Group occupational therapy program to help adults with primary brain tumours manage daily activities
Official title: Occupational Therapy Symptom Management Through Innovative Lifestyle Engagement (OT SMILE): A Randomised Controlled Trial in Patients With Primary Brain Tumours
Run by Royal College of Surgeons, Ireland · NCT07426848 · Data updated 2026-11-12
This program will try a six-week occupational therapy group to see if it helps adults with primary brain tumours on active treatment improve daily functioning and quality of life.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Dublin, Beaumont) |
| Status | Recruiting |
| Started | December 18, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | February 23, 2026 |
| Trial ID | NCT07426848 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with a confirmed primary brain tumour who are receiving systemic anti-cancer treatment, report difficulty with occupational performance, have ECOG ≤2, and can participate in English-language group sessions are ideal candidates.
✕Probably not a fit
Patients who are inpatient, have ECOG ≥3, have a major psychiatric condition, or lack sufficient cognitive or English-language ability to participate in group sessions are unlikely to benefit from this group intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, randomized, open-label trial at Beaumont RCSI Cancer Centre compares a six-week OT SMILE occupational therapy group program to usual care (written lifestyle management information) for outpatients with primary brain tumours receiving systemic anti-cancer treatment. Eligible participants are adults with primary brain tumours who report difficulty with everyday activities, have ECOG performance status ≤2, and can participate in English-language group sessions. The intervention consists of six weekly 90-minute group sessions led by occupational therapists focusing on goal setting, fatigue management, activity modification, cognitive compensation, and behavioral self-management. Outcomes focus on health-related quality of life, symptom management, and functional participation in daily activities.
Why it matters
Potential benefit: If successful, this program could help patients better manage fatigue, cognitive changes, and daily tasks, improving independence and quality of life.
How similar studies have gone: Rehabilitation and occupational therapy approaches have shown benefits in broader oncology populations, but structured OT-led group programs specifically for primary brain tumour patients are limited and largely untested in Ireland.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 \-
Where it's running
-
Beaumont RCSI Cancer Centre
Dublin, Beaumont, Ireland Recruiting
Study contacts
- Study coordinator: Caoilfhionn O Donovan
- Email: caoilfhionnodonovan@rcsi.ie
- Phone: +35318093000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.