NCT07426848

OT SMILE: Occupational Therapy Group Intervention for Primary Brain Tumour Patients

Occupational Therapy Symptom Management Through Innovative Lifestyle Engagement (OT SMILE): A Randomised Controlled Trial in Patients With Primary Brain Tumours

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Royal College of Surgeons, Ireland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Brain Tumour
• Glioblastoma
• Brain Neoplasms

Interventions

Type	Name	Description
OTHER	Standard 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.
BEHAVIORAL	OT 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.

Timeline

• Start date: 2025-12-18
• Primary completion: 2027-12-31
• Completion: 2028-12-31
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Ireland