Significant advances in systemic therapy have improved survival for patients with advanced-stage non-small cell lung cancer (NSCLC). However, the present treatment strategies and dose-fractionation for high-dose palliative radiotherapy (RT) are based on trials from the 1990s, when RT planning was simple with less precise delivery. Contemporary lung RT uses 4D-CT, volumetric modulated arc radiotherapy, aided by online verification using cone beam CT, which enables greater accuracy and better target volume coverage, while reducing doses to normal organs at risk. The Shortened High-dose Palliative Radiotherapy for Lung Cancer study aims to evaluate the safety and feasibility of reducing the number of RT fractions and RT duration, using contemporary planning, verification and delivery techniques.

This single-arm, multicentre, phase-II study will test the shortened hypofractionated accelerated palliative RT regimen of 30 Gy in 6 alternate-day fractions, with strict normal tissue dose constraints. We aim to recruit 37 patients across 4 sites within the West Midlands. Quality assurance for the RT is supported by the Radiotherapy Trials Quality Assurance Group (RTTQA). Patients with locally advanced or metastatic NSCLC, who are candidates for high-dose palliative RT, before or after first-line systemic therapy, are eligible for recruitment. The primary objective of this study is to assess the safety of the proposed dose-fractionation. Secondary objectives include evaluating toxicity profiles, patient-reported outcome measures, time to progression, feasibility and the National Health Service cost-saving.

This study is conducted in accordance with the International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines and all applicable regulatory frameworks, including, but not limited to, the UK policy framework for health and social care research, as well as the Health Research Authority and Health and Care Research Wales regulations. Approval for the study was granted on 18 April 2024 (IRAS project ID: 332998; REC reference: 24/WM/0032). The chief investigator is responsible for obtaining informed consent from participants. Any individual delegated this responsibility is thoroughly authorised, trained and competent to conduct the informed consent process. On completion of the trial, the results will be shared with participants in a plain language summary and will be submitted for publication in a peer-reviewed journal. If successful, this study will inform a phase III randomised controlled trial to assess efficacy. For updates on the study, visit the study web page (https://research.mededcoventry.org/About-Us/Meet-The-Team/TMU/Ship-Rt).

NCT06483308.

Children with upper limb loss or difference (ULLD) require individualised and developmentally appropriate clinical care. To guide this specialised care, outcome measures can be used to assess important constructs, such as physical function, health-related quality of life (HRQoL) and satisfaction with medical treatments and services. However, there is limited research available on which outcome measures are used to assess these constructs and whether they have been psychometrically assessed in children with ULLD who may or may not use a prosthesis. Thus, the purpose of this scoping review is (1) to determine which outcome measures are used to assess physical function, HRQoL and satisfaction in paediatric patients with ULLD and (2) to identify articles that include children with ULLD in psychometric assessments of these outcome measures. Findings of these studies will be reported. This review will inform healthcare professionals on which outcome measures assessing function, HRQoL and satisfaction have been psychometrically tested for use in children with ULLD. It will also inform future research on outcome measurement in this population.

A two-phase scoping review will be conducted in which PubMed, Web of Science and CINAHL will be searched: first, to identify which outcome measures are used to assess physical function, HRQoL and satisfaction in children with ULLD and, second, to determine whether those measures have been psychometrically assessed for use in this population. Teams of two reviewers will review articles for eligibility and extract information from eligible articles. Tie-breaking will be conducted by a third reviewer. Narrative summaries will be used to describe the findings of this scoping review.

No ethical approval is needed. The results of the review will be submitted for publication in a peer-reviewed journal and presented at relevant conferences.

The scoping review that applies this protocol has been registered on Open Science Framework (https://doi.org/10.17605/OSF.IO/7UGWB).