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.

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.

Development and testing of a patient-reported experience measure for cancer: A cross-sectional survey.

AIM: To develop and psychometrically test the Patient-reported Experience Measure-Cancer (PREM-C), reflecting patients' perceptions of cancer care experiences according to the Institute of Medicine domains. DESIGN: A three-phase cross-sectional survey was conducted. METHODS: Development, reliability and validity testing of the PREM-C measure was undertaken. Data collection included three phases: firstly (development) between October and November, 2015; secondly (psychometric testing), May 2016-June, 2017, and finally, (revision and psychometric testing) May 2019-March 2020. RESULTS: The final PREM-C structure, created using the Institute of Medicine domains, was psychometrically sound with five factors identified in the Exploratory Factor Analysis, demonstrating internal reliability ranging from 0.8 to 0.9. Confirmatory Factor Analysis indicated the hypothesized model fitted well (Root mean square error of approximation = 0.076). External convergent and divergent validity was established with the PREM-C found to be moderately correlated with the Picker Patient Experience Questionnaire but weakly correlated with the WHOQoL-BREF. CONCLUSION: The development and testing of the PREM-C demonstrated good fit as a clinically relevant measure of ambulatory cancer patients' experiences of care. To make meaningful changes to nursing practice and health services, patient experience measures such as the PREM-C might support staff to identify areas for service improvement. IMPACT: Few reliable measures and less validated measures collect patients' perceptions of the quality of their healthcare provision. Rigorous psychometric testing of the newly developed PREM-C demonstrated good internal consistency, test-retest reliability, and external convergent and divergent validity. The PREM-C is a potentially relevant measure of cancer patients' experiences of care. It might be used to assess patient-centred care and guide safety and quality improvements in clinical settings. PREM-C use might inform service providers of experiences of care in their institution and inform policy and practice development. This measure is sufficiently generic, allowing potential use in other chronic disease populations. PATIENT OR PUBLIC CONTRIBUTION: This conduct of this study was supported by the participating patients of the hospital Cancer Outpatients Service.

The cancer nursing workforce in Australia: a national survey exploring determinants of job satisfaction.

BACKGROUND: To maintain and improve the quality of the cancer nursing workforce, it is crucial to understand the factors that influence retention and job satisfaction. We aimed to investigate the characteristics of cancer nurses in Australia and identify predictors of job satisfaction. METHODS: We analysed data from an anonymous cross-sectional survey distributed through the Cancer Nurses Society Australia membership and social media platforms from October 2021 to February 2022. The survey was compared to national nursing registration data. Data were analysed with non-parametric tests, and a stepwise, linear regression model was developed to best predict job satisfaction. RESULTS: Responses were received from 930 cancer nurses. Most respondents (85%) described themselves as experienced nurses, and more than half had post-graduate qualifications. We identified individual, organizational, and systemic factors that contribute to job satisfaction and can impact in workforce shortages. The findings include strategies to address and prioritize workforce challenges. There were 89 different titles for advanced practice nursing roles. Managing high workload was a reported challenge by 88%. Intention to stay less than 10 years was reported by nearly 60%; this was significantly correlated with job satisfaction and age. Significantly higher scores for job satisfaction were associated with those who had career progression opportunities, career development opportunities, adequate peer support and a clearly defined scope of role. Conversely, job satisfaction scores decreased the more people agreed there was a lack of leadership and they had insufficient resources to provide quality care. CONCLUSION: Cancer nurses are critical to the delivery of cancer care however, the workforce faces multiple challenges. This study provides an understanding of the Australian cancer nursing workforce characteristics, their roles and activities, and highlights important considerations for retaining nurses in the profession.

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.

The Evolution of Worldwide Nurse-Led Cancer Research in the Last 2 Decades (2004-2022): A Bibliometric Mapping and Visual Analysis.

BACKGROUND: Research led by nurses has evolved rapidly over the last 2 decades globally. Assessing the work that has been conducted so far can help the specialty to strategically shape future directions of nurse-led cancer research. OBJECTIVE: The aim of this study was to provide a comprehensive, up-to-date synthesis of all nurse-led cancer research published articles over 20 years. METHODS: A bibliometric analysis was used. Three databases were used to retrieve nurse-led cancer research publications for the period from January 1, 2004, to March 11, 2022. RESULTS: A total of 7043 original articles were retrieved. A significant increase in nurse-led cancer research over the past 2 decades was evident. The United States and United Kingdom were the most productive countries in terms of the number of published articles. Minimal international collaboration was observed among low- or middle-income countries versus high-income countries. Breast cancer, palliative care, and quality of life received the most attention in nurse-led cancer research, followed by education, pain, and communication. Very few publications addressed cancer prevention, breaking bad news, and cancer rehabilitation. CONCLUSION: Areas to consider in the future include more international collaborations on commonly agreed research agendas, capacity building to allow more research beyond the few countries that dominate the publications, and more focus on low- or middle-income countries. IMPLICATIONS FOR PRACTICE: The findings of this study provide direction for future research led by cancer nurses and the areas that warrant further investigation.

