Title: Cancer: Life Affirming Survivorship support in Primary care (CLASP) Programme
Funder: Department of Health and Social Care

Abstract: Background and Rationale. The UK has 2 million cancer survivors and the prevalence is set to increase, but we have one of the poorest cancer survival records among developed countries and quality of life is poor &ndash; with high levels of distress and fatigue. In contrast there is evidence that both lifestyle and psychological wellbeing interventions are likely to significantly improve quality of life, but most previous interventions have been intensive and impractical to implement in primary care, which is where most contact with patients occurs. It is plausible based on our previous internet supported interventions that relatively resource-light interventions using internet based support in a primary care context are likely to be effective. Aim: To develop and test internet-supported interventions for lifestyle and wellbeing among cancer survivors in primary care. Objectives: To estimate the effectiveness and cost-effectiveness of internet supported combined lifestyle and wellbeing intervention in enhancing quality of life in cancer survivors Research plan WS1 will systematically identify and review key quantitative and qualitative literature to inform theoretical modelling for the intervention, and identify key components of the intervention using an intervention mapping process WS2 will iteratively develop web based materials with qualitative methods for both participants and staff and then perform a feasibility trial among approximately100 participants in 5-10 practices of the initial version of the intervention. Qualitative work will continue during the feasibility trial and final modifications to the interventions and package of outcome measures will be made as necessary following the feasibility trial. WS3 will perform a randomised controlled trial of two interventions compared to a control group among 2500 cancer survivors who have a history of prostate, breast or colon cancer: 1) Control. Brief advice with written materials (control group); 2) Web only. As in 1) but with encouragement to use an internet based Lifestyle and Wellbeing Package 3) Web with flexible nurse support. As in 2) but with additional structured guidance and support in use of the self-help intervention provided flexibly by practice nurses as necessary. WS4 will estimate cost-effectiveness of the interventions trialled in WS3. Dissemination Our findings will be disseminated through: high impact open access journals; professional publications; social media; stakeholder events; through our PPI collaborators; NICE. If cost-effective, we will rapidly disseminate the web-based intervention very widely, at low cost to NHS patients, through appropriate partnerships or licensing arrangements. PPI The PPI input so far has been in developing the protocol &ndash; both key charity stakeholders and also individuals. PPI collaborators are part of the trial management team, have full collaborator status, and will have a role at all stages of the project. Management and Governance A Programme Manager will coordinate the Programme and be in day to day contact with PL and LYar as appropriate. Each WS will be coordinated by a lead or leads (WS1 LYar, WS2 LYar, and for the feasibility trial PL and DE, for WS 3 PL and DE, for WS 4 LYao), and there will be regular team meetings for each WS and for the whole Programme team quarterly. The research will be hosted by Southern Health; the University of Southampton will be the sponsor of the study; the research will be subject to the normal NHS ethics and Research Management and Governance arrangements; and it will be overseen by a PSC and a DMEC as necessary. Benefits to patients and the NHS The Programme has the potential to improve the quality of life among more than 2 million cancer survivors in the UK who currently have significant unmet need and are not well served in the NHS.

Lay abstract: Roughly 2.5 million people in the UK are cancer survivors &ndash; meaning people who have finished primary treatment, whether or not they are cured. The number is rising to an estimated 4 million by 2030. Recent national surveys suggest that 47% of survivors live with either moderately bad or very bad fear of the cancer coming back. Distress is common (37% report anxiety or depression, 31% mood swings), as is fatigue (43%) and sleep problems (43%). Almost 30% take no exercise at all. Studies show that lifestyle changes (healthy eating and more physical activity) and support for improving psychological wellbeing (particularly coping with tiredness and emotional distress) could improve quality of life for cancer survivors. However, we need simple, efficient and effective ways to help, which we could widely and easily put into practice. Our research will explore using the internet as an intervention to support change in the way GP practices offer support to patients. It has several steps: We will review past research to inform how we approach development of the intervention, and to identify particular types of support that have a good chance of working We will then adapt internet applications that have already been developed for patients with other conditions to improve lifestyle (healthy eating and physical activity) and wellbeing (coping with distress and fatigue). The internet applications will be adapted for primary care for patients living with or in remission from colorectal, breast and prostate cancer. We will then carry out a small study of around 100 patients in 5-10 general practices to make sure the intervention is likely to work and be acceptable to patients and health professionals. Following this we will carry out a larger study of 2500 patients. In this study we will randomise patients to one of three groups (so patients will have an equal chance of being in any one of the three groups): 1) Control. Patients will receive brief advice about lifestyle and wellbeing with written materials; 2) Web only. As in (1 above) but with support from a practice nurse to use an Internet based Lifestyle and Wellbeing Package; 3) Web with flexible nurse support. As in (2 above) but with extra guidance and support to increase the likely patient use of the self-help intervention. This will be provided flexibly by practice nurses to participants who request it. We will follow up patients in all groups over 1 year to see if their quality of life improves and to talk to them about what part of the intervention worked well for them and what could have worked better for them.

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