跳至主要内容
临床试验/NCT01015326
NCT01015326已完成不适用

Development of a Functional Assessment of Side-effects to Therapy (FAST) Questionnaire to Assess Dermatology-Related Quality of Life in Patients Treated With EGFR Inhibitors: The FAST-EGFR Inhibitors: The FAST-EGFRI and Development of an Investigator Grading System: The Skin and Eye Reactions to Inhibitors of EGFR (SERIES) Score

Northwestern University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2006年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL)

研究概览

简要总结

Epidermal Growth Factor Receptor Inhibitors (EGFRI) are associated with skin toxicities. Clinical experience suggests that skin toxicities interfere with health related quality of life (HRQL) and may interfere with treatment adherence. No systematic investigations of EGFRI-associated dermatologic toxicities and impact on HRQL have been reported. No patient-reported outcome measures exist to capture the unique concerns of oncology patients who experience EGFRI-associated dermatologic toxicities.

The purpose of this study is to develop a patient-reported outcomes measure to assess dermatologic-related symptoms burden and health-related quality of life among patients receiving an EGFRI, and to develop a grading system for EGFRI-associated dermatologic toxicities.

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

入选标准

  • Undergoing anti-EGFR cancer therapy
  • Over 18 years old

排除标准

  • Unable to complete the questionnaire
  • Unable to follow instructions or give consent

结局指标

主要结局

Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL)

时间窗: at time of questionnaire

Patients were asked "How important is this symptoms or concern to your quality of life?" They were given a series of items (listed in the table) and instructed to assign each item a numerical value of 0 to 3, where 0 is equivalent to "not at all important" and 3 is equivalent to "extremely important." Experts were asked "How important is this symptom or concern to patients' quality of life?" They were given the same series of items and instructed to assign each item a numerical value of 0 to 3, where 0 is equivalent to "not at all important" and 3 is equivalent to "extremely important." For each item, a mean score was calculated using the values assigned to that item from all patients, and a second mean score was calculated using the values assigned to that item from all experts. An item's mean score may range from 0 to 3, where 0 is equivalent to "not at all important to quality of life" and where 3 is equivalent to "extremely important to quality of life."

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dennis West

Professor in Dermatology and Pediatrics

Northwestern University

研究点 (1)

Loading locations...

相似试验