RecruitingNot ApplicableNCT07426848

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

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


Sponsor

Royal College of Surgeons, Ireland

Enrollment

96 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study (OT SMILE) is testing an occupational therapy group program for people with primary brain tumours who are currently receiving cancer treatment and finding it hard to carry out daily activities. The program aims to help participants manage daily tasks, maintain independence, and improve quality of life. **You may be eligible if...** - You are 18 years old or older - You have a primary brain tumour - You are currently receiving systemic cancer treatment (such as chemotherapy) - You are having difficulties with everyday activities (e.g., self-care, work, or leisure) - You have enough thinking and communication ability to participate in group sessions - You are well enough to participate (ECOG performance status of 2 or below) **You may NOT be eligible if...** - You are too unwell to take part (ECOG score of 3 or higher) - You are currently admitted to hospital - You have a significant psychiatric condition preventing group participation - You have a significant language barrier to participating in English-language sessions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard Lifestyle Management Literature

Provision of written educational materials addressing symptom management, fatigue, activity pacing, and lifestyle strategies. Participants continue routine oncology care without structured occupational therapy group sessions.

BEHAVIORALOT SMILE Occupational Therapy Group Programme

A structured six-week group-based occupational therapy programme delivered by registered occupational therapists. Sessions include fatigue management strategies, goal setting, activity pacing, cognitive strategies, relaxation techniques, exercise guidance, nutrition education, peer support, and strategies to support long-term self-management. Each session lasts approximately 90 minutes and is delivered weekly.


Locations(1)

Beaumont RCSI Cancer Centre

Dublin, Beaumont, Ireland

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NCT07426848


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