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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Ireland
Beaumont RCSI Cancer Centre
RECRUITING
Dublin
Contact Information
Primary
Caoilfhionn O Donovan
caoilfhionnodonovan@rcsi.ie
+35318093000
Time Frame
Start Date: 2025-12-18
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 96
Treatments
Active_comparator: Standard Lifestyle Management Literature (Control)
Participants receive standard written lifestyle management information regarding symptom management and self-care strategies and continue usual oncology care. No structured group intervention is provided.
Experimental: OT SMILE Occupational Therapy Group Intervention
Participants receive a structured six-week occupational therapy-led group intervention in addition to usual oncology care. The programme consists of six weekly 90-minute sessions delivered in small groups (6-8 participants per cohort).
Sponsors
Leads: Royal College of Surgeons, Ireland

This content was sourced from clinicaltrials.gov