Cancer: Life Affirming Survivorship support in Primary care (CLASP) Programme

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 – 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 – 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.