Title: Developing a short-term integrated rehabilitation service for people with newly diagnosed thoracic cancer
Funder: Health Education England

Abstract: RATIONALE: Lung cancer is the 2nd most common cancer in the UK, with 40,000 new diagnoses each year. Patients experience a high symptom burden, which impacts adversely on treatment tolerability, daily activities, levels of independence and overall quality of life. A rehabilitation approach is recommended to help maximise function and promote independence. Despite national policy, patients face difficulties accessing existing services. Most involve intensive, supervised exercise programmes (over 8-20 weeks) and are only acceptable to a minority of patients. A short-term and integrated approach offered around the time of diagnosis should enable more patients to access rehabilitation. It would provide proactive support to help patients remain independent through self-management, enable continuity of rehabilitation provision by the main care provider, and fit within a specialist service remit to support patients directly at times of need and indirectly through education and support of other professionals.AIMS: To develop and test the feasibility of a short-term, integrated rehabilitation service for people with newly diagnosed thoracic cancer. OBJECTVIES: Phase I (development and modeling): identify the active components of a new service; refine service delivery and outcomes. Phase II (feasibility testing): determine feasibility of the service as an intervention; understand experiences of service receipt and integrated working; explore the impact of the service on symptom burden, function and health service use. PHASE I: DEVELOPMENT & MODELLING Literature scoping: Reviews following PRISMA guidelines to aid development of the underpinning theoretical model for the service, based around behaviour change models, and to identify the evidence-base for appropriate interventions for patient sub-groups. Searches will include electronic databases and grey literature searching using MeSH terms to include: rehabilitation, exercise, self-management and thoracic, lung cancer or mesothelioma. Focus groups: Two focus groups of 12-15 patients, families / caregivers, PPI representatives and patient bodies, then 12-15 health and social care professionals, to inform and refine enrolment procedures, core components of the intervention, delivery and working practices, key process and outcome measures. Participants will consider a pre-meeting task and discuss the service model and literature review findings to build consensus recommendations for the feasibility trial. PHASE II: FEASIBILITY TESTING Design: Parallel group, randomised, controlled multicentre feasibility trial. Patients will be randomised at the individual level with a 1:1 allocation to either the short-term integrated rehabilitation service or standard NHS care over 30 days. Population: 60 adults diagnosed with thoracic cancer, ECOG performance status 0-3 and prognosis of >1 month not currently receiving specialist rehabilitation. Intervention: Short-term integrated rehabilitation delivered over three contacts by an allied health professional working to a manual and with other professionals, e.g. oncologists, nurse specialists. Key intervention components include: checking concerns and treatment goals; functional assessment, e.g. limiting symptoms, avoidance behaviours, education to enhance health behaviours, help to self-manage, an action plan shared with others, and referrals to local services Control: standard NHS care, which can include nurse specialist contacts throughout the patient pathway, with generally limited advice on maintaining function. Feasibility outcomes: Number of patients screened for eligibility, proportion of eligible patients randomised and remaining in the trial for 30 days, proportion of and reasons for patients with missing data for trial outcomes, level of intervention fidelity, proportion of patients for which blinding is maintained, and number of referrals to local rehabilitation services. A questionnaire survey will investigate patients and health care professionals' experiences of the trial. Clinical outcomes: 30 and 60 days post-randomization using patient reported measures including: Integrated Palliative Care Outcome Scale, Physical Activity Scale for the Elderly, Functional Independence Measure and Functional Assessment Measure, General Self-Efficacy, Trial Outcome Index and health and social care services use recorded on a Client Services Receipt Inventory.

Lay abstract: At any one time, over 65,000 people are alive in the UK having been given a lung cancer diagnosis. The condition and its medical treatment (with chemotherapy, radiotherapy and surgery) cause many symptoms that affect day-to-day life. These include breathlessness, weakness and tiredness or fatigue. Rehabilitation treatments can help to relieve these symptoms and can help people to stay active and independent whilst living with lung cancer. Most research studies to date have offered rehabilitation in the form of supervised exercise programmes. These involve vigorous physical training, over several months, and often take place in a hospital setting, so require a lot of commitment from the person with cancer. Many people do not feel able to take part in these intensive programmes and miss out on rehabilitation. The aim of this project is to develop and then test a different form of rehabilitation service, which may help more people to access and benefit from rehabilitation. The service will use existing staff, such as physiotherapists. It will be offered close to the time when people are diagnosed to help them prepare for medical treatments and stay active. It will be short-term so the person can benefit from advice and education quickly and does not have to sign up to a long programme. It will also include the health professions providing care for the person with cancer, such as their cancer doctor or nurse. There are two main parts to the project. First, we will develop the service. We will review past studies to learn about the best rehabilitation treatments and how they can most effectively be delivered to people with cancer. We will also hold focus groups' where people affected by cancer, their families, and health professionals come together to discuss how best the service can meet their needs. Second, we will test the new service in a research study. 60 people recently diagnosed with lung cancer will be randomly allocated, i.e. by chance, to receive the rehabilitation service or usual care. People allocated to receive the service will have three contacts with a physiotherapist. These will be to discuss symptom and problems that are limiting their daily living, to learn about ways to self-manage these, and to develop an action plan to encourage good health behaviors, such as staying active by pacing daily tasks. We will measure markers of how well the research study went, including how many people took part, their experiences of the research and the extent to which people receive the care they were allocated to. We will also measure symptom distress, physical activity levels, functional ability and quality of life before and after the service (or usual care). Patient representatives have been involved in the design of the project. They will also be involved in developing information sheets for the study and will help us to present the findings from the studies. The findings from this project will help us to decide if this new rehabilitation service is worth pursuing further and will tell us which parts of the service work well and which do not.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: CANCER AND NEOPLASMS