A Discourse of Deviance: Blame, Shame, Stigma and the Social Construction of Head and Neck Cancer.

Cancer of the head and neck is a confronting condition, as the disease and its treatments alter the appearance and function of body organs associated with physical appearance and identity. Many of the risk factors for head and neck cancers, including tobacco, alcohol, and human papilloma virus, can also have significant negative social and moral permutations. Language and action (discourse) plays an important role in constructing disease and illness and shape the way it is managed, both institutionally and socially. This research used a critical constructionist lens to investigate how the common discourses surrounding head and neck cancer are constructed within the healthcare context and how this influences patients and healthcare professionals' responses to the illness. Data were collected through semi-structured interviews, field noting, journaling and literature reviews. Analysis was guided by a three-dimensional approach to critical discourse analysis that investigated text, discursive practices, and social context. The overarching finding was that deviance dominates the common discourse and shapes head and neck cancer and responses to it. Deviance is channelled through metaphors, adjectives, descriptors, and collective nouns and is made overt through labelling, avoidance, blaming, shame, and categorization. Discourse is contextualized by a sociocultural understanding that when someone deviates from what is perceived as normal, they are devalued. Open dialogue and reflection on head and neck cancer discourse could enable better understanding of how people experience their condition and inform more supportive responses.

Economic evaluation of exercise interventions for individuals with cancer: A systematic review.

While there is good evidence that exercise is an effective adjunct therapy to cancer care, little is known about its value for money. The aim of this systematic review is to explore the available evidence pertaining to the cost-effectiveness of exercise interventions following cancer. A search of eight online databases (CINAHL, the Cochrane Library (NHSEED), Econlit, Embase, PsycInfo, PubMed, Scopus, Web of science) was first conducted on 26 March 2021 and updated on 8 March 2022. Only economic evaluations with results in the form of incremental cost-effectiveness ratio (ICER) were included. The Consolidated Health Economics Evaluation Reporting Standards (CHEERS) was used to appraise the quality of reporting in the studies. The study protocol was registered in PROSPERO. Sixteen studies comprising seven (44%) cost-utility analyses (CUA), one (6%) cost-effectiveness analyses (CEA) and eight (50%) combined CUA and CEA were identified. These studies explored exercise in five cancer types (breast, colon, lung, prostate, and blood), with half (50%) in breast cancer. Seven studies (44%) adopted societal perspectives. Exercise interventions were found to be cost-effective in five of ten (50%) trial-based economic evaluations and in five of the six (83%) model-based economic evaluations. Most exercise interventions included were supervised, while close supervision and individualized exercise sessions incurred higher costs. Exercise interventions in cancer care are cost-effective for various cancer types despite considerable heterogeneity in exercise delivery and the type of analysis used for economic evaluation. There is clear value in using decision-analytic modelling to account for the long-term benefits of exercise in cancer care.

Cost-utility analysis of a supervised exercise intervention for women with early-stage endometrial cancer.

PURPOSE: Cardiovascular disease (CVD) is the leading cause of death after treatment for endometrial cancer (EC). There is clinical evidence that exercise significantly reduces the risks of CVD and cancer recurrence in this population; however, it is unclear whether there is value for money in integrating exercise into cancer recovery care for women treated for EC. This paper assesses the long-term cost-effectiveness of a 12-week supervised exercise intervention, as compared with standard care, for women diagnosed with early-stage EC. METHOD: A cost-utility analysis was conducted from the Australian health system perspective for a time horizon of 5 years. A Markov cohort model was designed with six mutually exclusive health states: (i) no CVD, (ii) post-stroke, (iii) post-coronary heart disease (CHD), (iv) post-heart failure, (v) post-cancer recurrence, and (vi) death. The model was populated using the best available evidence. Costs and quality-adjusted life years (QALYs) were discounted at 5% annual rate. Uncertainty in the results was explored using one-way and probabilistic sensitivity analyses (PSA). RESULT: The incremental cost of supervised exercise versus standard care was AUD $358, and the incremental QALY was 0.0789, resulting in an incremental cost-effectiveness ratio (ICER) of AUD $5184 per QALY gained. The likelihood that the supervised exercise intervention was cost-effective at a willingness-to-pay threshold of AUD $50,000 per QALY was 99.5%. CONCLUSION: This is the first economic evaluation of exercise after treatment for EC. The results suggest that exercise is cost-effective for Australian EC survivors. Given the compelling evidence, efforts could now focus on the implementation of exercise as part of cancer recovery care in Australia.

