Research Study: Tattooing of Skin Landmarks in Radiotherapy: Comparison Between the System Traditional and Comfort Marker 2.0® (COMFORTATTOO)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patients' comfort
研究概览
简要总结
Comparison on radiotherapy skin set-up markings with lancets versus Comfort Marker 2.0®
详细描述
A Prospective, unicentric, randomized, controlled, parallel, double-blinded, cohort study comparing radiotherapy skin set-up markings with lancets versus electric marking device (Comfort Marker 2.0® by CIVCO®)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
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 at least 18 years old.
- •Patients referred to our department to receive external beam radiation therapy.
- •Eastern Cooperative Oncology Group performance status of 0 to
- •Estimated fractionating schedule of at least 13 once-daily fractions.
- •Written informed consent.
排除标准
- •Patients requiring either immobilisation thermoplastic masks (for head or head and shoulders) or vacuum cushion.
结局指标
主要结局
Patients' comfort
时间窗: Day 1
Comfort is verbally assessed on the 11-point numeric pain scale. As more than one reference point is tattooed, the patients are asked to give an overall score to the procedure.
Effectiveness
时间窗: up to 7 weeks
Effectiveness is assessed by the RTT team that delivered the daily fractions. Skin markings are individually evaluated at several periods, specifically at the first fraction, then every 5 fractions, and one last time in the last fraction of RT. These evaluations are scored on a 4-point graded scale (corresponding to bad, reasonable, good, and excellent).
次要结局
- RTTs' satisfaction(Day 1)
- Cosmesis(one of the last three days of irradiation)
研究者
André Miranda Pires
Principal Investigator
Instituto Portugues de Oncologia, Francisco Gentil, Porto