Grant title: A phase II single-arm feasibility study of telehealth group cognitive behavioural therapy for insomnia (CBT-I) in adults with primary brain tumours using a novel online platform for a stepped clinical pathway for sleep disturbance
Institution: University of Sydney
Grant awarded: September 2025
We are grateful to Wereld Kanker Onderzoek Fonds and World Cancer Research Fund International for enabling this pioneering project to progress. This sleep trial in people with primary brain tumour in Australia marks a critical step towards advancing access to tailored, effective care for this vulnerable and underrepresented group. The funding is instrumental in laying the foundation for a world-first stepped care model that could transform sleep support for these patients – Dr Megan Jeon
Background
One in two people living with primary brain tumour (a tumour originating in the brain) experience poor sleep, such as trouble sleeping at night, excessive sleepiness or disrupted sleep-wake patterns. Sleep disturbances impact immune response, fatigue, mood and cognitive functioning, which could make it harder for people living with primary brain tumour to manage their existing functional challenges.
However, sleep disturbances remain untreated during and after their cancer treatment, due to the lack of screening and effective management options safe for this population. They can be identified early using an online tool (ADAPT BRAINS) that tracks symptoms and guides people living with primary brain tumour to appropriate support. The first-line treatment shown to improve sleep in many cancer patients is cognitive behavioural therapy for insomnia (CBT-I), which has not yet been tested in people living with primary brain tumour in Australia.
Hypothesis and objectives
In this 12-month pilot project, we aim to evaluate whether a 6-week telehealth group CBT-I programme can be safely delivered to people living with primary brain tumour in Australia and explore participants’ experiences with the intervention. We also aim to assess the feasibility of the study design, including processes for screening, assessment, data collection, participant retention, and usability of the ADAPT BRAINS portal. This will then inform the development of a larger trial to test effectiveness. The secondary objectives are to assess severity of sleep disturbance and show preliminary data on the potential benefits of telehealth group CBT-I for people living with primary brain tumour.
We expect that CBT-I will be feasible, acceptable and safe to deliver via a telehealth group format in people living with primary brain tumour in Australia.
How it will be done
We will recruit 120 adults with primary brain tumours around Australia. Participants will complete screening on the ADAPT BRAINS portal. Those who do not report sleep disturbance will receive treatment as usual and complete a one-off study questionnaire on sleep and related symptoms, and quality of life. People who report sleep disturbances will be invited to participate in a 60-minute weekly telehealth group CBT-I programme. Those unwilling or unfit to complete telehealth group CBT-I will receive a self-guided CBT-I booklet on sleep-promoting strategies. They will be encouraged to complete the booklet over 6 weeks with 2 support phone calls to assist their completion.
We will assess the following outcomes at the beginning and after the intervention: self-reported sleep quality, sleep patterns and disturbances measured using actigraphy (a non-invasive monitor of sleep-wake patterns), comorbidities, quality of life and adverse events. We will also collect data to monitor if the study setup works throughout the study. Participants will complete questionnaires and exit interviews to provide feedback on the programme after the intervention.
Potential impact
This research is the first trial to test a stepped clinical pathway (staged approach to patient care) for sleep disturbance in people living with primary brain tumour worldwide. It will create a practical way to screen for sleep issues and test multiple treatment options, making it easier for those living with primary brain tumour to access evidence-based care. So far, these patients have not been included in clinical trials or given suitable treatment for sleep disturbance.
This study will provide important information on whether CBT-I, the gold standard non-pharmacological treatment, is practical, acceptable and safe for this vulnerable and understudied group. The results will help shape larger, future trials to test how well CBT-I works.