Controlling peripheral intravenous catheter failure by needleless connector design: A pilot randomised controlled trial.

AIM: To test the feasibility of a study protocol that compared the efficacy of neutral- and negative-pressure needleless connectors (NCs). DESIGN: A single-centre, parallel-group, pilot randomised control trial. METHODS: Our study compared neutral-(intervention) and negative-pressure (control) NCs among adult patients in an Australian hospital. The primary feasibility outcome was measured against predetermined criteria (e.g. eligibility, attrition). The primary efficacy outcome was all-cause peripheral intravenous catheter failure, analysed as time-to-event data. RESULTS: In total, 201 (100 control; 101 intervention) participants were enrolled between March 2020 and September 2020. All feasibility criteria were met except eligibility, which was lower (78%) than the 90% criterion. All-cause peripheral intravenous catheter failure was significantly higher in the intervention group (39%) compared to control (19%). CONCLUSION: With minor modifications to participant screening for eligibility, this randomised control trial is feasible for a large multicentre randomised control trial. The neutral NC was associated with an increased risk of peripheral intravenous catheter failure. IMPLICATIONS FOR THE PROFESSION AND/OR PATIENT CARE: There are several NC designs available, often identified by their mechanism of pressure (positive, negative and neutral). However, NCs can contribute to peripheral intravenous catheter failure. This is the first randomised controlled trial to compare neutral and negative NC designs. Negative pressure NCs had lower PIVC failure compared to neutral NCs, however the results might not be generalisable to other brands or treatment settings. Further high-quality research is needed to explore NC design. REPORTING METHOD: Study methods and results reported in adherence to the CONSORT Statement. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

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 ).

Sleep and health-related quality of life in women following a cancer diagnosis: results from the Women's Wellness after Cancer Program in Australia.

PURPOSE: Sleep disturbance after cancer treatment could compromise recovery. This paper examined the associations between post-treatment sleep problems and health-related quality of life (HRQoL), and the effectiveness of an e-enabled lifestyle intervention on sleep outcomes. METHODS: The Women's Wellness after Cancer Program (WWACP) was examined in a single blinded, multi-centre randomised controlled trial. Data were collected from 351 women (Mage = 53.2, SD = 8.8; intervention n = 175, control group n = 176) who had completed surgery, chemotherapy and/or radiotherapy for breast, gynaecological or blood cancers within the previous 24 months. Participants completed the Pittsburgh Sleep Quality Index (PSQI) at baseline (prior to intervention randomisation), and at 12 and 24 weeks later. Sociodemographic information, menopausal symptoms (Greene Climacteric Scale) and HRQoL (36-Item Short Form Health Survey; SF-36) were also collected. Linear panel regression was used to examine the association between sleep variables and SF36 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. A difference-in-difference regression model approach was used to examine the intervention effect on the sleep outcomes. RESULTS: After adjustment for potential confounders, the sleep variables (except sleep duration) significantly predicted physical, but not mental, HRQoL. There was no statistically significant effect of the intervention on sleep outcomes at 12 or 24 weeks. CONCLUSION: Women who have completed treatment for cancer experience sleep problems that are associated with decreased physical HRQoL. Improving sleep through targeted interventions should improve their physical HRQoL. Improved targeting of the sleep components of the WWACP should be explored.

Transdisciplinary allied health assessment for patients with stroke: a pre-/post- mixed methods study protocol.

