The trials and tribulations of conducting an m-health pilot randomized controlled trial to improve oral cancer therapy adherence: recommendations for future multisite, non-drug clinical trials

Abstract Objective Integrating mobile phone-based health (m-health) interventions into healthcare systems is one solution to improve access to services for the growing number of patients with chronic illness. Practical challenges such as poor recruitment and inadequate resource allocation can hamper the assessment of such interventions with clinical trial methodology. This paper highlights the challenges encountered during a pilot randomized controlled trial of an m-health medication adherence intervention and offers recommendations for future multi-site, non-drug clinical trials. Results Eighteen patients were recruited to the study; eight were randomly allocated to the intervention arm. Intervention participants responded to their daily medication-reminder text messages, indicating that medication had been taken or not, and nurses were able to organize their calls around their workload. The trial closed prematurely primarily due to inadequate numbers of eligible patients; however, other potentially resolvable feasibility issues were identified. These included lack of infrastructure at study sites, poor screening data acquisition and management processes, and inexperience in conducting supportive care trials at participating sites. M-health intervention trials are designed to inform implementation of best supportive care practice. Adequate skills and infrastructure are research prerequisites that require careful consideration and sufficient investment for the successful execution of multi-site supportive care trials. Trial registration Australian and New Zealand Clinical Trials Register: ACTRN1261200063586

Including migrant oncology patients in research : a multisite pilot randomised controlled trial testing consultation audio-recordings and question prompt lists

Background: Oncology patients who are migrants or refugees face worse outcomes due to language and communication barriers impacting care. Interventions such as consultation audio-recordings and question prompt lists may prove beneficial in mediating communication challenges. However, designing robust research inclusive of patients who do not speak English is challenging. This study therefore aimed to: a) pilot test and assess the appropriateness of the proposed research design and methods for engaging migrant populations, and b) determine whether a multi-site RCT efficacy assessment of the communication intervention utilising these methods is feasible. Methods: This study is a mixed-methods parallel-group, randomised controlled feasibility pilot trial. Feasibility outcomes comprised assessment of: i) screening and recruitment processes, ii) design and procedures, and iii) research time and costing. The communication intervention comprised audio-recordings of a key medical consultation with an interpreter, and question prompt lists and cancer information translated into Arabic, Greek, Traditional, and Simplified Chinese. Results: Assessment of feasibility parameters revealed that despite barriers, methods utilised in this study supported the inclusion of migrant oncology patients in research. A future multi-site RCT efficacy assessment of the INFORM communication intervention using these methods is feasible if recommendations to strengthen screening and recruitment are adopted. Importantly, hiring of bilingual research assistants, and engagement with community and consumer advocates is essential. Early involvement of clinical and interpreting staff as key stakeholders is likewise recommended. Conclusion: Results from this feasibility RCT help us better understand and overcome the challenges and misconceptions about including migrant patients in clinical research

Why is advance care planning underused in oncology settings? A systematic overview of reviews to identify the benefits, barriers, enablers, and interventions to improve uptake

BackgroundAdvance care planning (ACP) centres on supporting people to define and discuss their individual goals and preferences for future medical care, and to record and review these as appropriate. Despite recommendations from guidelines, rates of documentation for people with cancer are considerably low.AimTo systematically clarify and consolidate the evidence base of ACP in cancer care by exploring how it is defined; identifying benefits, and known barriers and enablers across patient, clinical and healthcare services levels; as well as interventions that improve advance care planning and are their effectiveness.MethodsA systematic overview of reviews was conducted and was prospectively registered on PROSPERO. PubMed, Medline, PsycInfo, CINAHL, and EMBASE were searched for review related to ACP in cancer. Content analysis and narrative synthesis were used for data analysis. The Theoretical Domains Framework (TDF) was used to code barriers and enablers of ACP as well as the implied barriers targeted by each of the interventions.ResultsEighteen reviews met the inclusion criteria. Definitions were inconsistent across reviews that defined ACP (n=16). Proposed benefits identified in 15/18 reviews were rarely empirically supported. Interventions reported in seven reviews tended to target the patient, even though more barriers were associated with healthcare providers (n=40 versus n=60, respectively).ConclusionTo improve ACP uptake in oncology settings; the definition should include key categories that clarify the utility and benefits. Interventions need to target healthcare providers and empirically identified barriers to be most effective in improving uptake.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?, identifier CRD42021288825

Correction to: Navigate: A study protocol for a randomised controlled trial of an online treatment decision aid for men with low-risk prostate cancer and their partners

© 2021, The Author(s). Following publication of the original article [1], we were notified of a typo in the spelling of the 10th author name, originally spelt as “Cavdon” instead of “Cavedon” (i.e., missing “e”). The original article has been corrected

Navigate: A study protocol for a randomised controlled trial of an online treatment decision aid for men with low-risk prostate cancer and their partners

