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

Condition(s) studied

Investigational drug(s) / intervention(s)

Standard 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.

OT 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.

Study 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

Primary outcome measure(s)

• Change in Functional Assessment of Cancer Therapy - Brain (FACT-BR) Total Score — Baseline and 6 weeks (end of intervention period)
  Change from baseline to post-intervention in health-related quality of life as measured by the Functional Assessment of Cancer Therapy - Brain (FACT-BR) total score. The FACT-BR is a validated patient-reported outcome instrument assessing physical, social, emotional, and functional well-being in individuals with brain tumours. Higher scores indicate better quality of life.

Trial sites (1)

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