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

Official title

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

Overview

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Change in Functional Assessment of Cancer Therapy - Brain (FACT-BR) Total Score [Time frame: Baseline and 6 weeks (end of intervention period)]

Secondary outcome measures (2)

• 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]

Eligibility criteria

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

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

Ireland · 1 center

• Beaumont RCSI Cancer Centre — Dublin

Identifiers

NCT: NCT07426848 · 25-73

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