Award Title: ReDMit Study: Co-designing and feasibility testing a behavioural intervention to encourage appropriate symptom REporting and treatment Decision making and MITigate effects of chemotherapy-induced peripheral neuropathy
Funder: Department of Health and Social Care

Abstract: BACKGROUNDChemotherapy-induced peripheral neuropathy (CIPN) refers to peripheral nerve damage caused by neurotoxic chemotherapy agents. CIPN symptomssuch as numbness, tingling, pain, and muscle weaknessare felt mainly on hands and feet. Research show that individuals who reported having CIPN symptoms are three times more likely to have falls or near falls than those who have no CIPN. Patients experience decreased quality of life (QOL) due to lifestyle changes, reduced participation in social activities, and difficulty performing work duties leading to financial losses. There is no effective treatment and prevention for CIPN; to avoid or lessen the seriousness, chemotherapy doses may need to be delayed, reduced or discontinued. It is estimated that of 100 people treated with nerve-damaging cancer drugs, 30 will continue to have symptoms six months or longer after treatment. Because more and more people survive cancer, the number of people living with CIPN will increase year-on-year. The cost burden of CIPN to the NHS will be considerably higher, as will patient and carer economic losses. RESEARCH QUESTIONIs a co-designed behavioural intervention that aims to encourage appropriate symptom reporting and treatment decision making and mitigates effects of chemotherapy-induced peripheral neuropathy acceptable to patients, and would a definitive trial of its effectiveness be feasible to conduct? PLAN OF INVESTIGATION The study is informed by the Medical Research Council Framework on developing and evaluating complex interventions and is divided into three phases.Phase 1 will involve systematic review of studies which explored available interventions for managing the consequences of peripheral neuropathy in cancer and other conditions. Additionally, an empirical analysis of a CIPN dataset from the European FP7 funded eSMART study (n=1100) will be carried out to better understand the natural history of CIPN.The study design draws upon the Common Sense Model of Self-regulation of Health and Illness which will underpin the development of the intervention and identify the essential elements of its components. Phase 2 will involve non-participant observation of chemotherapy consultations before, halfway and at the end of chemotherapy treatment (n=12), semi-structured interviews with patients (n=12) and healthcare professionals (n=12). The theory and empirical evidence gathered during chemotherapy consultation observations and interviews will inform the intervention co-design process using an established approach (Experience-Based Co-Design). Findings will be used to initiate and inform discussion about the intervention.It is likely the intervention will consist of:One-to-one factual information provision about CIPN pre-chemotherapyCIPN screening tool for HCPsAdapted decision making tool Phase 3 comprises a feasibility randomised controlled trial with an embedded qualitative process evaluation. A feasibility RCT design has been chosen to estimate important parameters necessary to design the main efficacy study, usually a costly and time-intensive large scale RCT. DISSEMINATION Patients, clinicians, and other members of the public will be made aware of the results through papers published in journals, presentations at conferences, public engagement, educational and charity events; distribution will be made using social media.

Lay Abstract: AIMS This study aims to develop and test an intervention that will encourage patients to report symptoms early and make treatment decisions to minimise the effects of chemotherapy-induced peripheral neuropathy (CIPN).BACKGROUND Some cancer drugs cause damage to nerves, a condition called CIPN. The most common symptoms, felt mainly in the hands and feet, are numbness, tingling, pain, muscle weakness, and/or sensitivity to cold. People with CIPN can have functional difficulties in carrying out tasks involving their hands and feet. Studies show that individuals who reported having CIPN symptoms are three times more likely to have falls or near-falls than those who did not. Symptoms result in decreased quality of life due to lifestyle changes, reduced participation in social activities, and difficulty carrying out work duties, leading to financial loss. It is estimated that, of 100 people treated with nerve-damaging cancer drugs, 30 will continue to have symptoms six months or longer after treatment. There is no effective treatment or prevention for CIPN; to avoid or lessen the seriousness, chemotherapy doses may need to be delayed, reduced or discontinued.It is important to prepare patients about the possibility of developing CIPN, to help them recognise and report symptoms early. It is also vital that patients are involved in making decisions when chemotherapy doses are modified to allow symptoms to settle, and help patients to adopt management strategies to mitigate the effects of CIPN on their daily activities.WHAT WILL THE STUDY INVOLVE? Phase 1 Preliminary studies will be conducted to explore available interventions for managing the consequences of nerve damage. Analysis of data from a European study, where 1100 patients reported CIPN symptoms daily, will be carried out to help increase our understanding of CIPN occurrence, severity and recovery.Phase 2a Using an approach called Experience-Based Co-Design (EBCD), patients and healthcare professionals (HCPs) will come together to develop the intervention. This will involve: Observations of patient/HCP consultations: before, halfway through, and at the end of chemotherapy treatment will be conducted to find out more about how CIPN information is currently discussed.Interviews: all patients and HCPs observed will be invited for interviews to learn more about their experiences. The patient interviews will be filmed (with consent).Phase 2b Co-design meetings: all participants in the observations and interviews above will be invited to facilitated meetings. Data from Phase 1 and 2a will be used in co-designing the intervention. Findings will be presented through an edited version of the patient film. Participants will then share and discuss views on the intervention. After the meetings, smaller group work will further refine the intervention.Phase 3 The intervention will be then tested on 40 patients who are at risk of developing CIPN. Using a process called randomisation, a computer will allocate 20 patients to receive the intervention, while 20 patients will receive standard care for CIPN. By doing this, we will find out if the intervention is acceptable to patients, and if a larger study is needed to test its efficacy.It is likely the intervention will consist of:One-to-one factual information provision pre-chemotherapyA CIPN screening tool for HCPsAn adapted decision-making tool PATIENT AND PUBLIC INVOLVEMENT Patients and cancer survivors have been involved in discussions about the study's relevance and usefulness, its design, and this grant application. A study-specific patient advisory group has been formed and will be involved in study management, patient materials' development, data analysis and dissemination. DISSEMINATION Patients, clinicians, and other members of the public will be made aware of the results through journal publication,conference presentations, public engagement activities, educational and charity events; and via social media.

Research Activity Codes: 7.1 INDIVIDUAL CARE NEEDS
Health Categories: CANCER AND NEOPLASMS