Title: FRAilty-informed cancer ManagEment (FRAME): Integrating frailty assessment within specialist cancer services to support shared treatment decision-making for those with advanced cancer
Funder: Department of Health and Social Care

Abstract: Research question How can frailty assessment be embedded within specialist cancer services to support shared treatment decision-making and whole-person care for those with advanced cancer? Background With an ageing population, the number of people living with cancer and frailty is increasing. Frailty is a condition characterised by loss of biological reserves, leading to increased vulnerability to external stressors, such as Systemic Anti-Cancer Therapies (SACT) used to control cancer. SACT are associated with significant toxicities and burdens, particularly for patients living with frailty. Therefore, careful assessment and decision-making around suitability for SACT is key. A number of simple tools exist which could be used to assess frailty and inform decision-making discussions in the oncology clinic. In 2018, five Specialised Clinical Frailty Network Cancer Pilot (SCFN-CP) sites began piloting implementation of one such tool, the Clinical Frailty Scale (CFS). This Fellowship will build and expand upon SCFN-CP work. Aims The research is divided into two workstreams (WS1-2): WS1: Understanding existing evidence and current practice Review how simple frailty assessment tools predict cancer outcomes (survival/treatment effectiveness/quality-of-life) Explore how simple frailty assessments are currently being applied and are impacting care at SCFN-CPsWS2: FRAilty-informed cancer ManagEment (FRAME) Complex Intervention development and feasibility testing Co-design the FRAME intervention, with key stakeholders (and informed by WS1), to support the use of frailty assessment within shared treatment decision-making for patients with advanced cancer in the oncology clinic Undertake feasibility testing of the FRAME intervention to: explore intervention acceptability and feasibility identify areas for intervention refinement clarify areas of methodological uncertainty to inform a future pilot and definitive trial (e.g. recruitment and data collection procedures). MethodsIn WS1, existing evidence will be synthesised and new knowledge generated regarding the implementation and added value of frailty assessment in specialist cancer services via a mix-of-methods, including: Systematic review and meta-analysis of existing evidence regarding performance of simple frailty assessment tools for predicting cancer outcomes, to establish candidate frailty assessment tools Mapping exercise and in-depth qualitative interview study exploring stakeholder (patient/carer/staff) experiences of frailty assessment within SCFN-CPs, and impacts on shared treatment decision-making and patient careIn WS2, the FRAME intervention will be co-designed with key stakeholders and tested via a staged approach consistent with MRC guidance for developing and evaluating complex interventions (2021). Feasibility testing will involve a non-randomised, single-arm feasibility study and mixed-method process evaluation, with nested qualitative interviews with patients and staff. This will explore intervention acceptability, feasibility and fidelity, allow intervention refinement and clarify areas of methodological uncertainty to inform a definitive trial. Anticipated impact and dissemination This Fellowship will champion the widespread implementation of frailty assessment to support shared cancer treatment decision-making. Findings will be disseminated to those involved and interested in the care of patients with frailty and cancer via a multi-pronged approach including academic publications, conference presentations and public dissemination via patient/charitable organisations. Linkage with the SCFN, Joint Collegiate Council for Oncology and international research groups will support widespread adoption of findings from this and future research, maximising potential for impact.

Lay abstract: Aim of the research To develop a FRAilty-informed cancer ManagEment (FRAME) intervention to support shared treatment decision-making for patients with advanced cancer Why is this research important? With an ageing population, the number of older people living with cancer and frailty is increasing. Frailty is a term used to describe a person's reduced ability to overcome stresses on the body, and cancer treatments such as chemotherapy can be one such stress. Chemotherapy can cause side-effects and complications which can impact on a persons' quality-of-life. Patients with frailty are more likely to experience significant problems. With this in mind, weighing the benefits and risks, and making decisions about cancer treatment options can be particularly difficult for patients living with frailty and those who care for them. Frailty can be assessed (measured) with a number of tools, which could be used to help to guide cancer treatment decision-making. The 'gold-standard' (best tool available) for assessing frailty is the geriatric assessment. However, geriatric assessments generally require referral to a geriatric medicine specialist which can be time-consuming, burdensome for patients and costly. There are simpler tools which could be used to assess frailty within cancer care, but these are not used routinely. What will this research involve? This fellowship will start by summarising existing research about the relationship between simple frailty assessments and cancer treatment outcomes. It will look in detail at how simple frailty assessments can be used within cancer care, with a key focus on how they can support shared cancer treatment decision-making between patients and healthcare professionals. The UK Specialised Clinical Frailty Network (SCFN) has been testing the use of simple frailty assessments in cancer services through a number of pilots across the country since 2018. We will learn from their experiences by conducting interviews with patients/carers and staff at three pilot sites to find out: 1) whether frailty assessment is acceptable to them 2) how it is being used 3) what impact it is having on patient care. We will then work with key stakeholders (patient representatives/carers/healthcare staff/researchers) to develop a 'FRAilty-informed cancer ManagEment (FRAME) intervention, guided by earlier research findings. The intervention will aim to support shared treatment decision-making between patients with advanced cancer and those that care for them. Based on preparatory work, we anticipate the intervention will involve staff being trained on how to assess frailty better and how to improve discussions with patients when planning cancer treatments such as chemotherapy; alongside materials to support patient/carer information needs. The intervention will be tested in clinic with a small group of patients and staff. Routinely collected data, questionnaires and interviews will find out: 1) if FRAME is acceptable to patients/staff 2) whether FRAME can be successfully used in day-to-day practice 3) how to conduct a larger future study to test whether it works. How are patients involved in developing the research? A Patient and Public Involvement (PPI) advisory group of patients and carers with personal experience of cancer and frailty was formed to shape this fellowship proposal. Early PPI discussions confirmed the need for simple frailty assessments that are able to both support decision-making and improve care, without too much inconvenience to patients. The established PPI group have co-produced the plan for providing ongoing PPI throughout the research. How will research findings be shared? The findings will be shared widely with those who are interested or involved in the care of older and/or frail patients with cancer. This will include via academic publications, conferences, and patient groups/charitable organisations (identified by PPI contributors). The SCFN will also provide a platform for sharing findings with specialist services across the NHS.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;7.3 MANAGEMENT AND DECISION MAKING
Health categories: CANCER AND NEOPLASMS