OT SMILE: Occupational Therapy Group Intervention for Primary Brain Tumour Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal College of Surgeons, Ireland
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Lifestyle Management Literature
Other interventionProvision 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
BehavioralA 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.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Standard Lifestyle Management Literature (Control)Active comparator 1 intervention
Group B: OT SMILE Occupational Therapy Group InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Functional Assessment of Cancer Therapy - Brain (FACT-BR) Total Score
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.
Time frame
Baseline and 6 weeks (end of intervention period)Secondary outcomes
1
Change in Brief Fatigue Inventory (BFI) Score
Change from baseline to post-intervention in patient-reported fatigue severity as measured by the Brief Fatigue Inventory (BFI). The BFI assesses fatigue severity and its impact on daily functioning. Higher scores indicate greater fatigue.
Time frame
Baseline and 6 weeks2
Change in Canadian Occupational Performance Measure (COPM) Performance and Satisfaction Scores
Change from baseline to post-intervention in self-rated occupational performance and satisfaction scores as measured by the Canadian Occupational Performance Measure (COPM). The COPM assesses perceived performance in meaningful daily activities and satisfaction with performance.
Time frame
Baseline and 6 weeksSponsors and contacts
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Source ClinicalTrials.gov