Occupational Therapy Symptom Management Through Innovative Lifestyle Engagement (OT SMILE): A Randomised Controlled Trial in Patients With Primary Brain Tumours
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in Functional Assessment of Cancer Therapy - Brain (FACT-BR) Total Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Standard Lifestyle Management Literature (Other)
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).
干预措施: OT SMILE Occupational Therapy Group Programme (Behavioral)
结局指标
主要结局
Change in Functional Assessment of Cancer Therapy - Brain (FACT-BR) Total Score
时间窗: 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.
次要结局
- 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)