BACKGROUND: Transdisciplinary approaches can streamline processes and build workforce capacity by blurring traditional responsibilities and integrating aspects of care. Emerging evidence shows transdisciplinary approaches can improve time-efficiency, quality of care and cost-effectiveness across various healthcare settings, however no empirical study is based on an acute stroke unit. METHODS: The SPIRIT checklist was used to guide the content of the research protocol. The study is a pragmatic pre-/post- mixed methods four-phase study with a 3-month follow up, based at the Mater Hospital Brisbane. Participants experiencing stroke symptoms will be recruited as they are admitted to the acute stroke unit. Patients presenting with mild stroke symptoms or Transient Ischaemic Attack will be allocated to Phase 1 (baseline) or Phase 2 (implementation), while patients presenting with moderate to severe stroke symptoms will be allocated to Phase 3 (baseline) or Phase 4 (implementation). Participants in baseline Phases 1 and 3 will receive standard allied health assessment, while participants in implementation Phases 2 and 4 will receive the novel transdisciplinary assessment. For the primary aim, allied health professionals will time their assessments to evaluate time taken to administer a novel transdisciplinary assessment, compared to usual discipline-specific assessments. Non-inferiority of the novel transdisciplinary assessment will also be explored in terms of patient safety, compliance to national standards, use of the assessment, and stakeholder perceptions. A retrospective medical record audit, staff focus group, patient/staff surveys, and patient phone interviews at 3-months will be completed. Quantitative results will be estimated using general linear and logistic regression models in Stata 15.1. Qualitative results will be analysed using frequency counts and NVivo software. An economic evaluation will be performed using three scopes including the allied health assessment, hospital admission, and patient outcomes at 3-months. DISCUSSION: When designing the study, pragmatic factors related to staff willingness to be involved, patient safety, and existing clinical pathways/processes were considered. To address those factors, a co-design approach was taken, resulting in staff buy-in, clinically relevant outcome measures, and the pre-/post- four-phase study design. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12621000380897. Registered 06 April 2021 - retrospectively registered, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=381339&isReview=true.

Developing a postgraduate professional education framework for emergency nursing: a co-design approach.

BACKGROUND: Hospital and university service providers invest significant but separate resources into preparing registered nurses to work in the emergency department setting. This results in the duplication of both curricula and resource investment in the health and higher education sectors. This paper describes an evidence-based co-designed study with clinical-academic stakeholders from hospital and university settings. METHODS: The study was informed by evidence-based co-design, using emergency nursing as an exemplar. Eighteen hours of co-design workshops were completed with 21 key clinical-academic stakeholders from hospital and university settings. RESULTS: Outcomes were matrices synchronising professional and regulatory imperatives of postgraduate nursing coursework; mutually-shaped curriculum content, teaching approaches and assessment strategies relevant for postgraduate education; a new University-Industry Academic Integration Framework; five agreed guiding principles of postgraduate curriculum development for university-industry curriculum co-design; and a Graduate Certificate of Emergency Nursing curriculum exemplar. CONCLUSION: Industry-academic service provider co-design can increase the relevance of postgraduate specialist courses in nursing, strengthening the nexus between both entities to advance learning and employability. The study developed strategies and exemplars for future use in any mutually determined academic-industry education partnership.

Catheter-related thrombosis incidence and risk factors in adult cancer patients with central venous access devices.

BACKGROUND: Central venous access devices (CVAD) are commonly employed in the management of cancer patients. While having several benefits they are associated with significant risks. AIM: To review the incidence and risk factors for catheter-related thrombosis (CRT) in cancer patients with a CVAD. METHODS: We performed a prospective observational cohort study of adult patients with cancer requiring a CVAD between 1 January 2004 and 29 June 2016. The rate of, and risk factors for the development of, symptomatic CRT were evaluated. RESULTS: A total of 4920 central lines was inserted into 3130 patients. The incidence of CRT was 3.6%. CRT developed a median of 12 days following line insertion. Peripherally inserted central catheters (PICC) were associated with the highest rates of CRT (hazards ratio (HR) 22.2, 95% confidence interval (CI) 2.9-170.6). Older age groups developed CRT at lower rates (HR 0.57; 95% CI 0.39-0.84 for age 50-61 years, and HR 0.63; 95% CI 0.45-0.89 for age >61 years) compared to age <50 years. Increased CRT was seen in patients with prior CRT (HR 1.81; 95% CI 1.19-2.77). There was a trend to more CRT events with a Khorana tumour score of 1 compared to those with a score of 0 (HR 1.37, 95% CI 1.00-1.88). Hodgkin lymphoma, germ cell and oesophagus cancers had the highest CRT rates. Side of insertion was not associated with thrombosis risk (HR 0.77; 95% CI 0.57-1.05; P = 0.10). CONCLUSIONS: Age <50 years, PICC lines and prior CRT were associated with highest CRT rate. Cancer subtype and insertion side were not predictive of thrombosis.

