting: A systematic review.

BACKGROUND: With the increasing burden of chronic and age-related diseases, and the rapidly increasing number of patients receiving ambulatory or outpatient-based care, nurse-led services have been suggested as one solution to manage increasing demand on the health system as they aim to reduce waiting times, resources, and costs while maintaining patient safety and enhancing satisfaction. OBJECTIVES: The aims of this review were to assess the clinical effectiveness, economic outcomes and key implementation characteristics of nurse-led services in the ambulatory care setting. DESIGN: A systematic review was conducted using the standard Cochrane Collaboration methodology and was prepared in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. DATA SOURCES: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library, MEDLINE EBSCO, CINAHL EBSCO, and PsycINFO Ovid (from inception to April 2016). REVIEW METHODS: Data were extracted and appraisal undertaken. We included randomised controlled trials; quasi-randomised controlled trials; controlled and non-controlled before-and-after studies that compared the effects of nurse-led services in the ambulatory or community care setting with an alternative model of care or standard care. RESULTS: Twenty-five studies of 180,308 participants were included in this review. Of the 16 studies that measured and reported on health-related quality of life outcomes, the majority of studies (n = 13) reported equivocal outcomes; with three studies demonstrating superior outcomes and one demonstrating inferior outcomes in comparison with physician-led and standard care. Nurse-led care demonstrated either equivalent or better outcomes for a number of outcomes including symptom burden, self-management and behavioural outcomes, disease-specific indicators, satisfaction and perception of quality of life, and health service use. Benefits of nurse-led services remain inconclusive in terms of economic outcomes. CONCLUSIONS: Nurse-led care is a safe and feasible model of care for consideration across a number of ambulatory care settings. With appropriate training and support provided, nurse-led care is able to produce at least equivocal outcomes or at times better outcomes in terms of health-related quality of life compared to physician-led care or standard care for managing chronic conditions. There is a lack of high quality economic evaluations for nurse-led services, which is essential for guiding the decision making of health policy makers. Key factors such as education and qualification of the nurse; self-management support; resources available for the nurse; prescribing capabilities; and evaluation using appropriate outcome should be carefully considered for future planning of nurse-led services.

Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: the PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial.

INTRODUCTION: Around 30% of peripherally inserted central catheters (PICCs) fail from vascular, infectious or mechanical complications. Patients with cancer are at highest risk, and this increases morbidity, mortality and costs. Effective PICC dressing and securement may prevent PICC failure; however, no large randomised controlled trial (RCT) has compared alternative approaches. We designed this RCT to assess the clinical and cost-effectiveness of dressing and securements to prevent PICC failure. METHODS AND ANALYSIS: Pragmatic, multicentre, 2×2 factorial, superiority RCT of (1) dressings (chlorhexidine gluconate disc (CHG) vs no disc) and (2) securements (integrated securement dressing (ISD) vs securement device (SED)). A qualitative evaluation using a knowledge translation framework is included. Recruitment of 1240 patients will occur over 3 years with allocation concealment until randomisation by a centralised service. For the dressing hypothesis, we hypothesise CHG discs will reduce catheter-associated bloodstream infection (CABSI) compared with no CHG disc. For the securement hypothesis, we hypothesise that ISD will reduce composite PICC failure (infection (CABSI/local infection), occlusion, dislodgement or thrombosis), compared with SED. SECONDARY OUTCOMES: types of PICC failure; safety; costs; dressing/securement failure; dwell time; microbial colonisation; reversible PICC complications and consumer acceptability. Relative incidence rates of CABSI and PICC failure/100 devices and/1000 PICC days (with 95% CIs) will summarise treatment impact. Kaplan-Meier survival curves (and log rank Mantel-Haenszel test) will compare outcomes over time. Secondary end points will be compared between groups using parametric/non-parametric techniques; p values <0.05 will be considered to be statistically significant. ETHICS AND DISSEMINATION: Ethical approval from Queensland Health (HREC/15/QRCH/241) and Griffith University (Ref. No. 2016/063). Results will be published. TRIAL REGISTRATION: Trial registration number is: ACTRN12616000315415.