NCT04485442进行中（未招募）不适用
Patient Reported Outcome Measures After Treatment of Skin Cancers on the Face - a Pilot Study
University Hospital, Basel, Switzerland1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年11月9日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Belastungs-Thermometer questionnaire
研究概览
简要总结
This study is to evaluate the psychological well-being in patients diagnosed with skin cancer (melanoma and Squamous Cell Carcinoma (SCC) in the face) at the time of diagnosis and after treatment. Patients diagnosed with primary melanoma and/or SCC and/or infiltrative basal cell carcinoma on the face subjected to surgical treatment (excision or Mohs Surgery) will be included. All patients will receive questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •individuals diagnosed with melanoma, SCC and/or infiltrative basal cell carcinoma on the face for surgical treatment and planned for excision or Mohs surgery
- •patients who are able to give informed consent
排除标准
- •Electrodesication and curettage of the tumour
结局指标
主要结局
Change in Belastungs-Thermometer questionnaire
时间窗: at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery)
extent of distress on a scale from 0-10 (0=no distress, 10=extremely distress).
次要结局
- Change in photos of the patients' tumors(at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery))
- Change in FACE-Q questionnaire(at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery))
- Change in European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30) questionnaire(at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery))
- Change in WHO-DAS questionnaire(at Screening Visit (V1), V3 (7 days post surgery), V4 (90 days post surgery), V5 (180 days post surgery), V6 (360 days post surgery))
研究者
研究点 (1)
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