Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07426848

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

Led by Royal College of Surgeons, Ireland · Updated on 2026-02-23

96

Participants Needed

1

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 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 64 2
  • Able to provide written informed consent
Not Eligible

You will not qualify if you...

  • ECOG performance status e= 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Beaumont RCSI Cancer Centre

Dublin, Beaumont, Ireland, D09V2N0

Actively Recruiting

Loading map...

Research Team

C

Caoilfhionn O Donovan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here