Patient-reported Experience and Symptom Measures on Prophylactic Use of Mepitel Film During Post-operative Breast Irradiation - a Danish Intra-patient Randomized Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 主要终点
- Patient-reported outcome measures (PRO)
研究概览
简要总结
Breast cancer patients in post-operative radiotherapy (RT) often experience acute skin reactions like erythema, pain, itching and oversensitivity. In 2014 a New Zealand randomized controlled trial (RCT) investigated the prophylactic use of safetac-based film, Mepitel Film, on half of the breast during RT compared to cream, resulting in significant differences in skin moist desquamation (0% vs. 26%). Despite changes in treatment modalities in Denmark toward lower total RT doses, the level of RT-induced skin toxicity could still be of great importance for the patients. The aim of this study is patient-reported symptoms and patient-reported experiences with the prophylactic use of Mepitel Film compared to standard cream treatment.
详细描述
Aim:
The use of Mepitel Film in the RCT from New Zealand resulted in significant differences in the acute morbidity of the skin. However, the clinical experience in Denmark with the new RT treatment modalities for breast cancer patients with lower total doses and less treatment fractions indicate less severe skin toxicity than the old treatment modalities.
The primary endpoint of this study is to investigate if prophylactic use of Mepitel Film to prevent severe skin reactions makes a difference for the patient experience of their RT induced skin reactions compared to treating the symptoms when they appear according to present clinical guidelines. Additional to the patient-reported experiences with the prophylactic use of Mepitel Film, the patients are asked to report their acute symptoms from the skin in the area with or without Mepitel Film at the end of treatment and two weeks after treatment. A secondary endpoint was a blinded radiotherapy staff evaluation of dermatitis.
Method:
The study was a multicenter trial with participation of three Danish hospitals: Aarhus University Hospital (Herning site), Vejle Hospital, and Odense University Hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 125 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women referred to postoperative adjuvant radiotherapy for breast cancer from October 1st 2015 to February 29th 2016 at the three radiotherapy departments.
- •Who read and understand Danish
- •Patients must have signed and dated a written informed consent form in accordance with regulatory and institutional guidelines.
- •Patients must be willing and able to comply the questionnaires and attend a two-week follow-up posttreatment.
排除标准
- •Patients included in the ongoing Danish HYPO PBI protocol (hypofractionated partial breast irradiation)
结局指标
主要结局
Patient-reported outcome measures (PRO)
时间窗: Two-week follow-up after RT
The proportion of radiation-induced symptoms with or without film (pain, itching, burning sensation, edema, sensitive or flaky skin) and the effect on work/daily activities measured with a 4-Point Likert Scale (not at all, a little, some, a lot).
Patient-reported experience measures (PREM)
时间窗: Two-week follow-up after RT
Patient experiences and preferences regarding Mepitel film for women with breast cancer undergoing radiotherapy based on their own experience with skin toxicity. The PREM-questionnaire consisted of seven questions regarding comfort and preferences with a 4-point Likert scale (strongly agree, mildly agree, mildly disagree, strongly disagree).
次要结局
- Radiodermatitis(Two-week follow-up)
研究者
Pia Krause Møller
Clinical Nurse Specialist, MPH
Odense University Hospital