Primary Brain TumourOTSMILENCT07426848
OT SMILE: Occupational Therapy Group Intervention for Primary Brain Tumour Patients
A study testing Standard Lifestyle Management Literature and OT SMILE Occupational Therapy Group Programme in people with Primary Brain Tumour and Glioblastoma, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Brain Tumour, Glioblastoma, Brain Neoplasms
- What is being tested?
- Standard Lifestyle Management Literature and OT SMILE Occupational Therapy Group Programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteIreland
- Study dates
- 18 Dec 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland1 site, 1 recruiting
- Recruiting
Beaumont RCSI Cancer Centre
Dublin, Beaumont, D09V2N0
Aisling Hegarty, PhD, 018093000, Aislinghegarty@rcsi.ie
About this study
Official title: Occupational Therapy Symptom Management Through Innovative Lifestyle Engagement (OT SMILE): A Randomised Controlled Trial in Patients With Primary Brain Tumours
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.
Read more
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.
Read the detailed description
Background and Rationale
Primary brain tumour patients frequently experience substantial symptom burden, including fatigue, cognitive dysfunction, neurological deficits, emotional distress, and reduced participation in activities of daily living. These symptoms may arise from tumour-related pathology, surgical intervention, radiotherapy, chemotherapy, or systemic anti-cancer treatment (SACT). Functional decline significantly impacts independence and health-related quality of life.
Although rehabilitation interventions have demonstrated benefits in broader oncology populations, there is limited evidence specifically addressing structured occupational therapy (OT)-led group interventions for patients with primary brain tumours, particularly in an Irish healthcare setting.
Occupational therapy focuses on enabling participation in meaningful daily activities through structured goal setting, fatigue management strategies, activity modification, cognitive compensation techniques, and behavioural self-management approaches. Group-based interventions may provide additional benefits including peer support, shared problem-solving, and enhanced motivation.
The OT SMILE study is designed to evaluate the effectiveness of a structured OT-led group intervention in improving health-related quality of life and symptom management among outpatients with primary brain tumours undergoing active systemic treatment.
Study Design
This is a single-centre, prospective, open-label, parallel-group randomised controlled trial conducted at Beaumont Hospital.
Participants will be randomised in a 1:1 ratio to either:
OT SMILE intervention group
Usual care control group
Randomisation will be computer-generated by an independent researcher not involved in recruitment or intervention delivery. Due to the behavioural nature of the intervention, blinding of participants and therapists is not feasible.
Intervention
The OT SMILE programme consists of six weekly group sessions, each lasting approximately 90 minutes, delivered by registered occupational therapists. Groups will include approximately 6-8 participants per cohort.
Session components include:
Education regarding common symptoms in primary brain tumour patients
Fatigue management strategies
Goal setting and activity pacing
Relaxation techniques
Cognitive strategies to support daily functioning
Exercise and physical activity guidance
Nutrition education
Peer support and shared problem-solving
Strategies for habit formation and long-term self-management
Participants in the control group will receive standard written lifestyle management information and continue usual oncology care.
Outcome Assessment
Outcome measures will be collected at baseline and at completion of the six-week intervention period.
The primary outcome is change in health-related quality of life measured using the Functional Assessment of Cancer Therapy - Brain (FACT-BR).
Secondary outcomes include fatigue severity (Brief Fatigue Inventory) and health utility/quality of life (EQ-5D-5L). Occupational performance and satisfaction (Canadian Occupational Performance Measure) will also be assessed in the intervention group.
- Conditions
- Primary Brain Tumour, Glioblastoma, Brain Neoplasms
- Being tested
- Standard Lifestyle Management Literature, OT SMILE Occupational Therapy Group Programme
- Keywords
- Occupational Therapy, Symptom Management, Brain Cancer, Neuro-Oncology, Supportive Care, Rehabilitation, Health Related Quality of Life, FACT-BR
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Lifestyle Management LiteratureOther
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 ProgrammeBehavioural
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 group | Role | What they receive |
|---|---|---|
| Standard Lifestyle Management Literature (Control) | Active comparator | 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. Receives: Other: Standard Lifestyle Management Literature |
| OT SMILE Occupational Therapy Group Intervention | Experimental | 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). Receives: Behavioral: OT SMILE Occupational Therapy Group Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks (end of intervention period)
Secondary outcomes (2)
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.
