Multi-center, pragmatic, cluster-randomized, controlled trial of standardized peritoneal dialysis (PD) training versus usual care on PD-related infections (the TEACH-PD trial): trial protocol.

BACKGROUND: Peritoneal dialysis (PD)-related infections, such as peritonitis, exit site, and tunnel infections, substantially impair the sustainability of PD. Accordingly, PD-related infection is the top-priority research outcome for patients and caregivers. While PD nurse trainers teach patients to perform their own PD, PD training curricula are not standardized or informed by an evidentiary base and may offer a potential approach to prevent PD infections. The Targeted Education ApproaCH to improve Peritoneal Dialysis outcomes (TEACH-PD) trial evaluates whether a standardized training curriculum for PD nurse trainers and incident PD patients based on the International Society for Peritoneal Dialysis (ISPD) guidelines reduces PD-related infections compared to usual training practices. METHODS: The TEACH-PD trial is a registry-based, pragmatic, open-label, multi-center, binational, cluster-randomized controlled trial. TEACH-PD will recruit adults aged 18 years or older who have not previously undergone PD training at 42 PD treatment units (clusters) in Australia and New Zealand (ANZ) between July 2019 and June 2023. Clusters will be randomized 1:1 to standardized TEACH-PD training curriculum or usual training practice. The primary trial outcome is the time to the first occurrence of any PD-related infection (exit site infection, tunnel infection, or peritonitis). The secondary trial outcomes are the individual components of the primary outcome, infection-associated catheter removal, transfer to hemodialysis (greater than 30 days and 180 days), quality of life, hospitalization, all-cause death, a composite of transfer to hemodialysis or all-cause death, and cost-effectiveness. Participants are followed for a minimum of 12 months with a targeted average follow-up period of 2 years. Participant and outcome data are collected from the ANZ Dialysis and Transplant Registry (ANZDATA) and the New Zealand Peritoneal Dialysis (NZPD) Registry. This protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. DISCUSSION: TEACH-PD is a registry-based, cluster-randomized pragmatic trial that aims to provide high-certainty evidence about whether an ISPD guideline-informed standardized PD training curriculum for PD nurse trainers and adult patients prevents PD-related infections. TRIAL REGISTRATION: ClinicalTrials.gov NCT03816111. Registered on 24 January 2019.

A pilot, multisite, randomized controlled trial of a self-directed coping skills training intervention for couples facing prostate cancer: accrual, retention, and data collection issues.

PURPOSE: To examine the acceptability of the methods used to evaluate Coping-Together, one of the first self-directed coping skill intervention for couples facing cancer, and to collect preliminary efficacy data. METHODS: Forty-two couples, randomized to a minimal ethical care (MEC) condition or to Coping-Together, completed a survey at baseline and 2 months after, a cost diary, and a process evaluation phone interview. RESULTS: One hundred seventy patients were referred to the study. However, 57 couples did not meet all eligibility criteria, and 51 refused study participation. On average, two to three couples were randomized per month, and on average it took 26 days to enrol a couple in the study. Two couples withdrew from MEC, none from Coping-Together. Only 44 % of the cost diaries were completed, and 55 % of patients and 60 % of partners found the surveys too long, and this despite the follow-up survey being five pages shorter than the baseline one. Trends in favor of Coping-Together were noted for both patients and their partners. CONCLUSIONS: This study identified the challenges of conducting dyadic research, and a number of suggestions were put forward for future studies, including to question whether distress screening was necessary and what kind of control group might be more appropriate in future studies.

The PACT study protocol: a time series study investigating the impact, acceptability and cost of an integrated model for psychosocial screening, care and treatment of patients with urological and head and neck cancers.

INTRODUCTION: While there is good evidence of the effectiveness of a variety of interventions and services to prevent and/or relieve distress experienced by people affected by cancer, much of this psychosocial morbidity is undetected and untreated, with consequent exacerbated suffering, decreased satisfaction with care, impaired adherence to treatment regimens and poorer morbidity and mortality outcomes. The objective of this study is to develop, implement and assess the impact, acceptability and cost of an integrated, patient-centred Psychosocial Assessment, Care and Treatment (PACT) model of care for patients with urological and head and neck cancers. METHODS AND ANALYSIS: A time series research design will be used to test the PACT model of care, newly introduced in an Australian tertiary hospital. The primary outcome is system-level impact, assessed through audit of patients' medical records and Medicare claims for follow-up care. The secondary outcomes are impact of the model on patients' experience and healthcare professionals' (HCPs) knowledge and confidence, assessed via patient and HCP surveys at baseline and at follow-up. Acceptability of the intervention will be assessed through HCP interviews at follow-up, and cost will be assessed from Medicare and Pharmaceutical Benefits Scheme claims information and information logged pertaining to intervention activities (eg, time spent by the newly appointed psycho-oncology staff in direct patient contact, providing training sessions, engaging in case review) and their associated costs (eg, salaries, training materials and videoconferencing). ETHICS AND DISSEMINATION: Ethics approval was obtained from the Human Research Ethics Committees of Hunter New England Local Health District and the University of NSW. RESULTS: The results will be widely disseminated to the funding body and through peer-reviewed publications, HCP and consumer publications, oncology conferences and meetings. TRIAL REGISTRATION: The study is registered with the Australian New Zealand Clinical Trials Registry with registration number ACTRN12613000916741.

"You need something like this to give you guidelines on what to do": patients' and partners' use and perceptions of a self-directed coping skills training resource.

PURPOSE: This study aims to report on the acceptability of a self-directed coping skills intervention, called Coping-Together, for patients affected by cancer and their partners, including the strengths and limitations of the intervention design. METHODS: This initial version of Coping-Together included a series of four booklets, which aimed to provide practical coping strategies for the day-to-day management of common physical and psychosocial challenges. Thirty semi-structured interviews were conducted with 27 patients and/or 14 partners. Interviews were audiorecorded, transcribed verbatim, and analyzed for content. RESULTS: Participants endorsed the self-directed format, and the focus of Coping-Together on practical information was a feature that set it apart from other resources. The majority of participants interviewed felt that the proposed coping strategies were "doable"; however, only half of the participants reported learning new coping skills after reading the booklets. Additional benefits of reading the booklets were increasing awareness of challenges to prepare for, giving hope that something can help you "pull through", providing a sense of normality, connecting patients and partners to people and services, and complementing support received from health professionals. Despite the general acceptability of the intervention, some aspects of its design were criticized, including the workbook-like exercises, expectations about using the resource together, level of guidance provided, and amount of information included. In general, most participants felt that too much negative information was included, whereas more experiential information was desired. CONCLUSIONS: Preliminary evaluation of Coping-Together supported its practical approach and highlighted improvements to enhance its contribution to patient and partner coping.