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BACKGROUND There are no effective treatments for brain tumor-related fatigue. We studied the feasibility of two novel lifestyle coaching interventions in fatigued brain tumor patients. METHODS This Phase I / feasibility multi-center RCT recruited patients with a clinically stable primary brain tumor and significant fatigue (mean Brief Fatigue Inventory [BFI] score ≥ 4/10). Participants were randomized in a 1-1-1 allocation ratio to: Control (usual care); Health Coaching (“HC”, an eight-week program targeting lifestyle behaviors); or HC plus Activation Coaching (“HC+AC”, further targeting self-efficacy). The primary outcome was feasibility of recruitment and retention. Secondary outcomes were intervention acceptability, which was evaluated via qualitative interview, and safety. Exploratory quantitative outcomes were measured at baseline (T0), post-interventions (T1, 10 weeks), and endpoint (T2, 16 weeks). RESULTS N=46 fatigued brain tumor patients (T0 BFI mean=6.8/10) were recruited and 34 were retained to endpoint, establishing feasibility. Engagement with interventions was sustained over time. Qualitative interviews (n=21) suggested that coaching interventions were broadly acceptable, although mediated by participant outlook and prior lifestyle. Coaching led to significant improvements in fatigue (improvement in BFI versus control at T1: HC=2.2 points [95%CI 0.6,3.8], HC+AC=1.8 [0.1,3.4], Cohen’s d [HC]=1.9; improvement in FACIT-Fatigue: HC=4.8 points [-3.7,13.3]; HC+AC=12 [3.5,20.5], d [HC&AC]=0.9). Coaching also improved depressive and mental health outcomes. Modelling suggested a potential limiting effect of higher baseline depressive symptoms. CONCLUSIONS Lifestyle coaching interventions are feasible to deliver to fatigued brain tumor patients. They were manageable, acceptable, and safe, with preliminary evidence of benefit on fatigue and mental health outcomes. Larger trials of efficacy are justified.

BACKGROUND Fatigue is common and disabling for brain tumour patients. We studied the feasibility of two innovative lifestyle coaching interventions for high fatigue. METHODS Multi-centre phase II feasibility RCT (ISRCTN17883425). Adult primary brain tumour outpatients reporting significant fatigue (Brief Fatigue Inventory [BFI] score 4+), were randomised to one of three arms: Control; Health Coaching (“HC”, comprising eight structured coaching sessions on lifestyle behaviours); or HC plus Activation Coaching (“HC+AC”, adding two structured interviews targeting motivation to change). Outcomes were measured at baseline (T0), after interventions (T1), and at 16 weeks (T2). The primary outcome of feasibility was required for both recruitment (aim: average n= 5 fatigued patients recruited/month) and retention (aim: minimum 60% retention at T2). Secondary pilot outcomes included change in fatigue, depressive symptom, and QOL measures. RESULTS Over a nine-month recruitment period, n= 46 fatigued brain tumour patients were recruited (average n=5.1/month) and n= 34 were retained to endpoint (retention at T2= 73%), meeting the primary outcome of feasibility. Surprisingly, fatigue reduced significantly after HC (T1 mean change in BFI score from T0 baseline, relative to the equivalent change in control group: HC= -2.3 points [95%CI -3.4/-0.3]; HC+AC= -2.0 [-2.9/+0.1]; ANOVA p= 0.02) and was reduced in magnitude in both intervention groups at T2 (p= N.S). Both interventions also improved depressive symptoms (T1 mean change in HADS-Depression: HC= -2.0 points [-5.6/-0.1]; HC+AC= -2.9 [-6.5/-1.0]; Kruskal-Wallis p= 0.02). Patient-nominated QOL outcomes improved persistently after HC+AC (T2 mean change in PSYCHLOPS score: HC= -2.4 points [-5.4/+2.8]; HC+AC= -6.1 [-9.2/-0.8]; ANOVA p= 0.01). CONCLUSION Innovative coaching interventions, focused on lifestyle factors, are feasible to deliver to fatigued brain tumour patients. Preliminary signals suggest that these non-drug approaches may benefit several mediators of quality of life and warrant further study.

Background In 2008, the National Cancer Action team started a cancer rehabilitation workforce scoping exercise. As a result of this, eight cancer disease group rehabilitation pathways and four symptom specific pathways were published in 2010. The pathways were written following all available evidence and examples of best practice, where evidence was not available. (National Cancer Action Team; Briefing Paper 2 CRWP September 2008) As part of our role we were given the task of introducing the Brain and CNS rehab pathway to our local cancer network (Greater Manchester and Cheshire Cancer Network). We were required to localise the pathway and examine how closely the rehab provided for the brain and CNS tumour patients was following the suggested ‘best practice’ in the rehab pathway. We had assistance of the local Supra District Audit office to audit the existing pathway and rehabilitation interventions prior to our input, and re audit following a year of education and promotion of the pathway. Aim of the presentation The aim of the poster is to detail the processes that led to the production of a successful audit tool, and to discuss the ‘trials and tribulations’ of carrying out a regional audit of patient notes which spanned numerous separate agencies. We aim to make others aware of some of the pitfalls surrounding multi agency audit. Methodology A retrospective audit of medical/allied health professional notes was carried out on a sample of randomly selected patients diagnosed with a primary brain or spinal tumour within a specified period. All agencies involved have been made aware of the audit and each individual Information Governance Team has had to give approval. As the audit did not involve discussion with patients, ethical approval was not required.

BACKGROUND BT-LIFE is a multi-centre RCT of novel lifestyle coaching treatments for fatigued brain tumour patients. To our knowledge it is also the first example of ‘multi-sectoral research’ to combine healthcare, private, and charity sectors in this population. To maximise learning, the trial team devised a structured reflection opportunity to ask, “What went well and what would we do differently next time?” METHOD After trial closedown we convened a six-hour ‘focus group’ for management, principle investigators, research assistants, interventionists, qualitative researchers, trial statisticians, and the funder. Discussion was structured using a ‘timeline’ wall-chart which attendees freely populated with post-it notes summarising learning points from the trial. Minutes were taken in duplicate. RESULTS In total n=19 team members contributed. Many points were study-specific and will be used internally to plan a larger trial. Among points of wider interest, examples of success included: using regular teleconferences to co-ordinate a cohesive and highly collaborative team; obtaining secure nhs.net email addresses to facilitate multi-sectoral communication; and the clear value of employing one part-time research assistant per centre instead of relying on busy clinical staff to recruit. General future learning points included: speak to the prospective sponsor and ethical committees when writing the grant application to avoid pitfalls and facilitate faster opening if funding is secured; consider preceding emails with a phone call to ‘lay the ground’ in time-sensitive situations; identify staff training requirements as early as possible and cascade aggressively; and be sensitive to the fact that inter-sectoral attitudes and practices may vary widely and need actively monitored and managed. Therefore frequent and secure communication, pro-active problem-spotting, and inter-sectoral value alignment appear critical for success. CONCLUSION BT-LIFE provides many useful lessons for anyone interested in running multi-sectoral research.