Lifestyle coaching is feasible in fatigued brain tumor patients: A phase I/feasibility, multi-center, mixed-methods randomized controlled trial

Abstract

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.

Adult brain tumour research in 2024: Status, challenges and recommendations

“…The James Lind Alliance produced a consensus priority list highlighting ‘quality of life’ questions about lifestyle factors, interval scanning, early referral to palliative care, the study of late effects, interventions for carers and strategies for managing fatigue [4]. Numerous routes for grant funding exist: The Brain Tumour Charity's dedicated Quality of Life research grant call funded BT‐LIFE, an innovative UK pilot trial of lifestyle interventions for fatigue that recently published positive results [74] and the NIHR‐funded SPRING, a phase 3 trial of levetiracetam prophylaxis of epilepsy in seizure‐naive patients with newly diagnosed glioma [75].…”

“…questions about lifestyle factors, interval scanning, early referral to palliative care, the study of late effects, interventions for carers and strategies for managing fatigue[4]. Numerous routes for grant funding exist: The Brain Tumour Charity's dedicated Quality of Life research grant call funded BT-LIFE, an innovative UK pilot trial of lifestyle interventions for fatigue that recently published positive results[74] and the NIHR-funded SPRING, a phase 3 trial of levetiracetam prophylaxis of epilepsy in seizure-naive patients with newly diagnosed glioma[75].Notwithstanding these UK initiatives, survivorship and outcomes research received just 5% of total NCRI partner spend on brain tumour research in 2021 (Figure3D), potentially limiting improvements. Increasing proportional spending requires a shift away from low-impact observational studies.…”