A Prospective Randomised Controlled Clinical Trial Investigating the Benefits of Patient-customised Headrests Versus Standard (Non-patient Specific) Headrests in the Immobilisation of Patients Receiving Radiotherapy for Head and Neck Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Treatment set-up accuracy
研究概览
简要总结
RATIONALE: Using a customized headrest to hold patients in one position may help doctors plan treatment for patients with head and neck cancer. It is not yet known whether a customized headrest is more effective than a standard headrest in holding patients still during radiation therapy.
PURPOSE: This randomized clinical trial is studying a customized headrest to see how well it works compared with a standard headrest in holding patients still while undergoing radiation therapy for head and neck cancer.
详细描述
OBJECTIVES:
Primary
- To evaluate and compare the treatment set-up accuracy of customized vs standard headrest in immobilizing patients undergoing radiotherapy for head and neck cancer.
- To determine and compare patient comfort with the two immobilization techniques.
Secondary
- To evaluate radiation therapists' satisfaction with the two immobilization techniques.
- To examine and compare the cost effectiveness of the two immobilization techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed head and neck malignancy
- •Planning to undergo radical 3-dimensional conformal radiotherapy (using the Oncentra MasterPlan treatment planning system) at St Luke's Hospital
- •PATIENT CHARACTERISTICS:
- •No evidence of any other significant clinical disorder or laboratory finding that would make it undesirable for the patient to participate in the study
- •Able to comply with the study, in the opinion of the researcher and/or medical team
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
排除标准
- 未提供
研究组 & 干预措施
Control
Immobilisation: Standard headrest plus individual customised mask (orfit)
干预措施: questionnaire administration (Other)
Control
Immobilisation: Standard headrest plus individual customised mask (orfit)
干预措施: 3-dimensional conformal radiation therapy (Radiation)
Control
Immobilisation: Standard headrest plus individual customised mask (orfit)
干预措施: radiation therapy treatment planning/simulation (Radiation)
TRial Arm
Immobilisation: Customised headrest plus individual customised mask (orfit)
干预措施: 3-dimensional conformal radiation therapy (Radiation)
TRial Arm
Immobilisation: Customised headrest plus individual customised mask (orfit)
干预措施: radiation therapy treatment planning/simulation (Radiation)
TRial Arm
Immobilisation: Customised headrest plus individual customised mask (orfit)
干预措施: questionnaire administration (Other)
结局指标
主要结局
Treatment set-up accuracy
时间窗: 2010
Patient comfort with the two immobilization techniques as assessed by a patient-scored Visual Analogue Scale
时间窗: 2010
次要结局
- Cost-effectiveness as assessed by resource implications of the two immobilization techniques(2010)
- Radiation therapists' satisfaction as assessed by a questionnaire(2010)