ABSTRACT
In our 2020 consensus paper, we devised ten recommendations for conducting Complex Innovative Design (CID) trials to evaluate cancer drugs. Within weeks of its publication, the UK was hit by the first wave of the SARS-CoV-2 pandemic. Large CID trials were prioritised to compare the efficacy of new and repurposed COVID-19 treatments and inform regulatory decisions. The unusual circumstances of the pandemic meant studies such as RECOVERY were opened almost immediately and recruited record numbers of participants. However, trial teams were required to make concessions and adaptations to these studies to ensure recruitment was rapid and broad. As these are relevant to cancer trials that enrol patients with similar risk factors, we have added three new recommendations to our original ten: employing pragmatism such as using focused information sheets and collection of only the most relevant data; minimising negative environmental impacts with paperless systems; and using direct-to-patient communication methods to improve uptake. These recommendations can be applied to all oncology CID trials to improve their inclusivity, uptake and efficiency. Above all, the success of CID studies during the COVID-19 pandemic underscores their efficacy as tools for rapid treatment evaluation.
ABSTRACT
Understanding impact of the coronavirus pandemic (COVID-19) on Adolescents and Young Adults (AYA) with cancer is important to inform care. Online survey of 16-24 year olds receiving cancer treatment at eight cancer centres in the UK. We measured: self-perceived increased anxiety since COVID-19, impact of COVID-19 on treatment, life and relationships, PHQ-8, GAD and the two-item Connor-Davidson Resilience Scale (CD-RISC). 112 AYA participated. 59.8% had previous mental health difficulties. 78.6% reported COVID-19 having a significant impact on life. 79% reported experiencing increased anxiety since COVID-19.43.4% had moderate-severe PHQ-8 scores and 37.1% GADS-7 scores. Impact on life was associated with moderate-severe PHQ-8 scores (OR 5.23, 95% CI 1.65-16.56, p < 0.01), impact on relationships with moderate-severe GADS-7 and PHQ-8 score (OR 2.89, 95% CI 1.11-7.54, p = 0,03; OR 3.54, 95% CI 2.32-15.17, p < 0.01; OR 2.42, 95% CI 1.11-5.25, p =0.03). Greater resilience was associated with lower mod-severe GADS-7and PHQ-8 scores (OR 0.58, 95% CI 0.41-0.81, p < 0.01; OR 0.55 95% CI 0.4-0.72, p < 0.01; OR 0.52, 95% CI 0.38-0.69, p < 0.01). We found high levels of psychological distress. Perceived impact of COVID-19 on relationships and life was predictive of poorer mental health, with resilience a protective factor.
Subject(s)
COVID-19 , Neoplasms , Psychological Distress , Resilience, Psychological , Adolescent , Anxiety , Depression , Humans , Pandemics , SARS-CoV-2 , Young AdultABSTRACT
INTRODUCTION: The primary objective of the ReIMAGINE Prostate Cancer Screening Study is to explore the uptake of an invitation to prostate cancer screening using MRI. METHODS AND ANALYSIS: The ReIMAGINE Prostate Cancer Screening Study is a prospective single-centre feasibility study. Eligible men aged 50-75 years with no prior prostate cancer diagnosis or treatment will be identified through general practitioner practices and randomly selected for invitation. Those invited will be offered an MRI scan and a prostate-specific antigen (PSA) blood test. The screening MRI scan consists of T2-weighted, diffusion-weighted and research-specific sequences, without the use of intravenous contrast agents. Men who screen positive on either MRI or PSA density will be recommended to have standard of care (National Health Service) tests for prostate cancer assessment, which includes multiparametric MRI. The study will assess the acceptability of an MRI-based prostate screening assessment and the prevalence of cancer detected in MRI-screened men. Summary statistics will be used to explore baseline characteristics in relation to acceptance rates and prevalence of cancer. ETHICS AND DISSEMINATION: ReIMAGINE Prostate Cancer Screening is a single-site screening study to assess the feasibility of MRI as a screening tool for prostate cancer. Ethical approval was granted by London-Stanmore Research Ethics Committee Heath Research Authority (reference 19/LO/1129). Study results will be published in peer-reviewed journals after completion of data analysis and used to inform the design of a multicentre screening study in the UK. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04063566).