The ENHANCES study: a randomised controlled trial of a nurse-led survivorship intervention for patients treated for head and neck cancer.

PURPOSE: A randomised controlled trial was conducted to evaluate the effectiveness of a nurse-delivered Head and Neck Cancer Survivor Self-Management Care Plan (HNCP) for patients who had completed treatment for head and neck cancer (HNC). METHODS: Ten oncology nurses were trained to deliver the HNCP. The HNCP consisted of one face-to-face hour-long meeting in which the patient's treatment was recorded, as were contact details of health professionals involved in their care and follow-up schedules. Patients were guided to nominate up to three goals for their future well-being and assisted to devise an action plan to achieve these. The HNCP was given to the patient and a copy was forwarded to their primary care physician. One hundred and nine patients were randomised after definitive curative intent treatment, 36 to HNCP, 36 to receive information about survivorship, and 37 to usual care. The primary outcome, analysed by intention-to-treat, was change in quality of life measured by the FACT-H&N from baseline to 6-month follow-up. RESULTS: Quality of life of all groups decreased at 3 months but was close to baseline at 6 months. Compared with the usual care group, the only statistically significant mean difference at 6 months was for the information group on the physical well-being domain (mean difference 0.4, 95% - 1.8, 2.6, p < 0.05). CONCLUSIONS: A single-session nurse-delivered intervention is insufficient to improve the quality of life in HNC survivors compared with usual care. Provision of detailed written information about HNC survivorship is associated with improved physical well-being. TRIAL REGISTRATION: ACTRN12613000542796.

Efficacy of Exercise Interventions in Patients With Advanced Cancer: A Systematic Review.

OBJECTIVE: To critically analyze the literature surrounding the efficacy of exercise interventions in patients with advanced cancer. DATA SOURCES: A literature search was undertaken of health and medical electronic databases (PubMED, Medline, CINAHL, Embase, PEDRO, Web of Science, Scopus) until March 1, 2017. STUDY SELECTION: Studies were included if they were published in the English language and met the following criteria: structured exercise as the primary intervention, ≥80% study participants diagnosed with advanced cancer that is unlikely to be cured; reported outcomes concerning physical function, quality of life, fatigue, body composition, psychosocial function, sleep quality pain, and/or survival. DATA EXTRACTION: After title and abstract screening, 68 articles were eligible for full-text review, with a total of 25 studies (n=1188; 16 controlled trials, 9 noncontrolled trials) included in the quantitative synthesis. Two reviewers assessed methodological quality using the Cochrane Risk of Bias Tool for controlled trials and a modified Newcastle-Ottawa Scale for noncontrolled trials. DATA SYNTHESIS: Aerobic exercise was used in 6 studies, resistance training in 3 studies, and combination training (aerobic and resistance) in 15 studies. Significant between- and within-group improvements were reported with exercise in ≥50% of studies assessing physical function (83%), quality of life (55%), fatigue (50%), body composition (56%), psychosocial function (56%), and sleep quality (100%). Improvement within or between groups in pain after exercise was only observed in 2 studies (25%), whereas survival was unaffected in any study. CONCLUSIONS: Most studies reported significant between- and/or within-group improvements in physical function, quality of life, fatigue, body composition, psychosocial function, and sleep quality in patients with advanced cancer, although the effects on pain and survival rates are unclear. Exercise appears to be an effective adjunct therapy in the advanced cancer context, although targeted studies are required to determine the optimal exercise dose to enhance outcomes for specific cancer diagnoses.

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.

Ginger-Mechanism of action in chemotherapy-induced nausea and vomiting: A review.

Despite advances in antiemetic therapy, chemotherapy-induced nausea and vomiting (CINV) still poses a significant burden to patients undergoing chemotherapy. Nausea, in particular, is still highly prevalent in this population. Ginger has been traditionally used as a folk remedy for gastrointestinal complaints and has been suggested as a viable adjuvant treatment for nausea and vomiting in the cancer context. Substantial research has revealed ginger to possess properties that could exert multiple beneficial effects on chemotherapy patients who experience nausea and vomiting. Bioactive compounds within the rhizome of ginger, particularly the gingerol and shogaol class of compounds, interact with several pathways that are directly implicated in CINV in addition to pathways that could play secondary roles by exacerbating symptoms. These properties include 5-HT3, substance P, and acetylcholine receptor antagonism; antiinflammatory properties; and modulation of cellular redox signaling, vasopressin release, gastrointestinal motility, and gastric emptying rate. This review outlines these proposed mechanisms by discussing the results of clinical, in vitro, and animal studies both within the chemotherapy context and in other relevant fields. The evidence presented in this review indicates that ginger possesses multiple properties that could be beneficial in reducing CINV.

