Brain Neoplasms, Glioblastoma, Primary Brain Tumour
Conditions
Keywords
Occupational Therapy, Symptom Management, Brain Cancer, Neuro-Oncology, Supportive Care, Rehabilitation, Health Related Quality of Life, FACT-BR
Brief summary
People diagnosed with primary brain tumours often experience significant symptoms such as fatigue, cognitive changes, anxiety, and reduced ability to carry out everyday activities. These symptoms may be related to the tumour itself or to ongoing systemic anti-cancer treatment. In Ireland, access to structured rehabilitation and symptom management programmes for this population is limited. The OT SMILE study is evaluating whether a structured occupational therapy-led group programme can improve quality of life and daily functioning in adults with primary brain tumours receiving active treatment. Participants attending Beaumont Hospital who meet eligibility criteria and provide informed consent will be randomly assigned (like flipping a coin) to one of two groups: A six-week occupational therapy group programme (OT SMILE), or Usual care, consisting of written lifestyle management information. The OT SMILE programme consists of six weekly 90-minute group sessions delivered by occupational therapists. Sessions focus on fatigue management, activity modification, cognitive strategies, relaxation techniques, goal setting, exercise, nutrition, and peer support. Participants in both groups will complete questionnaires before the programme begins and again after six weeks. These questionnaires measure quality of life, fatigue, and daily functioning. The main goal of the study is to determine whether the occupational therapy group programme improves health-related quality of life compared to usual care. The results may help inform supportive care services for people living with primary brain tumours.
Detailed description
Background and Rationale Primary brain tumour patients frequently experience substantial symptom burden, including fatigue, cognitive dysfunction, neurological deficits, emotional distress, and reduced participation in activities of daily living. These symptoms may arise from tumour-related pathology, surgical intervention, radiotherapy, chemotherapy, or systemic anti-cancer treatment (SACT). Functional decline significantly impacts independence and health-related quality of life. Although rehabilitation interventions have demonstrated benefits in broader oncology populations, there is limited evidence specifically addressing structured occupational therapy (OT)-led group interventions for patients with primary brain tumours, particularly in an Irish healthcare setting. Occupational therapy focuses on enabling participation in meaningful daily activities through structured goal setting, fatigue management strategies, activity modification, cognitive compensation techniques, and behavioural self-management approaches. Group-based interventions may provide additional benefits including peer support, shared problem-solving, and enhanced motivation. The OT SMILE study is designed to evaluate the effectiveness of a structured OT-led group intervention in improving health-related quality of life and symptom management among outpatients with primary brain tumours undergoing active systemic treatment. Study Design This is a single-centre, prospective, open-label, parallel-group randomised controlled trial conducted at Beaumont Hospital. Participants will be randomised in a 1:1 ratio to either: OT SMILE intervention group Usual care control group Randomisation will be computer-generated by an independent researcher not involved in recruitment or intervention delivery. Due to the behavioural nature of the intervention, blinding of participants and therapists is not feasible. Intervention The OT SMILE programme consists of six weekly group sessions, each lasting approximately 90 minutes, delivered by registered occupational therapists. Groups will include approximately 6-8 participants per cohort. Session components include: Education regarding common symptoms in primary brain tumour patients Fatigue management strategies Goal setting and activity pacing Relaxation techniques Cognitive strategies to support daily functioning Exercise and physical activity guidance Nutrition education Peer support and shared problem-solving Strategies for habit formation and long-term self-management Participants in the control group will receive standard written lifestyle management information and continue usual oncology care. Outcome Assessment Outcome measures will be collected at baseline and at completion of the six-week intervention period. The primary outcome is change in health-related quality of life measured using the Functional Assessment of Cancer Therapy - Brain (FACT-BR). Secondary outcomes include fatigue severity (Brief Fatigue Inventory) and health utility/quality of life (EQ-5D-5L). Occupational performance and satisfaction (Canadian Occupational Performance Measure) will also be assessed in the intervention group.
Interventions
OTHERStandard Lifestyle Management Literature
Provision of written educational materials addressing symptom management, fatigue, activity pacing, and lifestyle strategies. Participants continue routine oncology care without structured occupational therapy group sessions.
BEHAVIORALOT SMILE Occupational Therapy Group Programme
A structured six-week group-based occupational therapy programme delivered by registered occupational therapists. Sessions include fatigue management strategies, goal setting, activity pacing, cognitive strategies, relaxation techniques, exercise guidance, nutrition education, peer support, and strategies to support long-term self-management. Each session lasts approximately 90 minutes and is delivered weekly.
Sponsors
Royal College of Surgeons, Ireland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Blinding of participants and therapists is not feasible due to the nature of the behavioural group intervention. Outcome measures are self-reported questionnaires. Data analysis will be conducted using coded datasets to minimise bias.
Intervention model description
Participants with primary brain tumours receiving systemic anti-cancer treatment will be randomised in a 1:1 ratio to either a six-week occupational therapy-led group intervention (OT SMILE) or usual care consisting of written lifestyle management information. Randomisation will be computer-generated by an independent researcher not involved in recruitment or intervention delivery. Outcomes will be assessed at baseline and at 6 weeks. Cohort-based recruitment will allow delivery of small group sessions (6-8 participants per cohort) while maintaining random allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age ≥ 18 years Diagnosis of primary brain tumour Currently receiving systemic anti-cancer treatment (SACT) Experiencing difficulty with occupational performance (self-reported or clinician-identified) Sufficient cognitive and communication ability to participate in group sessions (assessed clinically and/or via screening tool) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Able to provide written informed consent
Exclusion criteria
ECOG performance status ≥ 3 Current inpatient status Major depressive episode or significant psychiatric condition preventing participation in group sessions Significant language barrier preventing participation in English-language sessions Inability to provide informed consent \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Functional Assessment of Cancer Therapy - Brain (FACT-BR) Total Score | Baseline and 6 weeks (end of intervention period) | Change from baseline to post-intervention in health-related quality of life as measured by the Functional Assessment of Cancer Therapy - Brain (FACT-BR) total score. The FACT-BR is a validated patient-reported outcome instrument assessing physical, social, emotional, and functional well-being in individuals with brain tumours. Higher scores indicate better quality of life. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Fatigue Inventory (BFI) Score | Baseline and 6 weeks | Change from baseline to post-intervention in patient-reported fatigue severity as measured by the Brief Fatigue Inventory (BFI). The BFI assesses fatigue severity and its impact on daily functioning. Higher scores indicate greater fatigue. |
| Change in Canadian Occupational Performance Measure (COPM) Performance and Satisfaction Scores | Baseline and 6 weeks | Change from baseline to post-intervention in self-rated occupational performance and satisfaction scores as measured by the Canadian Occupational Performance Measure (COPM). The COPM assesses perceived performance in meaningful daily activities and satisfaction with performance. |
Countries
Ireland
Contacts
CONTACTCaoilfhionn O Donovan
Outcome results
None listed