What is the impact of targeted therapies given within phase I trials on the cognitive function of patients with advanced cancer: a mixed-methods exploratory study conducted in an early clinical trials unit.

INTRODUCTION: Novel therapies such as small protein molecule inhibitors and immunotherapies are tested in early phase trials before moving to later phase trials and ultimately standard practice. A key aim of these clinical trials is to define a toxicity profile, however, the emphasis is often on safety with measurements of organ toxicity. Other subjective side effects can be under-reported because they are not measured formally within the trial protocols. The concern from clinical practice is that cognitive toxicity is poorly studied and may be under-reported in this context. This could lead to toxicity profiles of new treatments not being fully described and patients with unmet need in terms of acknowledgement and support of symptoms. This protocol outlines a framework of an exploratory study with feasibility aspects to investigate the impact and experience of cognitive changes for patients on phase I trials. METHODS AND ANALYSIS: This is a mixed-methods study, combining quantitative and qualitative approaches. The sample is 30 patients with advanced cancer who are participating in phase I trials of novel therapies in the early clinical trials unit of a specialist cancer centre. A test battery of validated cognitive assessments will be taken alongside patient reported outcome measures at three time points from baseline, day eight and day 28 post start of treatment. At day 28, a semi-structured interview will be conducted and the narrative thematically analysed. Results will be integrated to offer a comprehensive description of cognitive function in this patient group. ETHICS AND DISSEMINATION: The study has received full HRA and ethical approval. It is the first study to introduce formal cognitive assessments in a cancer phase I trial context. The study has the potential to highlight previously unreported side effects and more importantly unmet need in terms of care for patients who are participating in the trials.

Parent values and preferences underpinning treatment decision making in poor prognosis childhood cancer: a scoping review protocol.

INTRODUCTION: Parents of a child with cancer want to be involved in making treatment decisions for their child. Underpinning and informing these decisions are parents' individual values and preferences. Parents of a child who has a poor prognosis cancer and who subsequently dies can experience decisional regret. To support parents, and potentially reduce decisional regret, identifying the values and preferences of parents who are making these treatment decisions may enhance the support that can be provided by healthcare professionals. An increased understanding will support future work in this area and identify research gaps that could strengthen support strategies in clinical practice. The aim of this scoping review is to explore parent values and preferences underpinning treatment decision making when their child is receiving cancer-directed therapy for a poor prognosis cancer. METHODS AND ANALYSIS: The Joanna Briggs Institute scoping review methodology will be followed. An initial database search of CINHAL and MEDLINE will be conducted to analyse the keywords using subject headings and Medical Subject Headings terms. Articles will be initially screened on title and abstract. The reference and citation lists of the full-text articles to be included will be searched using Web of Science. Articles will be independently reviewed by two reviewers and any discrepancies discussed with a third reviewer. Data extracted will be presented in tabular, diagrams and descriptive summaries. ETHICS AND DISSEMINATION: Ethical approval is not required for this scoping review. This review will inform further research with parents to understand their values and preferences when making repeated treatment decisions when their child has a poor prognosis cancer. All outputs will be disseminated through peer-reviewed publications and conference presentations.This scoping review is registered on the Open Science Framework (https://osf.io/n7j9f).

Protocol for a multicentre longitudinal mixed-methods study: feeding and survivorship outcomes in previously healthy young paediatric Intensive care survivors (the PIES Study).

INTRODUCTION: An admission to paediatric intensive care unit (PICU) is associated with multiple physical and environmental stressors, often involving many negative and painful oral experiences. Evidence from children with complex medical conditions suggests that feeding difficulties post-PICU stay are common, causing significant parental anxiety. Adult intensive care unit (ICU) survivor studies suggest feeding issues lasting up to 3 months post-discharge from ICU. There is, however, a paucity of evidence regarding feeding outcomes for previously healthy children following a PICU admission and whether painful oral experiences during an admission contribute to feeding difficulties post-discharge, negatively impacting on parental/caregiver anxiety. METHODS AND ANALYSIS: This longitudinal mixed-methods study will explore the impact of feeding difficulties, identifying any clinical risk factors during the first 6 months of PICU discharge in previously healthy young children (≤4 years). Parents/caregivers of children will be asked to complete questionnaires relating to: feeding difficulties, parental/caregiver stress, and child and parental/caregivers' feeding behaviours at the point of PICU discharge, 1, 3 and 6 months post-discharge. Parents/caregivers will be invited to participate in qualitative semistructured interviews at 3 and 6 months post-PICU discharge exploring parental/caregiver experiences of feeding their child after PICU. Statistical analysis of the survey data will consist of descriptive and inferential statistics, plus qualitative analysis of any free text comments using thematic analysis. ETHICS AND DISSEMINATION: This study will provide an insight and increase our understanding of the prevalence of feeding difficulties in previously healthy children admitted to PICU and parental/caregiver experiences. Multiple methods will be used to ensure that the findings are effectively disseminated to service users, clinicians, policy and academic audiences. The study has full ethical approval from the National Health Service Research Ethics Committee (Ref: 20/YH/0160) and full governance clearance.

Perspectives from health, social care and policy stakeholders on the value of a single self-report outcome measure across long-term conditions: a qualitative study.

OBJECTIVES: To explore the views of a range of stakeholders regarding whether patient-reported outcome measures (PROMs) can be developed to measure key attributes of long-term conditions (LTCs) care in England, and the potential value of a single generic measure. DESIGN: Qualitative semistructured interview study, analysed using a framework approach. PARTICIPANTS AND SETTING: Interviews with 31 stakeholders from primary care, secondary care, social care, policy and patient-focused voluntary organisations in England. RESULTS: There was broad support for a single PROM that could be used to measure outcomes for patients with any LTCs in any health or social care setting. Interviewees identified three desired uses for a PROM: to improve the quality of individual care; to increase people's engagement in their own care; and to monitor the performance of services. Interviewees felt that a PROM for LTCs should incorporate a mixture of traditional and non-traditional domains, such as functioning, empowerment and social participation, and be codesigned with patients and professional end-users. Stakeholders emphasised the need for a PROM to be feasible for practical implementation at the individual clinical level as a first priority. A number of concerns and potential problems were identified in relation to the application and interpretation of an LTC PROM. CONCLUSIONS: This study has demonstrated support for a single self-report outcome measure that reflects the priorities of people with LTCs, if such a measure can be shown to be meaningful and useful at the individual level. People with LTCs and professional end-users in health and social care should be involved in the development and evaluation of such a measure.