Safety and feasibility of exercise interventions in patients with advanced cancer: a systematic review.

GOALS OF WORK: The beneficial effects of exercise in cancer patients are reasonably well-established, although research in this field has predominantly investigated cancer patients in the earlier stages of disease. However, the most recent evidence surrounding exercise interventions in advanced cancer populations has yet to be systematically evaluated. This review critically analyses the safety and feasibility of exercise interventions in patients with advanced cancer. METHODS: All randomised, non-randomised and prospective observational trials of exercise training interventions in patients with advanced cancer were included. 'Safety' was defined as the number and severity of reported adverse events during exercise training. 'Feasibility' was determined by participant adherence, attendance and/or study completion rates. RESULTS: A total of 25 studies involving 1088 patients were included: 16 randomised controlled and nine prospective observational cohort trials. Seven studies included advanced lung cancer patients exclusively, while eight involved patients with various cancer diagnoses. Aerobic exercise was investigated in five studies, resistance training in two studies and combination training (aerobic and resistance) in 14 studies. Six minor adverse events were reported due to exercise. All of these were musculoskeletal in nature, resulting in two participants' withdrawal from the study. Exercise adherence ranged from 65 to 89% but was only described in nine studies. Attendance at each exercise session was described in a further nine studies, ranging from 59 to 100%. CONCLUSIONS: Implementation of exercise interventions appears to be safe and feasible in advanced cancer clinical practice, although targeted studies are required to determine the optimal exercise dose for specific cancer diagnoses.

The prevention, detection and management of cancer treatment-induced cardiotoxicity: a meta-review.

BACKGROUND: The benefits associated with some cancer treatments do not come without risk. A serious side effect of some common cancer treatments is cardiotoxicity. Increased recognition of the public health implications of cancer treatment-induced cardiotoxicity has resulted in a proliferation of systematic reviews in this field to guide practice. Quality appraisal of these reviews is likely to limit the influence of biased conclusions from systematic reviews that have used poor methodology related to clinical decision-making. The aim of this meta-review is to appraise and synthesise evidence from only high quality systematic reviews focused on the prevention, detection or management of cancer treatment-induced cardiotoxicity. METHODS: Using Cochrane methodology, we searched databases, citations and hand-searched bibliographies. Two reviewers independently appraised reviews and extracted findings. A total of 18 high quality systematic reviews were subsequently analysed, 67 % (n = 12) of these comprised meta-analyses. RESULTS: One systematic review concluded that there is insufficient evidence regarding the utility of cardiac biomarkers for the detection of cardiotoxicity. The following strategies might reduce the risk of cardiotoxicity: 1) The concomitant administration of dexrazoxane with anthracylines; 2) The avoidance of anthracyclines where possible; 3) The continuous administration of anthracyclines (>6 h) rather than bolus dosing; and 4) The administration of anthracycline derivatives such as epirubicin or liposomal-encapsulated doxorubicin instead of doxorubicin. In terms of management, one review focused on medical interventions for treating anthracycline-induced cardiotoxicity during or after treatment of childhood cancer. Neither intervention (enalapril and phosphocreatine) was associated with statistically significant improvement in ejection fraction or mortality. CONCLUSION: This review highlights the lack of high level evidence to guide clinical decision-making with respect to the detection and management of cancer treatment-associated cardiotoxicity. There is more evidence with respect to the prevention of this adverse effect of cancer treatment. This evidence, however, only applies to anthracycline-based chemotherapy in a predominantly adult population. There is no high-level evidence to guide clinical decision-making regarding the prevention, detection or management of radiation-induced cardiotoxicity.

Cryotherapy for docetaxel-induced hand and nail toxicity: randomised control trial.

