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

NCT07426848 | Recruiting DMC

• 1 other identifier: 25-73
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

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.

  Baseline and 6 weeks (end of intervention period)

Secondary Outcomes (2)

• Change in Brief Fatigue Inventory (BFI) Score

  Baseline and 6 weeks

• Change in Canadian Occupational Performance Measure (COPM) Performance and Satisfaction Scores

  Baseline and 6 weeks

Study Arms (2)

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.

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).

Behavioral: OT SMILE Occupational Therapy Group Programme

Interventions

Standard Lifestyle Management Literature OTHER

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.

Standard Lifestyle Management Literature (Control)

OT SMILE Occupational Therapy Group Programme BEHAVIORAL

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.

OT SMILE Occupational Therapy Group Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal College of Surgeons, Ireland: lead

Study Sites (1)

Beaumont RCSI Cancer Centre

Dublin, Beaumont, D09V2N0, Ireland

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Caoilfhionn O Donovan

CONTACT

+35318093000; caoilfhionnodonovan@rcsi.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of participants and therapists is not feasible due to the nature of the behavioural group intervention. Outcome measures are self-reported questionnaires. Data analysis will be conducted using coded datasets to minimise bias.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: December 18, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IE (1)