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.

Impact of exercise and/or dietary interventions, and their behaviour change techniques, on quality of life in middle-aged and older women following treatment for cancer: A systematic review.

Many middle-aged or older women are treated for cancer and their quality of life can be significantly impaired following treatment. Exercise and dietary interventions could address this. The aim of this review was to determine whether exercise and/or dietary interventions which are scaffolded by behaviour change theories and techniques are associated with improved quality of life in middle-aged and older women following cancer treatment. Secondary outcomes included self-efficacy, distress, waist circumference, and food variety. A search of CINAHL (EBSCOhost), Embase, MEDLINE (EBSCOhost), PsycINFO, PubMed and Scopus databases up to 17th November 2022 was conducted. A narrative summary was provided. Twenty articles discussing 18 independent randomised controlled trials/interventions were included, with a total of 1754 participants. No studies reported the outcomes of distress or food variety. Exercise and/or dietary interventions had mixed effects on quality of life, self-efficacy and waist circumference (positive effect: n = 4/14; n = 3/5; n = 4/7, respectively). Two-thirds of the interventions (exercise-only, n = 2; exercise and diet, n = 2) that demonstrated an improvement in quality-of-life scores were based upon Social Cognitive Theory. All studies that reported improvements in waist circumference employed combined exercise and dietary interventions, with individualised aspects for the dietary components. Exercise and/or dietary interventions could potentially enhance quality of life and self-efficacy, and reduce waist circumference, in middle-aged and older women treated for cancer. Although findings are currently mixed, avenues for the development of interventions include ensuring there is a theoretical underpinning and incorporating more behaviour change techniques in exercise and/or dietary interventions in this population.

Feasibility and acceptability of a culturally-adapted Women's Wellness After Cancer Programme for Chinese women treated for gynaecological cancer: A pilot randomised controlled trial.

Objective: To assess the feasibility and acceptability of a culturally-adapted Women's Wellness After Cancer Programme (WWACPHK) for improving health-related quality of life, anxiety and depressive symptoms and enhancing self-efficacy in engaging in healthy lifestyles among Chinese women treated for gynaecological cancer. Methods: This pilot randomised controlled trial was conducted from May to December 2018. Twenty-six women aged 18 or above who had completed treatment for gynaecological cancer were recruited from a gynaecology outpatient clinic of a public hospital in Hong Kong. They were randomised into intervention (n = 15) or control (n = 11) groups. All data collectors were blinded to the group allocation. Intervention participants were given access to the WWACPHK website and an online discussion forum facilitated by a trained research nurse for 12 weeks, while control participants received standard care. Trial feasibility was assessed by recruitment, consent, and retention rates and website use. Acceptability was explored through semi-structured interviews. Additionally, we trialed the data collection procedure and collected preliminary data on health-related quality of life, anxiety and depressive symptoms, dietary and exercise self-efficacy. Results: Of the 26 participants (Median age = 53.5 years) randomised, three participants dropped out of the study. Recruitment, consent and retention of participants and website use were satisfactory. No posting was made on the discussion forum. The intervention participants (n = 13) exhibited significantly greater improvement than the controls (n = 10) in perceived self-efficacy in adhering to an exercise routine at post-intervention (Cohen's d effect size(d) = 1.06, 95% confidence interval (CI): 0.18, 1.92) and 12-weeks after completion (d = 1.24, 95% CI: 0.32, 2.13). All participants were satisfied with the intervention. Conclusions: The WWACPHK is feasible and acceptable to Chinese women treated for gynaecological cancer and may improve their exercise self-efficacy. A larger-scale study is required to confirm its effects. Trial registrationhttps://www.isrctn.com identifier: ISRCTN12149499.

Efficacy of exercise interventions for women during and after gynaecological cancer treatment - a systematic scoping review.

