Outcomes of a randomized controlled trial assessing a smartphone Application to reduce unmet needs among people diagnosed with CancEr (ACE).

BACKGROUND: Smartphone technology represents an opportunity to deliver practical solutions for people affected by cancer at a scale that was previously unimaginable, such as information, appointment monitoring, and improved access to cancer support services. This study aimed to determine whether a smartphone application (app) reduced the unmet needs among people newly diagnosed with cancer. METHODS: A single blind, multisite randomized controlled trial to determine the impact of an app-based, 4-month intervention. Newly diagnosed cancer patients were approached at three health service treatment clinics. RESULTS: Eighty-two people were randomized (intervention; n = 43 and control; n = 39), average age was 59.5 years (SD: 12.9); 71% female; 67% married or in a de facto relationship. At baseline, there were no differences in participants' characteristics between the groups. No significant effects, in reducing unmet needs, were demonstrated at the end of intervention (4-month) or 12-month follow-up. Overall, 94% used the app in weeks 1-4, which decreased to 41% in weeks 13-16. Mean app use time per participant: Cancer Information, 6.9 (SD: 18.9) minutes; Appointment Schedule, 5.1 (SD: 9.6) minutes; Cancer Services 1.5 minutes (SD: 6.8); Hospital Navigation, 1.4 (SD: 2.8) minutes. CONCLUSIONS: Despite consumer involvement in the design of this smartphone technology, the app did not reduce unmet needs. This may have been due to the study being underpowered. To contribute to a meaningful understanding and improved implementation of smartphone technology to support people affected by cancer, practical considerations, such as recruitment issues and access to, and confidence with, apps, need to be considered. Australian New Zealand Clinical Trials Registration (ACTRN) Trial Registration: 12616001251415; WEF 7/9/2016.

Lower smoking rates and increased perceived harm of cigarettes among French adults one year after comprehensive tobacco control measures.

CONTEXT: France has high smoking rates, and recently intensified tobacco control policies spearheaded by the introduction of plain tobacco packaging (PP), and an increase in graphic health warnings (GHW). We examine smoking and e-cigarettes use rates, as well as smoking-related perceptions before (2016) and one year after (2017) comprehensive tobacco control measures. METHODS: DePICT is a two waves cross-sectional national telephone survey of French adults aged 18-64 years (2016: 4456 - 2017: 4114). Data were weighted to be representative of the French adult population. Adjusted prevalence ratios (PR, 95% CI) estimating changes between the two study waves were calculated using multivariate Log-Binomial regression models. MAIN FINDINGS: In 2017, as compared with 2016, smoking rates (PR = 0.93 (0.88-0.99) and current e-cigarette use (PR = 0.76 (0.61-0.96)) decreased in France. Further, French adults were more likely to report fear of the consequences of smoking (PR = 1.10 (1.06-1.14)) and that smoking is dangerous (PR = 1.08 (1.06-1.11)). Smokers were also more likely to report that health messages on tobacco products are efficient (PR = 1.18 (1.05-1.32)). CONCLUSIONS: Our study provides early and encouraging results on potential effects of the comprehensive tobacco control strategies in France introduced in 2017, including PP and larger GHW. Our findings also suggest that e-cigarettes did not replace traditional smoking.

"An Ambition to Make People Feel at Home" or "The Emperor's New Clothes"? Professional stakeholder views of wellness centres in cancer care.

