Actively Recruiting
Occupational Therapy Symptom Management Through Innovative Lifestyle Engagement (OT SMILE): A Randomised Controlled Trial in Patients With Primary Brain Tumours
Led by Royal College of Surgeons, Ireland · Updated on 2026-02-23
96
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
People diagnosed with primary brain tumours often face symptoms such as fatigue, cognitive changes, anxiety, and reduced ability to perform daily activities. These symptoms can result from the tumour or ongoing systemic anti-cancer treatments. Access to structured rehabilitation and symptom management programs is limited in Ireland. This trial evaluates whether a structured occupational therapy-led group program can improve quality of life and daily functioning in adults with primary brain tumours receiving active treatment. Participants will be randomly assigned to one of two groups: a six-week occupational therapy group program called OT SMILE or usual care which includes written lifestyle management information. The OT SMILE program consists of six weekly 90-minute group sessions led by occupational therapists, focusing on fatigue management, activity modification, cognitive strategies, relaxation techniques, goal setting, exercise, nutrition, and peer support. Participants in both groups will complete questionnaires before and after the six-week period to measure quality of life, fatigue, and daily functioning. The main goal is to determine if the occupational therapy program improves health-related quality of life compared to usual care. Assessments include the Functional Assessment of Cancer Therapy - Brain (FACT-BR), Brief Fatigue Inventory, and Canadian Occupational Performance Measure. The study is conducted at Beaumont Hospital and sponsored by the Royal College of Surgeons, Ireland.
CONDITIONS
Brief Title
OT SMILE: Occupational Therapy Group Intervention for Primary Brain Tumour Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of primary brain tumour
- Currently receiving systemic anti-cancer treatment
- Experiencing difficulty with occupational performance (self-reported or clinician-identified)
- Sufficient cognitive and communication ability to participate in group sessions
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Able to provide written informed consent
You will not qualify if you...
- Eastern Cooperative Oncology Group (ECOG) performance status of 3 or higher
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants in the intervention group attend six weekly 90-minute occupational therapy group sessions focusing on symptom management, fatigue strategies, cognitive support, and peer support. Participants in the control group receive standard written lifestyle management information and continue usual oncology care without group sessions.
Weekly visits for 6 weeks
Duration - At completion of 6-week intervention
Outcome assessments are performed to evaluate changes in quality of life, fatigue, and occupational performance at the end of the intervention period.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Beaumont RCSI Cancer Centre
Dublin, Beaumont, Ireland, D09V2N0
Actively Recruiting
Research Team
C
Caoilfhionn O Donovan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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