A Randomised Controlled Trial Comparing the Accuracy and Acceptability of Closed-face and Open-face Thermoplastic Immobilisation Shells in Cranial Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells
研究概览
简要总结
Patients having radiotherapy to their head and neck wear an immobilisation shell to prevent patient movement and improve treatment accuracy. These shells tend to cover the face and have the potential to cause anxiety and distress in patients, particularly if they suffer with claustrophobia or a similar fear. The study will use an 'open-face' shell that does not cover the face and compare this with the investigators' current 'closed-face' shell. The investigators will obtain treatment verification x-ray images to assess the daily set-up errors and compare these between the two shell type, and ask both patients and radiographers of their experiences from using the shells.
Hypothesis: Open-face immobilisation shells offer equivalent accuracy and efficiency of radiotherapy delivery and are better accepted by patients and radiographers as compared to closed-face immobilisation shells for cranial radiotherapy.
详细描述
Patients will be randomised into one of two groups, with group A acting as the control group using the investigators' standard 3--point closed--face shell, and group B using the 3--point open--face shell (experimental group). Each procedure is discussed with the patient before commencement. Patients will be positioned into the optimal treatment position and the shell will be fabricated as per manufacturer instructions by pre-treatment radiographers. This is followed by the patient having a planning CT scan of their head while wearing their shell to allows radiographers and doctors to localise and plan the treatment. At the end of this appointment, the patient will be asked to complete the first of three questionnaires regarding their experience of wearing the shell. Radiographers will be asked to complete a questionnaire of their experience of using the shell, and complete timing data for the procedures.
On the first day of treatment, radiographers will discuss the treatment process and side effects of treatment with the patient, and treatment will be delivered under current department protocols using linear accelerators (linacs). During the course of the treatment, radiographers will obtain 5 sets of verification images for the study, and these will be assessed for set-up errors as per current department policy. Where possible, treatment fields will be used to verify patient position to keep radiation doses from verification imaging as low as reasonably practicable (ALARP). Patients will be asked to complete two more questionnaires on their experience, one on their first day and one on their last day of treatment. Radiographers will also complete questionnaires on these days. Timing data will be obtained for all treatment fractions.
The patient's perspective of the planning and treatment processes will be almost identical to that of patients having cranial radiotherapy that are not in the trial. The only differences that will be observed will be the use of an open-face shell (for patients in group B), completion of three questionnaires, and additional verification imaging.
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
- •patients prescribed cranial radiotherapy using virtually simulated parallel opposed fields with:
- •5 or more fractions of virtually simulated cranial radiotherapy
- •treatment for Primary Central Nervous System Lymphoma (PCNSL), prophylactic cranial irradiation (PCI), or primary or secondary cerebral or bony lesions
排除标准
- •patients unable to give informed consent
- •patients requiring conformal or inverse-planned radiotherapy
- •patients requiring stereotactic radiotherapy
- •patients who have previously had cranial or head and neck radiotherapy
研究组 & 干预措施
Group A: Closed-face shells
Cranial radiotherapy using the control closed-face immobilisation shell.
干预措施: Group A: Closed-face shell (Device)
Group B: open-face shell
Cranial radiotherapy using the experimental open-face immobilisation shell
干预措施: Group B: Open-face shell (Device)
结局指标
主要结局
Assessment of treatment verification imaging to determine inter-fraction reproducability of immobilisation shells
时间窗: within 2 weeks of completion of treatment
Assessment of verification imaging to determine individual systematic and random errors. Individual errors are collated to determine group systematic and random errors for comparison.
次要结局
- Assessment of imaging to determine intra-fraction motion(within 2 weeks of patient completion of treatment)
- Patient acceptance and tolerability of immobilisation shells (last fraction)(within 2 weeks of patient completion of treatment)
- Patient acceptance and tolerability of immobilisation shells (pre-treatment)(within 2 weeks of patient completion of treatment)
- Radiographer satisfaction of using immobilisation shells (treatment)(within 2 weeks of patient completion of treatment)
- Timing data(within 2 weeks of patient completion of treatment)
- Patient acceptance and tolerability of immobilisation shells (1st fraction)(within 2 weeks of patient completion of treatment)
- Radiographer satisfaction of using immobilisation shells (pre-treatment)(within 2 weeks of patient completion of treatment)