OBJECTIVE: Wellness centres offer people affected by cancer to access to information and services in a supportive environment. This study aimed to understand stakeholder opinions and perspectives about the potential of wellness centres to contribute to cancer care. METHODS: This study adopted a qualitative approach with health professionals, leaders of key cancer organisations and cancer policy stakeholders interviewed. Results were analysed with thematic analysis. RESULTS: Twenty-three stakeholders representing 13 organisations participated. The following three key themes were identified: (a) The promise and ambition of wellness centres; (b) The hesitations and questions; and (c) Optimising wellness. While many recognised the ambition of wellness centres to offer non-clinical spaces and support for patients and family, there were several concerns raised about the drivers, evidence, throughput, access and equity of services, in the context of other cancer care priorities. Participants made recommendations that focused on use of data; models of community or clinical integration; accessibility and scope; approaches to engaging minority or disadvantaged groups and contribution to cancer care and psycho-oncology. CONCLUSION: Professional stakeholders hold varied views about the potential of wellness centres in contributing to cancer care. Research opportunities include understanding models of community clinical engagement and how to engage minority or disadvantaged populations to ensure equity of access.

Plain tobacco packaging, increased graphic health warnings and adolescents' perceptions and initiation of smoking: DePICT, a French nationwide study.

BACKGROUND: Plain packaging (PP) of tobacco products and increased graphic warnings may contribute to lower attractiveness of smoking, particularly among youths. In France, this policy was introduced on 1 January 2017. We examined changes in smoking-related perceptions and behaviours among a nationwide sample of French adolescents before (2016) and 1 year post (2017) implementation. METHODS: DePICT is a two-wave cross-sectional national telephone survey of adolescents aged 12-17 years per study wave (2016: n=2046 2017: n=1999). All participants reported smoking-related perceptions, as well as ever and current tobacco use. Smokers were also asked about their perceptions of tobacco brands. Data were weighted to be representative of youths in the French population: adjusted prevalence ratios (PRs, 95% CI) estimating changes between the two study waves were calculated using multivariate log-binomial regression models. RESULTS: In 2017, as compared with 2016, French adolescents were more likely to report fear of the consequences of smoking (PR=1.06, 95% CI 1.02 to 1.09) and that smoking is dangerous (PR=1.08, 95% CI 1.05 to 1.11). They were also less likely to report that their friends (PR=0.61, 95% CI 0.54 to 0.70) and family (PR=0.51, 95% CI 0.44 to 0.60) accept smoking. Additionally, smoking initiation significantly decreased (PR=0.96, 95% CI 0.93 to 0.98) and a non-statistically significant drop in current tobacco use was observed (PR=0.93, 95% CI 0.78 to 1.11). Smokers' attachment to their tobacco brand also decreased (PR=0.47, 95% CI 0.30 to 0.73). CONCLUSION: Our findings suggest that PP and increased graphic warnings could contribute to changes in smoking norms and rates among adolescents.

Caregivers' information needs and their 'experiences of care' during treatment are associated with elevated anxiety and depression: a cross-sectional study of the caregivers of renal cancer survivors.

PURPOSE: This study aims to examine the unmet needs and psychological distress (anxiety and depression) in family caregivers of renal cell carcinoma survivors. METHODS: A cross-sectional study design was used. Unmet needs were assessed with the Supportive Care Needs Survey-Partners and Caregivers (SCNS-P&C) questionnaire, and psychological distress was measured with the Hospital Anxiety and Depression Scale (HADS) in a telephone survey of 196 caregivers of renal cell carcinoma (RCC) survivors. Chi-square tests examined bivariate relationships, and multivariate logistic regression examined the associations between anxiety and depression and of unmet needs with caregivers' experience of patients' care, time spent caregiving, caregivers' demographic characteristics and patients' disease stage. RESULTS: Sixty-four percent of caregivers had at least one low, moderate or high unmet need, with 53 % reporting at least three needs and 29 % reporting 10 or more unmet needs (median 2, range 0-38). Elevated anxiety (HADS-A > 8) and depression (HADS-D > 8) were found in 29 and 11 % of the sample, respectively. Psychological and emotional needs were associated with advanced cancer stage (stages 3 and 4) (OR 3.07, 95 % CI 1.35-6.76) and with experience of care during surgery (OR 0.87, 95 % CI 0.78-0.99). Healthcare service needs were associated with time spent caregiving, with caregivers spending >1 h/day in the past week having three times higher odds (OR 3.44, 95 % CI 1.52-7.72) than those not spending any time. Odds of experiencing information needs were lower in caregivers who were in a relationship (OR 0.20, 95 % CI 0.04-0.83). Elevated anxiety (OR 1.59, 95 % CI 1.09-2.33) and depression (OR 2.02, 95 % CI 1.08-3.79) were associated with unmet information needs. Depression was also associated with experiences of care during treatment (OR 0.69, 95 % CI 0.49-0.96). CONCLUSION: RCC caregivers' unmet information needs are associated with elevated anxiety and depression. Improved experiences of cancer care are associated with lower odds of unmet needs and elevated depression in RCC caregivers.

