Randomized controlled trial (RCT) of symptom screening with targeted early palliative care (STEP) versus usual care in patients with advanced cancer

Background: To direct limited specialized palliative care resources to patients in greatest need, we developed STEP (Symptom screening with Targeted Early Palliative care). STEP entails symptom screening (ESAS-r) at each oncology clinic visit and triggered alerts (for moderate-high physical and psychological symptoms) to a nurse who calls the patient to offer a palliative care clinic (PCC) visit. We conducted a phase III RCT to assess the impact of STEP versus usual care on quality of life and other patient-reported outcomes (PROs). Methods: Adults with advanced cancer were recruited from medical oncology clinics at the Princess Margaret Cancer Centre, Toronto, Canada. Consenting patients with oncologist-assessed ECOG 0-2 and estimated survival of 6-36 months were enrolled and block randomized (stratified by tumour site and symptom severity) to STEP or usual care. Participants completed measures of quality of life (FACT-G7), depression (PHQ-9), symptom control (ESASr-CS), and satisfaction with care (FAMCARE-P16) at baseline, 2, 4 and 6 months. The primary outcome was FACT-G7 at 6 months, with a planned sample size of 261/arm. Results: From 8/2019 to 3/2020, 69 patients were enrolled: 33 randomized to STEP and 36 to usual care. The trial was then halted permanently due to the COVID-19 pandemic, owing to substantial changes to elements of STEP (shift to virtual symptom screening and palliative care) and usual care (shift to virtual oncology care). Median age was 64 years (range 25-87) and 62% (43/69) were women;study arms were balanced at baseline except gender, with more women randomized to STEP. Within the STEP arm, 20 (61%) participants triggered a nurse's call to offer a PCC visit, of whom 13 attended the clinic at least once. All outcomes tended to be better in the STEP arm compared to usual care, particularly depression and satisfaction with care at 6 months;however, results were not statistically significant (Table). Conclusions: STEP holds promise for improving quality of life and other PROs in patients with advanced cancer and effectively directing early palliative care towards those who need it most. In response to the pandemic, an online version of STEP has been developed and a further trial is in progress.

SYMPTOM SCREENING WITH TARGETED EARLY PALLIATIVE CARE (STEP) VERSUS USUAL CARE FOR PATIENTS WITH ADVANCED CANCER: A RANDOMIZED CONTROLLED TRIAL

Introduction To direct scant specialized palliative care (PC) resources to patients in greatest need, we developed the STEP intervention (Symptom screening with Targeted Early Palliative care). STEP entails symptom screening with ESAS-r at each oncology visit and triggered alerts (for moderatehigh symptoms) to a nurse who calls the patient to offer a PC clinic visit. Methods Consenting adults with advanced cancer, ECOG 0-2, attending medical oncology clinics at the Princess Margaret Cancer Centre, were randomized to STEP or usual care. Participants completed quality of life (FACTG7), depression (PHQ-9), symptom control (ESASr-CS), and satisfaction with care (FAMCARE-P16) measures at baseline, 2, 4, and 6 months. The primary outcome was FACT-G7 at 6 months. Results From August 2019 to March 2020, 33 patients were randomized to STEP and 36 to usual care. The trial was subsequently permanently halted due to the COVID-19 pandemic. Groups were balanced at baseline except gender, with more females in the STEP arm (Table 1). In the STEP arm, 20 participants triggered a nurse 's call, of whom 13 had ≥1 PC clinic visit. At 6 months, all outcomes tended to be better in the STEP arm compared to usual care, particularly depression and satisfaction with care;however, results were not statistically significant (Table 2, Figure 1). Conclusions STEP holds promise for improving outcomes in patients with advanced cancer. An online version (eSTEP) is being developed in response to the COVID-19 pandemic.

Prostate pathway embedded comparative trial: The ip3-prospect study

Introduction & Objectives: The strength of evidence to support much of how we treat localized prostate cancer can be underwhelming. This is not due to a lack of trying. We have attempted many trials to assess interventions for localized prostate cancer which have unfortunately failed to accrue. There have been admirable exceptions, but many others have struggled. There are multiple reasons for this including a lack of equipoise to clinical questions posed amongst clinicians, or potential participants not wanting to sacrifice their health autonomy when joining trials. A further factor may be our reliance on the head-to-head Randomised Controlled Trial (RCT). We aimed to determine whether level-one evidence might be gathered using a novel trial design. Materials & Methods: IP3-PROSPECT (NCT04400656) is a cohort multiple RCT, designed to test multiple prostate cancer interventions from eligible men in one cohort. The design is based on the Zelen randomisation concept in which participants are randomised before consent in an effort to address accrual rates and to reduce potential bias of participants to control treatments. To address the ethical implications using of Zelen, the cmRCT design uses two points of consent. First, at point-of-consent 1, participants on invitation to the cohort, consent to being randomly invited in future to consider interventions for which they might be eligible. Later, at point-of-consent 2, participants are then randomly invited to consider interventions they are eligible for, and consent only to those they wish to. To include as broad a group of participants as possible our inclusion criteria are deliberately broad. These comprise those aged >/=18 years with a life expectancy of >/=5 years, who are referred for clinical suspicion of prostate cancer, or those in whom there is already a diagnosis of prostate cancer referred for specialist treatment. Acceptability and feasibility will be measured by a combination of quantitative and qualitative methods. The primary outcome is the rate of consent to inclusion to the IP3-PROSPECT cohort. Secondary outcomes include the completeness of data collection at sites and return rates of patient reported outcome measures using validated questionnaires. We will also interview patients and healthcare professionals to explore their thoughts on the implementation, practicality and efficiency of IP3-PROSPECT. Results: Enrolment to IP3-PROSPECT began in September 2020 and is recruiting to schedule despite the global COVID19 pandemic. 26 patients have been recruited at two centres, and four further sites are expected to open in the first half of 2021. Conclusions: The trial reports a good pace of recruitment and expects to complete in the third quarter of 2021. Interest amongst men referred for investigations of prostate cancer is high and we expect to demonstrate the feasibility of developing a cmRCT cohort of men referred for investigations of prostate cancer within the study period.

