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

Recruiting now · Not applicable

Conditions studied: Primary Brain Tumour, Glioblastoma, Brain Neoplasms

In brief

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.

Key facts

Study ID

NCT07426848

Run by

Royal College of Surgeons, Ireland

People needed

96

Starts

2025-12-18

Expected to finish

2028-12-31

Last updated by the study team

2026-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

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

Full record on ClinicalTrials.gov

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