PURPOSE: This study investigated the efficacy and safety of cryotherapy, in the form of frozen gel gloves, in relation to docetaxel-induced hand and fingernail toxicities. PATIENTS AND METHODS: After piloting with 21 patients, a consecutive series sample of patients (n=53) prescribed docetaxel every 3 weeks, for a minimum of three cycles, was enrolled in this randomised control trial. Participants acted as their own control, with the frozen gel glove worn on one randomised hand for 15 min prior to infusion, for the duration of the infusion, and for 15 min of after completion of treatment. Hand and nail toxicities were evaluated by two blinded assessors according to CTCAE.v4 criteria. To assess the potential for cross-infection of multi-use gloves, microbial culture and sensitivity swabs were taken of each glove at every tenth use. RESULTS: Of the 53 participants enrolled in the main study, 21 provided evaluable data. There was a 60 % withdrawal rate due to patient discomfort with the intervention. The mean incidence and severity of toxicities in all evaluable cycles in control and intervention hands respectively were erythroderma grade 1 (5/5 %), nail discolouration grade 1 (81/67 %), nail loss grade 1 (19/19 %) and nail ridging grade 1 (57/57 %). No significant differences were determined between hand conditions in terms of time to event, nor in terms of toxicity in gloved and non-gloved hands. CONCLUSION: While cryotherapy in the form of frozen gloves for the cutaneous toxicities associated with docetaxel is safe, its limited efficacy, patient discomfort and some logistical issues preclude its use in our clinical setting.

Can ginger ameliorate chemotherapy-induced nausea? Protocol of a randomized double blind, placebo-controlled trial.

BACKGROUND: Preliminary research shows ginger may be an effective adjuvant treatment for chemotherapy-induced nausea and vomiting but significant limitations need to be addressed before recommendations for clinical practice can be made. METHODS/DESIGN: In a double-blinded randomised-controlled trial, chemotherapy-naïve patients will be randomly allocated to receive either 1.2 g of a standardised ginger extract or placebo per day. The study medication will be administrated as an adjuvant treatment to standard anti-emetic therapy and will be divided into four capsules per day, to be consumed approximately every 4 hours (300 mg per capsule administered q.i.d) for five days during the first three cycles of chemotherapy. Acute, delayed, and anticipatory symptoms of nausea and vomiting will be assessed over this time frame using a valid and reliable questionnaire, with nausea symptoms being the primary outcome. Quality of life, nutritional status, adverse effects, patient adherence, cancer-related fatigue, and CINV-specific prognostic factors will also be assessed. DISCUSSION: Previous trials in this area have noted limitations. These include the inconsistent use of standardized ginger formulations and valid questionnaires, lack of control for anticipatory nausea and prognostic factors that may influence individual CINV response, and the use of suboptimal dosing regimens. This trial is the first to address these issues by incorporating multiple unique additions to the study design including controlling for CINV-specific prognostic factors by recruiting only chemotherapy-naïve patients, implementing a dosing schedule consistent with the pharmacokinetics of oral ginger supplements, and independently analysing ginger supplements before and after recruitment to ensure potency. Our trial will also be the first to assess the effect of ginger supplementation on cancer-related fatigue and nutritional status. Chemotherapy-induced nausea and vomiting are distressing symptoms experienced by oncology patients; this trial will address the significant limitations within the current literature and in doing so, will investigate the effect of ginger supplementation as an adjuvant treatment in modulating nausea and vomiting symptoms. TRIAL REGISTRATION: ANZCTR.org.au Identifier: ACTRN12613000120774.

Does an allied health transdisciplinary stroke assessment save time, improve quality of care, and save costs? Results of a pre-/post- clinical study.

