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

February 16, 2026 updated by: Royal College of Surgeons, Ireland

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ireland
    • Beaumont
      • Dublin, Beaumont, Ireland, D09V2N0
        • Recruiting
        • Beaumont RCSI Cancer Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Other: 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.
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).
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 6 weeks (end of intervention period)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Brief Fatigue Inventory (BFI) Score
Time Frame: Baseline and 6 weeks
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.
Baseline and 6 weeks
Change in Canadian Occupational Performance Measure (COPM) Performance and Satisfaction Scores
Time Frame: Baseline and 6 weeks
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.
Baseline and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

February 16, 2026

First Posted (Actual)

February 23, 2026

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 16, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-73

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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