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BACKGROUND: Immune checkpoint inhibitors have transformed the treatment landscape of many cancers, including melanoma and renal cell carcinoma (RCC). Randomised trials are evaluating outcomes from reduced ICI treatment schedules with the aim of improving quality of life, tolerability, and cost-effectiveness. This study aims to provide insight into patient and carer's perspectives of these trials. METHODS: Seven focus groups were conducted with 31 people with stage IV melanoma, RCC, or caregivers for people receiving ICI. Transcripts were analysed using reflexive thematic analysis. RESULTS: Three themes were generated: 1) "Treatment and clinic visits provide reassurance": reducing hospital visits may not improve quality of life. 2) "Assessment of personal risk versus benefit": the decision to participate in an ICI optimisation trial is influenced by treatment response, experience of toxicity and perceived logistical benefits based on the individual's circumstances. 3) "Pre-existing experience and beliefs about how treatment and trials work", including the belief that more treatment is better, influence views around ICI optimisation trials. CONCLUSION: This study provides insight into recruitment challenges and recommends strategies to enhance recruitment for ongoing ICI optimisation trials. These findings will influence the design of future ICI optimisation trials ensuring they are acceptable to patients.
Assuntos
Carcinoma de Células Renais , Inibidores de Checkpoint Imunológico , Qualidade de Vida , Humanos , Inibidores de Checkpoint Imunológico/uso terapêutico , Feminino , Masculino , Pessoa de Meia-Idade , Carcinoma de Células Renais/tratamento farmacológico , Carcinoma de Células Renais/imunologia , Idoso , Adulto , Melanoma/tratamento farmacológico , Melanoma/imunologia , Neoplasias Renais/tratamento farmacológico , Neoplasias Renais/imunologia , Grupos Focais , Pesquisa Qualitativa , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: Skin cancer specialist nurses (SCSNs) support patients and work alongside healthcare professionals throughout the care pathway. Skin cancer management is rapidly evolving, with increasing and more complex treatment options now available, so the need for patient support is growing. While SCSNs are a major source of that support, the provision of SCSN resource across the UK has never previously been assessed. We therefore undertook a first SCSN census on 1st June 2021. METHODS: An electronic survey was disseminated to UK hospital trusts and registered skin cancer healthcare professionals. Responses were identifiable only by the respective trust name. RESULTS: 112 responses from 87 different secondary care trusts were received; 92% of trusts reporting having at least 1 established SCSN post. Average SCSN staffing per trust was 2.4 (range 0-7) whole time equivalents, managing an average caseload of 83 (range 6-400) patients per week. SCSN workload had increased in 82% hospitals in the previous year and 30% of trusts reported being under-resourced. Most SCSN time was spent managing melanoma (as opposed to non-melanoma skin cancer) patients linked to surgical services. Regional variations existed, particularly associated with provision of lymphoedema services, nurse prescribing skills and patient access to clinical trials. The COVID-19 pandemic was associated with a marked increase in SCSN-led telemedicine clinics, but loss of training and education opportunities. CONCLUSIONS: SCSNs based in secondary care hospitals play a major role supporting both clinicians and patients throughout the care pathway. This first UK census confirmed that SCSN workload is increasing and in one third of hospital trusts, the work was reported to outstrip the staffing available to manage the volume of work. Regional variations in SCSN resource, workload and job role, as well as availability of certain skin cancer services were identified, providing valuable information to healthcare commissioners concerned with service improvement.
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Advances in research have transformed the management of melanoma in the past decade. In parallel, patient advocacy has gained traction, and funders are increasingly prioritizing patient and public involvement. Here we discuss the ways in which patients and the public can be engaged in different stages of the research process, from developing, prioritizing and refining the research question to preclinical studies and clinical trials, then finally to ongoing research in the clinic. We discuss the challenges and opportunities that exist at each stage in order to ensure that a representative population of patients and the public contribute to melanoma research both now and in the future.
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Pesquisa Biomédica , Melanoma/terapia , Participação do Paciente , Ensaios Clínicos como Assunto , Humanos , Disseminação de Informação , Consentimento Livre e Esclarecido , Defesa do Paciente , Seleção de Pacientes , Projetos de PesquisaRESUMO
BACKGROUND: Clarity and accuracy of the pharmacy aspects of cancer clinical trial protocols is essential. Inconsistencies and ambiguities in such protocols have the potential to delay research and jeopardise both patient safety and collection of credible data. The Chemotherapy and Pharmacy Advisory Service was established by the UK National Cancer Research Network, currently known as National Institute for Health Research Clinical Research Network, to improve the quality of pharmacy-related content in cancer clinical research protocols. This article reports the scope of Chemotherapy and Pharmacy Advisory Service, its methodology of mandated protocol review and pharmacy-related guidance initiatives and its current impact. METHODS: Over a 6-year period (2008-2013) since the inception of Chemotherapy and Pharmacy Advisory Service, cancer clinical trial protocols were reviewed by the service, prior to implementation at clinical trial sites. A customised Review Checklist was developed and used by a panel of experts to standardise the review process and report back queries and inconsistencies to chief investigators. Based on common queries, a Standard Protocol Template comprising specific guidance on drug-related content and a Pharmacy Manual Template were developed. In addition, a guidance framework was established to address 'ad hoc' pharmacy-related queries. The most common remarks made at protocol review have been summarised and categorised through retrospective analysis. In order to evaluate the impact of the service, chief investigators were asked to respond to queries made at protocol review and make appropriate changes to their protocols. Responses from chief investigators have been collated and acceptance rates determined. RESULTS: A total of 176 protocols were reviewed. The median number of remarks per protocol was 26, of which 20 were deemed clinically relevant and mainly concerned the drug regimen, support medication, frequency and type of monitoring and drug supply aspects. Further analysis revealed that 62% of chief investigators responded to the review. All responses were positive with an overall acceptance rate of 89% of the proposed protocol changes. CONCLUSION: Review of pharmacy content of cancer clinical trial protocols is feasible and exposes many undetected clinically relevant issues that could hinder efficient trial conduct. Our service audit revealed that the majority of suggestions were effectively incorporated in the final protocols. The refinement of existing and development of new pharmacy-related guidance documents by Chemotherapy and Pharmacy Advisory Service might aid in better and safer clinical research.