Changes in the Management of Patients having Radical Radiotherapy for Lung Cancer during the First Wave of the COVID-19 Pandemic in the UK.

AIMS: In response to the COVID-19 pandemic, guidelines on reduced fractionation for patients treated with curative-intent radiotherapy were published, aimed at reducing the number of hospital attendances and potential exposure of vulnerable patients to minimise the risk of COVID-19 infection. We describe the changes that took place in the management of patients with stage I-III lung cancer from April to October 2020. MATERIALS AND METHODS: Lung Radiotherapy during the COVID-19 Pandemic (COVID-RT Lung) is a prospective multicentre UK cohort study. The inclusion criteria were: patients with stage I-III lung cancer referred for and/or treated with radical radiotherapy between 2nd April and 2nd October 2020. Patients who had had a change in their management and those who continued with standard management were included. Data on demographics, COVID-19 diagnosis, diagnostic work-up, radiotherapy and systemic treatment were collected and reported as counts and percentages. Patient characteristics associated with a change in treatment were analysed using multivariable binary logistic regression. RESULTS: In total, 1553 patients were included (median age 72 years, 49% female); 93 (12%) had a change to their diagnostic investigation and 528 (34%) had a change to their treatment from their centre's standard of care as a result of the COVID-19 pandemic. Age ≥70 years, male gender and stage III disease were associated with a change in treatment on multivariable analysis. Patients who had their treatment changed had a median of 15 fractions of radiotherapy compared with a median of 20 fractions in those who did not have their treatment changed. Low rates of COVID-19 infection were seen during or after radiotherapy, with only 21 patients (1.4%) developing the disease. CONCLUSIONS: The COVID-19 pandemic resulted in changes to patient treatment in line with national recommendations. The main change was an increase in hypofractionation. Further work is ongoing to analyse the impact of these changes on patient outcomes.

Critical care triage during the COVID-19 pandemic in South Africa: A constitutional imperative!

Triage and rationing of scarce intensive care unit (ICU) resources are an unavoidable necessity. In routine circumstances, ICU triage is premised on the best interests of an individual patient; however, when increased demand exceeds capacity, as during an infectious disease outbreak, healthcare providers need to make difficult decisions to benefit the broader community while still respecting individual interests. We are currently living through an unprecedented period, with South Africa (SA) facing the challenges of the global COVID-19 pandemic. The Critical Care Society of Southern Africa (CCSSA) expedited the development of a triage guidance document to inform the appropriate and fair use of scarce ICU resources during this pandemic. Triage decision-making is based on the clinical odds of a positive ICU outcome, balanced against the risk of mortality and longer-term morbidity affecting quality of life. Factors such as age and comorbid conditions are considered for their potential impact on clinical outcome, but are never the sole criteria for denying ICU-level care. Arbitrary, unfair discrimination is never condoned. The CCSSA COVID-19 triage guideline is aligned with SA law and international ethical standards, and upholds respect for all persons. The Bill of Rights, however, does not mandate the level of care enshrined in the constitutional right to healthcare. ICU admission is not always appropriate, available or feasible for every person suffering critical illness or injury; however, everyone has the right to receive appropriate healthcare at another level. If ICU resources are used for people who do not stand to benefit, this effectively denies others access to potentially life-saving healthcare. Appropriate triaging can therefore be considered a constitutional imperative.

Contact tracing during the COVID-19 pandemic: Protection of personal information in South Africa

Containing the COVID-19 pandemic necessitates the use of personal information without the consent of the person. The protection of personal information is fundamental to the rights that ensure an open and democratic society. When regulations that limit the right to privacy are issued outside of the democratic process, every effort must be made to protect personal information and privacy. The limitation of human rights must be treated as an exception to the norm, and any regulations should be drafted to ensure minimum limitation of rights, rather than to the minimum acceptable standard. The contact tracing regulations included in the COVID-19 disaster regulations include some basic principles to ensure privacy;however, other important principles are not addressed. These include principles of transparency and data security. The envisaged future use of human data for research purposes, albeit de-identified, needs to be addressed by the COVID-19 designated judge appointed under the regulations.