Acute hyperkalemia associated with inhalation of a potent ENaC antagonist: Phase 1 trial of GS-9411.

BACKGROUND: Inhaled epithelial sodium channel (ENaC) blockers are designed to increase airway surface liquid volume, thereby benefiting cystic fibrosis patients. This study evaluated the safety, tolerability, and pharmacokinetics of multiple doses of ENaC blocker GS-9411, in healthy participants. METHODS: This randomized, double-blind, placebo-controlled, parallel-group, residential, Phase 1 study evaluated inhaled GS-9411 (2.4, 4.8, and 9.6 mg) or placebo, dosed twice daily for 14 days. RESULTS AND CONCLUSIONS: GS-9411 was well tolerated; 86.1% of treated participants completed dosing (n=31/36). Cough and dizziness (27.8% participants each; most of mild severity) were the most commonly reported adverse events and occurred in both placebo and GS-9411 treatment groups. Arrhythmias were not observed for GS-9411-treated participants, and electrocardiographic changes were not considered clinically significant. Serum potassium levels exceeded the upper limit of normal (>5 mmol/L), 4 hr after the morning dose in GS-9411 (n=16/24) and placebo (n=4/12) treatment groups (38 incidences total). Retesting revealed levels had returned to normal within 2-3 hr. In urine electrolyte analyses, obtained 0-6 hr after the Day 1 morning dose, mean sodium/potassium ratios significantly increased from values 0-6 hr before dosing. Increased urine sodium/potassium ratios corresponded with high urine concentrations of active GS-9411 metabolites, which inhibited sodium reabsorption in the kidney, leading to the observed transient hyperkalemia in these participants. Inhaled GS-9411 was well tolerated except for the emergence of transient clinically significant hyperkalemia; this finding resulted in termination of further clinical development of this drug and will necessitate development of a new generation of ENaC blockers, which provide a sustained improvement in mucociliary clearance, while reducing renal exposure to ENaC blockade. Transient increases in mean urine sodium/potassium ratios appeared to be the first signal of electrolyte imbalances resulting from drug-induced block of ENaC in the kidney. The results of this study strongly suggest that clinical trials of novel ENaC blockers will require intensive measurement of plasma and urine electrolyte levels.

Reducing the psychological distress of family caregivers of home-based palliative care patients: short-term effects from a randomised controlled trial.

BACKGROUND: Palliative care is expected to incorporate comprehensive support for family caregivers given that many caregivers suffer psychological morbidity. However, systematically implemented evidence-based psychological support initiatives are lacking. AIM: The objective of this study was to prepare caregivers for the role of supporting a patient with advanced cancer receiving home-based palliative care by offering a one-to-one psycho-educational intervention. We hypothesised that primary family caregivers who participated in the intervention would report decreased psychological distress (primary outcome), fewer unmet needs and increased levels of perceived preparedness, competence and positive emotions. METHODS: A three-arm randomised controlled trial was conducted comparing two versions of the intervention (one face-to-face visit versus two visits) plus standard care to a control group (standard care) across four sites in Australia. RESULTS: A total of 298 participants were recruited; 148 were in the Control condition, 57 in Intervention 1 (one visit) and 93 in Intervention 2 (two visits). Relative to participants in the control group; the psychological well-being of participants in the intervention condition was improved by a small amount but non-significantly. No significant reduction in unmet needs or improvements in positive aspects of caregiving amongst the intervention group were identified. However, the intervention demonstrated significant improvements in participants' levels of preparedness and competence for Intervention 2. CONCLUSION/IMPLICATIONS: This research adds to accumulating body of evidence demonstrating that relatively short psycho-educational interventions can enable family caregivers to feel more prepared and competent in the role of supporting a dying relative. Further investigation is required to determine the longer term outcomes of such interventions.

