Group occupational therapy program to help adults with primary brain tumours manage daily activities

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

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

• Phase: NA
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Royal College of Surgeons, Ireland (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Dublin, Beaumont)
• Trial ID: NCT07426848 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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

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Where this trial is running

Dublin, Beaumont

• Beaumont RCSI Cancer Centre — Dublin, Beaumont, Ireland (RECRUITING)

Study contacts

• Study coordinator: Caoilfhionn O Donovan

Conditions: Primary Brain Tumour, Glioblastoma, Brain Neoplasms, Occupational Therapy, Symptom Management, Brain Cancer, Neuro-Oncology, Supportive Care