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

NCT07426848 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-02-23

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Royal College of Surgeons, Ireland

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-18
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07426848 on ClinicalTrials.gov