Measured: Baseline and 6 weeks
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.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start18 Dec 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Brain TumourStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants with primary brain tumours receiving systemic anti-cancer treatment will be randomised in a 1:1 ratio to either a six-week occupational therapy-led group intervention (OT SMILE) or usual care consisting of written lifestyle management information. Randomisation will be computer-generated by an independent researcher not involved in recruitment or intervention delivery. Outcomes will be assessed at baseline and at 6 weeks. Cohort-based recruitment will allow delivery of small group sessions (6-8 participants per cohort) while maintaining random allocation.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426848
- Sponsor's protocol ID
- 25-73
- Acronym
- OTSMILE
- Status last verified
- Feb 2026
- First submitted
- 16 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy Symptom Management Through Innovative Lifestyle Engagement (OT SMILE): A Randomised Controlled Trial in Patients With Primary Brain Tumours
- ClinicalTrials.gov ID
- NCT07426848
- Acronym / sponsor ID
- OTSMILE / 25-73
- Conditions
- Primary Brain Tumour, Glioblastoma, Brain Neoplasms
- Keywords
- Occupational Therapy, Symptom Management, Brain Cancer, Neuro-Oncology, Supportive Care, Rehabilitation, Health Related Quality of Life, FACT-BR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale
Primary brain tumour patients frequently experience substantial symptom burden, including fatigue, cognitive dysfunction, neurological deficits, emotional distress, and reduced participation in activities of daily living. These symptoms may arise from tumour-related pathology, surgical intervention, radiotherapy, chemotherapy, or systemic anti-cancer treatment (SACT). Functional decline significantly impacts independence and health-related quality of life.
Although rehabilitation interventions have demonstrated benefits in broader oncology populations, there is limited evidence specifically addressing structured occupational therapy (OT)-led group interventions for patients with primary brain tumours, particularly in an Irish healthcare setting.
Occupational therapy focuses on enabling participation in meaningful daily activities through structured goal setting, fatigue management strategies, activity modification, cognitive compensation techniques, and behavioural self-management approaches. Group-based interventions may provide additional benefits including peer support, shared problem-solving, and enhanced motivation.
The OT SMILE study is designed to evaluate the effectiveness of a structured OT-led group intervention in improving health-related quality of life and symptom management among outpatients with primary brain tumours undergoing active systemic treatment.
Study Design
This is a single-centre, prospective, open-label, parallel-group randomised controlled trial conducted at Beaumont Hospital.
Participants will be randomised in a 1:1 ratio to either:
OT SMILE intervention group
Usual care control group
Randomisation will be computer-generated by an independent researcher not involved in recruitment or intervention delivery. Due to the behavioural nature of the intervention, blinding of participants and therapists is not feasible.
Intervention
The OT SMILE programme consists of six weekly group sessions, each lasting approximately 90 minutes, delivered by registered occupational therapists. Groups will include approximately 6-8 participants per cohort.
Session components include:
Education regarding common symptoms in primary brain tumour patients
Fatigue management strategies
Goal setting and activity pacing
Relaxation techniques
Cognitive strategies to support daily functioning
Exercise and physical activity guidance
Nutrition education
Peer support and shared problem-solving
Strategies for habit formation and long-term self-management
Participants in the control group will receive standard written lifestyle management information and continue usual oncology care.
Outcome Assessment
Outcome measures will be collected at baseline and at completion of the six-week intervention period.
The primary outcome is change in health-related quality of life measured using the Functional Assessment of Cancer Therapy - Brain (FACT-BR).
Secondary outcomes include fatigue severity (Brief Fatigue Inventory) and health utility/quality of life (EQ-5D-5L). Occupational performance and satisfaction (Canadian Occupational Performance Measure) will also be assessed in the intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with primary brain tumours receiving systemic anti-cancer treatment will be randomised in a 1:1 ratio to either a six-week occupational therapy-led group intervention (OT SMILE) or usual care consisting of written lifestyle management information. Randomisation will be computer-generated by an independent researcher not involved in recruitment or intervention delivery. Outcomes will be assessed at baseline and at 6 weeks. Cohort-based recruitment will allow delivery of small group sessions (6-8 participants per cohort) while maintaining random allocation.
| Arm | Type | Receives |
|---|---|---|
| Standard Lifestyle Management Literature (Control) | Active comparator | Other: Standard Lifestyle Management LiteratureParticipants receive standard written lifestyle management information regarding symptom management and self-care strategies and continue usual oncology care. No structured group intervention is provided. |
| OT SMILE Occupational Therapy Group Intervention | Experimental | Behavioral: OT SMILE Occupational Therapy Group ProgrammeParticipants 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Lifestyle Management LiteratureProvision of written educational materials addressing symptom management, fatigue, activity pacing, and lifestyle strategies. Participants continue routine oncology care without structured occupational therapy group sessions. | Other | Standard Lifestyle Management Literature (Control) |
| OT SMILE Occupational Therapy Group ProgrammeA 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. | Behavioural | OT SMILE Occupational Therapy Group Intervention |
Primary outcome
Change in Functional Assessment of Cancer Therapy - Brain (FACT-BR) Total Score
Time frame: 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.
2 secondary outcomes
Change in Brief Fatigue Inventory (BFI) Score
Time frame: Baseline and 6 weeks
Change in Canadian Occupational Performance Measure (COPM) Performance and Satisfaction Scores
Time frame: Baseline and 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Lifestyle Management Literature and OT SMILE Occupational Therapy Group Programme in people with Primary Brain Tumour and Glioblastoma, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caoilfhionn O Donovan (+35318093000, caoilfhionnodonovan@rcsi.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Assessment of Cancer Therapy - Brain (FACT-BR) Total Score (time frame: Baseline and 6 weeks (end of intervention period)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.