PURPOSE: To systematically synthesise evidence of exercise intervention efficacy for physical/psychosocial outcomes that matter to women during/following treatment for gynaecological cancer. METHODS: Five databases were searched (PubMed, EMBASE, CINAHL, PsychInfo, Scopus). Exercise-only intervention studies that included women during/ following treatment for any gynaecological cancer, with/ without control comparison, on any physical or psychosocial outcome(s), were included and qualitatively appraised using the Revised Cochrane Risk of Bias tool and a modified Newcastle-Ottawa Scale. RESULTS: Seven randomised controlled trials (RCTs), three single-arm pre-post studies, and one prospective cohort study satisfied were included (11 studies). Most studies were completed following treatment (91%), included combined (aerobic and resistance; 36%) and aerobic (36%) training, were fully/mostly (63%) unsupervised, and had a moderate-to-high risk of bias. Overall, 33 outcomes (64% objectively-measured) were assessed. Improvements were observed in aerobic capacity (V̇O2 Peak +1.6 mL/kg/min, 6-minute walk distance +20-27 m), lower- (30-second sit-to-stand +2-4 repetitions) and upper-limb strength (30-second arm curl +5 repetitions; 1RM grip strength/chest press +2.4-3.1 kg), and agility (timed up-and-go -0.6 seconds). However, changes in quality of life, anthropometry/body composition, balance and flexibility were inconsistent. There was no evidence to support worsening of outcomes. CONCLUSION: Preliminary research into the role of exercise post-gynaecological cancer suggests an improvement in exercise capacity, muscular strength, and agility which, in the absence of exercise, typically decline following gynaecological cancer. Future exercise trials involving larger and more diverse gynaecological cancer samples will improve understanding of the potential and magnitude of effect of guideline-recommended exercise on outcomes that matter to patients.

The Effect of Exercise on Pain in People with Cancer: A Systematic Review with Meta-analysis.

INTRODUCTION: Cancer-related pain is common and undertreated. Exercise is known to have a pain-relieving effect in non-cancer pain. OBJECTIVES: This systematic review aimed to evaluate (1) the effect of exercise on cancer-related pain in all cancers, and (2) whether the effect of exercise differed according to exercise mode, degree of supervision, intervention duration and timing (during or after cancer treatment), pain types, measurement tool and cancer type. METHODS: Electronic searches were undertaken in six databases to identify exercise studies evaluating pain in people with cancer, published prior to 11 January 2023. All stages of screening and data extraction were conducted independently by two authors. The Cochrane risk of bias tool for randomised trials (RoB 2) was used and overall strength of evidence was assessed using the GRADE approach. Meta-analyses were performed overall and by study design, exercise intervention and pain characteristics. RESULTS: In total, 71 studies reported in 74 papers were eligible for inclusion. The overall meta-analysis included 5877 participants and showed reductions in pain favouring exercise (standardised mean difference - 0.45; 95% confidence interval - 0.62, - 0.28). For most (> 82%) of the subgroup analyses, the direction of effect favoured exercise compared with usual care, with effect sizes ranging from small to large (median effect size - 0.35; range - 0.03 to - 1.17). The overall strength of evidence for the effect of exercise on cancer-related pain was very low. CONCLUSION: The findings provide support that exercise participation does not worsen cancer-related pain and that it may be beneficial. Better pain categorisation and inclusion of more diverse cancer populations in future research would improve understanding of the extent of benefit and to whom. PROSPERO REGISTRATION NUMBER: CRD42021266826.

Efficacy of exercise training for improving vascular dysfunction in people with cancer: a systematic review with meta-analyses.

PURPOSE: Cancer treatments exert vascular toxic effects that can lead to the development of cardiovascular disease. Exercise training has the potential to prevent or reduce cancer treatment-induced damage to vascular structure and function. This systematic review with meta-analyses aimed to determine the isolated effects of exercise training on vascular outcomes in people with cancer. METHODS: Seven electronic databases were searched on 20 September 2021 to identify randomised controlled trials, quasi-randomised trials, pilot and cohort studies. Included studies implemented a structured exercise intervention and assessed vascular structure and/or function in people during or following cancer treatment. Meta-analyses examined the effects of exercise training on endothelial function (via brachial artery flow-mediated dilation) and arterial stiffness (via pulse wave velocity). Methodological quality was assessed using the Cochrane Quality Assessment tool and modified Newcastle-Ottawa Quality Appraisal tool. Grading of Recommendations, Assessment, Development and Evaluations framework was used to assess the certainty of evidence. RESULTS: Ten studies (discussed across 11 articles) met the inclusion criteria. Methodological quality of the included studies was moderate (71% average). Exercise improved vascular function when compared to control (standardised mean difference = 0.34, 95% CI (0.01, 0.67); p = 0.044: studies = 5, participants = 171), but not pulse wave velocity (standardised mean difference = - 0.64, 95% CI (- 1.29, 0.02); p = 0.056: studies = 4, participants = 333). The certainty of evidence was moderate for flow-mediated dilation and low for pulse wave velocity. CONCLUSIONS: Compared to usual care, exercise training significantly improves flow-mediated dilation (endothelial function) but not pulse wave analysis, in people treated for cancer. IMPLICATIONS FOR CANCER SURVIVORS: Exercise may improve vascular health in individuals during and following cancer treatment.