PURPOSE: Demand for stroke services is increasing. To save time and costs, stroke care could be reorganised using a transdisciplinary assessment model embracing overlapping allied health professional skills. The study compares transdisciplinary assessment to discipline-specific allied health assessment on an acute stroke unit, by evaluating assessment time, quality of care, and cost implications. METHOD: The pre-/post- clinical study used non-randomised groups and 3-month follow-up after hospital admission. Patients with confirmed/suspected stroke received usual discipline-specific allied health assessment (pre-implementation phase) or the novel transdisciplinary assessment (post-implementation phase). Staff/student assessment times (primary outcome) and medical record data (secondary outcomes) were collected. Time differences were estimated using multivariable linear regression controlling for confounding factors. Cost minimisation and sensitivity analyses estimated change in hospital resource use. FINDINGS: When the transdisciplinary assessment was used (N = 116), compared to usual assessment (N = 63), the average time saving was 37.6 min (95% CI -47.5, -27.7; p < 0.001) for staff and 62.2 min (95% CI -74.1, -50.3; p < 0.001) for students. The median number of allied health occasions of service reduced from 8 (interquartile range 4-23) to 5 (interquartile range 3-10; p = 0.011). There were no statistically significant or clinically important changes in patient safety, outcomes or stroke guideline adherence. Improved efficiency was associated with an estimated cost saving of $379.45 per patient (probabilistic 95% CI -487.15, -271.48). DISCUSSION AND CONCLUSION: Transdisciplinary stroke assessment has potential for reorganising allied health services to save assessment time and reduce healthcare costs. The transdisciplinary stroke assessment could be considered for implementation in other stroke services.

Effect of a Standardized Ginger Root Powder Regimen on Chemotherapy-Induced Nausea and Vomiting: A Multicenter, Double-Blind, Placebo-Controlled Randomized Trial.

BACKGROUND: There is substantial interest in the role of ginger as an adjuvant therapy for chemotherapy-induced nausea and vomiting (CINV). However, available evidence lacks robust methodology. OBJECTIVE: To assess the effect of adjuvant ginger compared with placebo on chemotherapy-induced nausea-related quality of life (QoL) and CINV-related outcomes. DESIGN: A parallel, double-blind, placebo-controlled randomized trial with 1:1 allocation was conducted. PARTICIPANTS/SETTING: One hundred three chemotherapy-naïve adults scheduled to receive moderately to highly emetogenic chemotherapy at two hospitals in Australia were enrolled and analyzed. INTERVENTION: Four standardized ginger capsules (totaling 84 mg/day active gingerols/shogaols), or placebo, were administered commencing the day of chemotherapy and continuing for 5 days for chemotherapy cycles 1 through 3. MAIN OUTCOME MEASURES: The primary outcome was chemotherapy-induced nausea-related QoL. Secondary outcomes were vomiting- and CINV-related QoL; anticipatory, acute, and delayed nausea and vomiting; fatigue; nutritional status; depression and anxiety; health-related QoL; and adverse events. STATISTICAL ANALYSES PERFORMED: Intention-to-treat analysis was performed. Mixed analysis of variance with repeated measures determined differences between groups. The null hypothesis was no difference between groups. After applying a Bonferroni multiple testing correction, evidence against the null hypothesis was considered at P= 0.003. RESULTS: One hundred three participants (ginger: n = 52; placebo: n = 51) were enrolled and analyzed. There was clinically relevant evidence against the null hypothesis, favoring ginger, in change scores for nausea-related QoL (F[df] = 9.34[1,101]; P = 0.003; partial η2 = 0.09), overall CINV-related QoL (F[df] = 12.26[1,101]; P < 0.001; partial η2 = 0.11), delayed nausea severity (F[df] = 9.46[1,101]; P = 0.003; partial η2 = 0.09), and fatigue (F[df] = 10.11[1,101]; P = 0.002; partial η2 = 0.09). There was a clinically meaningful lower incidence of delayed nausea and vomiting in the ginger group at Cycle 2 (53% vs 75%; P = 0.020 and 4% vs 27%; P = 0.001, respectively) and Cycle 3 (49% vs 79%; P = 0.002 and 2% vs 23%; P = 0.001, respectively). There was a clinically meaningful lower incidence of malnutrition in the ginger group at Cycle 3 (18% vs. 41%; P = 0.032) and in change scores for Patient-Generated Subjective Global Assessment (F[df)] = 4.32[1,100]; P = 0.040; partial η2 = 0.04). Change scores between groups favored ginger for vomiting-related QoL and number of vomiting episodes; however, findings were not clinically meaningful. There was no effect of ginger on anticipatory or acute CINV, health-related QoL, anxiety, or depression. No serious adverse events were reported. CONCLUSIONS: Ginger supplementation was a safe adjuvant to antiemetic medications for CINV that enhanced QoL during chemotherapy treatment. Future trials are needed to examine dose-dependent responses to verify optimal dosing regimens.