© 2021, The Author(s). Background: Active surveillance (AS) is the disease management option of choice for low-risk prostate cancer. Despite this, men with low-risk prostate cancer (LRPC) find management decisions distressing and confusing. We developed Navigate, an online decision aid to help men and their partners make management decisions consistent with their values. The aims are to evaluate the impact of Navigate on uptake of AS; decision-making preparedness; decisional conflict, regret and satisfaction; quality of illness communication; and prostate cancer-specific quality of life and anxiety. In addition, the healthcare cost impact, cost-effectiveness and patterns of use of Navigate will be assessed. This paper describes the study protocol. Methods: Three hundred four men and their partners are randomly assigned one-to-one to Navigate or to the control arm. Randomisation is electronically generated and stratified by site. Navigate is an online decision aid that presents up-to-date, unbiased information on LRPC tailored to Australian men and their partners including each management option and potential side-effects, and an interactive values clarification exercise. Participants in the control arm will be directed to the website of Australia’s peak national body for prostate cancer. Eligible patients will be men within 3 months of being diagnosed with LRPC, aged 18 years or older, and who are yet to make a treatment decision, who are deemed eligible for AS by their treating clinician and who have Internet access and sufficient English to participate. The primary outcome is self-reported uptake of AS as the first-line management option. Secondary outcomes include self-reported preparedness for decision-making; decisional conflict, regret and satisfaction; quality of illness communication; and prostate cancer-specific quality of life. Uptake of AS 1 month after consent will be determined through patient self-report. Men and their partners will complete study outcome measures before randomisation and 1, 3 and 6 months after study consent. Discussion: The Navigate online decision aid has the potential to increase the choice of AS in LRPC, avoiding or delaying unnecessary radical treatments and associated side effects. In addition, Navigate is likely to reduce patients’ and partners’ confusion and distress in management decision-making and increase their quality of life. Trial registration: Australian and New Zealand Clinical Trial Registry ACTRN12616001665426. Registered on 2 December 2016. All items from the WHO Trial Registration Data set can be found in this manuscript

Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: a cluster randomised controlled trial

BACKGROUND: Radiotherapy for localised prostate cancer has many known and distressing side effects. The efficacy of group interventions for reducing psychological morbidity is lacking. This study investigated the relative benefits of a group nurse-led intervention on psychological morbidity, unmet needs, treatment-related concerns and prostate cancer-specific quality of life in men receiving curative intent radiotherapy for prostate cancer. METHODS: This phase III, two-arm cluster randomised controlled trial included 331 men (consent rate: 72 %; attrition: 5 %) randomised to the intervention (n = 166) or usual care (n = 165). The intervention comprised four group and one individual consultation all delivered by specialist uro-oncology nurses. Primary outcomes were anxious and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale. Unmet needs were assessed with the Supportive Care Needs Survey-SF34 Revised, treatment-related concerns with the Cancer Treatment Scale and quality of life with the Expanded Prostate Cancer Index -26. Assessments occurred before, at the end of and 6 months post-radiotherapy. Primary outcome analysis was by intention-to-treat and performed by fitting a linear mixed model to each outcome separately using all observed data. RESULTS: Mixed models analysis indicated that group consultations had a significant beneficial effect on one of two primary endpoints, depressive symptoms (p = 0.009), and one of twelve secondary endpoints, procedural concerns related to cancer treatment (p = 0.049). Group consultations did not have a significant beneficial effect on generalised anxiety, unmet needs and prostate cancer-specific quality of life. CONCLUSIONS: Compared with individual consultations offered as part of usual care, the intervention provides a means of delivering patient education and is associated with modest reductions in depressive symptoms and procedural concerns. Future work should seek to confirm the clinical feasibility and cost-effectiveness of group interventions

The James Webb Space Telescope Mission

Twenty-six years ago a small committee report, building on earlier studies, expounded a compelling and poetic vision for the future of astronomy, calling for an infrared-optimized space telescope with an aperture of at least $4m$. With the support of their governments in the US, Europe, and Canada, 20,000 people realized that vision as the $6.5m$ James Webb Space Telescope. A generation of astronomers will celebrate their accomplishments for the life of the mission, potentially as long as 20 years, and beyond. This report and the scientific discoveries that follow are extended thank-you notes to the 20,000 team members. The telescope is working perfectly, with much better image quality than expected. In this and accompanying papers, we give a brief history, describe the observatory, outline its objectives and current observing program, and discuss the inventions and people who made it possible. We cite detailed reports on the design and the measured performance on orbit.Comment: Accepted by PASP for the special issue on The James Webb Space Telescope Overview, 29 pages, 4 figure

Employment through residency programs a strategy to address the workforce crisis in psychiatric nursing /

Australia, like most countries in the world, is facing a crisis regarding the recruitment and retention of nurses. This situation is particularly notable for psychiatric nursing, a specialty not generally popular among undergraduate nursing students. To date, the nursing literature has tended to identify the problem, with less attention to the exploration of possible solutions. The aim of this article is to explore the literature concerning residency programs for nursing students. Although limited, the literature suggests potential benefits to this program, including improvements in competency and confidence, resulting in reduced need for lengthy orientation for new graduates and overall improvements in recruitment and retention rates for psychiatric nurses. In conclusion, residency programs for undergraduate nursing students could provide a useful strategy to improve the image of psychiatric nursing and attract new graduates. Further research is required to assess the applicability of this model in Australia

Critique of Falloon and the Optimal Treatment Project

The Optimal Treatment Project advocated by Falloon has been demonstrated through the scientific research literature to be efficient and effective treatment strategies for people experiencing severe mental illness. For this reason, there is little critique of this approach. While the potential value of the project is acknowledged, it is important to identify the appropriateness of the model for specific services and to understand comprehensively the resources necessary for successful implementation. The aim of this paper is to review the literature in relation to the Optimal Treatment Project with a view to exploring the complexities associated with the model. It is concluded that the involvementof multiple stakeholders, including consumers of mental health services, should become an essential element of any implementation strategy