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.

Cultural Adaptation of the Younger Women's Wellness After Cancer Program for Younger Chinese Women With Breast Cancer: A Pilot Randomized Controlled Trial.

BACKGROUND: The incidence of breast cancer in younger women, that is, aged 50 years or younger, in Hong Kong is increasing. The Internet-based Younger Women's Wellness After Cancer Program (YWWACP) is a whole-lifestyle intervention that can help young women to manage their health and risks of chronic diseases. OBJECTIVES: The study aimed to test the acceptability and feasibility of the culturally adapted YWWACP in Hong Kong (YWWACPHK) and to evaluate its preliminary effects in improving health-related quality of life, distress, sexual function, menopausal symptoms, dietary intake, physical activity, and sleep among younger Chinese women with breast cancer. INTERVENTION/METHODS: Women aged 18 to 50 years with breast cancer were recruited from an oncology outpatient department. The participants in the intervention group received the 12-week YWWACPHK, whereas the control group received standard care. RESULTS: Sixty women consented to participate. At 12 weeks after intervention completion, the intervention group showed a significant increase in the pain subscale scores of sexual function and more improvement in the level of physical activity than the control group, with Hedge g effect sizes 0.66 and 0.65, respectively. Nineteen intervention group participants reported that they were satisfied with the program and suggestions for improvement were provided. CONCLUSION: The implementation of YWWACPHK is feasible. The preliminary findings suggest that YWWACPHK could increase the level of physical activity among the participants. IMPLICATIONS FOR PRACTICE: Nurses could utilize YWWACPHK to support younger Chinese patients with breast cancer to maintain a healthy lifestyle, subject to wider confirmation of these results through a larger study.

Prevalence and predictors of sleep problems in women following a cancer diagnosis: results from the women's wellness after cancer program.

PURPOSE: Using a discrete dataset from the Women's Wellness after Cancer Program (WWACP), we examine the prevalence and predictors of self-reported sleep problems in women previously treated for cancer. METHODS: Participants were 351 women (Mage = 53.2, SD = 8.8) from the WWACP who had completed surgery, chemotherapy and/or radiotherapy for breast, gynaecological or blood cancers within the previous 24 months. Sleep problems were measured using the Pittsburgh Sleep Quality Index (PSQI). Baseline data (i.e. prior to intervention randomisation) were analysed. RESULTS: Most women (59%) reported clinically significant sleep disturbance (PSQI > 5), 40% reported insufficient sleep duration (< 7 h), 38% self-reported poor sleep quality and 28% reported poor habitual sleep efficiency (sleep efficiency < 75%). Fewer psychological and vasomotor climacteric symptoms, age < 45 years and having a partner were associated with reduced odds (AOR < 1) of sleep problems. Higher levels of pain-related disability, and an intermediate compared to 'high' level of education, were associated with increased odds (AOR > 1) of sleep problems. CONCLUSIONS: These findings confirm previous studies that have found a high prevalence of sleep problems in women previously treated for cancer. A range of sociodemographic, climacteric and pain-related factors were associated with sleep problems in this study. IMPLICATIONS FOR CANCER SURVIVORS: Targeted interventions to improve sleep quality after cancer treatment should be explored in this population. Predictors identified in this study could inform intervention targeting and development.

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.

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.

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 ).

Co-production of a transdisciplinary assessment by researchers and healthcare professionals: a case study.

AIM: One definition of research co-production is a collaboration between researchers and healthcare professionals throughout a research process to facilitate knowledge translation and improve the clinical impact of research findings. In this paper, we present a case study of clinical research co-production and reflect on how the process was facilitated between researchers and healthcare professionals. Type of program or service: Development of a novel transdisciplinary assessment for implementation in an acute stroke unit (ASU). METHODS: Researchers and healthcare professionals integrated perspectives and co-produced a novel transdisciplinary assessment. Team-based activities were guided by a logic model, including task analysis and simulation testing. A logframe matrix was used to plan implementation strategies to mitigate potential risks. RESULTS: Research co-production was fundamental to integrating multiple perspectives to develop an effective, novel transdisciplinary assessment for patients with stroke. Preliminary data demonstrated that the transdisciplinary approach could save up to 103 minutes per patient in assessment time. LESSONS LEARNT: As the project evolved, the three most important factors for research co-production were 1) the right people to integrate critical disciplinary and pragmatic perspectives; 2) a project leader who was inclusive of perspectives held by researchers and healthcare professionals, and 3) structured and non-biased team discussions using a theoretical tool. We recommend these three factors be considered in future research co-production in healthcare settings.

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.