Occupational Therapy Group Programme for Adults With Primary Brain Tumours
Tests an occupational therapy group programme in adults with primary brain tumours.
Key facts
- Who runs it
- Royal College of Surgeons, Ireland
- Where
- Dublin, IrelandSee the site
- Trial code
- Registry title
- OT SMILE: Occupational Therapy Group Intervention for Primary Brain Tumour Patients
- Status
- Recruiting
- People taking part
- 96 people, planned
- Started
- 18 Dec 2025
- Expected to end
- 31 Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Standard Lifestyle Management Literature
- OT SMILE Occupational Therapy Group Programme
- Record updated
- 23 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a primary brain tumour who are on cancer drug treatment and have trouble with everyday activities. It tests a six-week group programme led by occupational therapists.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Primary brain tumour; ECOG performance status of 2 or lower.
- Earlier treatment
- Must be currently receiving systemic anti-cancer treatment (SACT).
Main reasons for not taking part
- ECOG performance status of 3 or higher
- Currently an inpatient
- Major depressive episode or significant psychiatric condition that stops group participation
- Language barrier that stops participation in English-language sessions
- Cannot give informed consent
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- -
Where in Ireland
- Beaumont RCSI Cancer CentreDublin, IrelandContact: Aisling Hegarty, PhDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Standard Lifestyle Management Literature (Control)Existing treatment, for comparison
Participants receive standard written lifestyle management information regarding symptom management and self-care strategies and continue usual oncology care. No structured group intervention is provided.
Treatment: Standard Lifestyle Management Literature
- OT SMILE Occupational Therapy Group InterventionTreatment being tested
Participants receive a structured six-week occupational therapy-led group intervention in addition to usual oncology care. The programme consists of six weekly 90-minute sessions delivered in small groups (6-8 participants per cohort).
Treatment: OT SMILE Occupational Therapy Group Programme
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Occupational Therapy Symptom Management Through Innovative Lifestyle Engagement (OT SMILE): A Randomised Controlled Trial in Patients With Primary Brain Tumours
- Plain-language title
- Occupational Therapy Group Programme for Adults With Primary Brain TumoursGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 13 November 2026.
- Record updated
- 23 February 2026