Multidisciplinary team developed and implemented protocols to assist mechanical ventilation weaning: a systematic review of literature.

AIM: The aim of this review was to determine if ventilation-weaning protocols developed and implemented by multidisciplinary teams (MDTs) reduced the duration of mechanical ventilation in adult intensive care patients compared to usual care. METHOD: A systematic review was conducted to review published research studies from January 1999 to June 2009 to identify and analyse the best available evidence on MDT-based weaning protocols in adult intensive care patients. All relevant studies based on electronic searches of MEDLINE, EMBASE, CINAHL, the Cochrane Controlled Trials Registry and the Cochrane Database of Systematic Reviews were included. Where possible data were pooled and a meta-analysis performed. A narrative synthesis of data was conducted to provide a critical appraisal of nonrandomised controlled trials included in the review. RESULTS: Three pre- and postinterventional studies were identified for inclusion in this review. Results show equivocal support for weaning protocols developed and implemented by MDTs for reducing duration of mechanical ventilation. CONCLUSION: Communication and organizational processes must be addressed for multidisciplinary protocols to be effective. Due to methodological limitations of included studies, large randomised controlled trials are required to provide high-level evidence of the effects of MDT-based protocols on duration of mechanical ventilation.

Discussing the transition to palliative care: evaluation of a brief communication skills training program for oncology clinicians.

OBJECTIVE: Discussing the transition from active anti-cancer treatment to palliative care can be difficult for cancer patients and oncology health professionals (OHP). We developed a brief communication skills workshop to assist OHP with these conversations, and examined satisfaction with the workshop and perceived confidence regarding these discussions. METHOD: Interactive workshops were conducted by trained facilitators and included cognitive, behavioral, and experiential components. The major component of the workshop involved role-plays with trained actors (simulated patients). Participants completed an evaluation questionnaire. RESULTS: Sixty-two OHP participated in workshops. Overall, participants were highly satisfied with the workshop content and format. All participants felt the workshop provided relevant practical information, and > 80% thought that participation benefited their work. Over 98% said that the workshop had increased confidence in their communication skills. SIGNIFICANCE OF RESULTS: Participants were very satisfied with the workshop, and thought that participation increased confidence in communicating about the transition to palliative care. Dissemination of this model of communication skills training seems warranted.

Genetic influences on handedness: data from 25,732 Australian and Dutch twin families.

Handedness refers to a consistent asymmetry in skill or preferential use between the hands and is related to lateralization within the brain of other functions such as language. Previous twin studies of handedness have yielded inconsistent results resulting from a general lack of statistical power to find significant effects. Here we present analyses from a large international collaborative study of handedness (assessed by writing/drawing or self report) in Australian and Dutch twins and their siblings (54,270 individuals from 25,732 families). Maximum likelihood analyses incorporating the effects of known covariates (sex, year of birth and birth weight) revealed no evidence of hormonal transfer, mirror imaging or twin specific effects. There were also no differences in prevalence between zygosity groups or between twins and their singleton siblings. Consistent with previous meta-analyses, additive genetic effects accounted for about a quarter (23.64%) of the variance (95%CI 20.17, 27.09%) with the remainder accounted for by non-shared environmental influences. The implications of these findings for handedness both as a primary phenotype and as a covariate in linkage and association analyses are discussed.