CQI Pilot Study Evaluating the Utility of an Educational Video in the Setting of Topical 5-fluorouracil Therapy to Treat Actinic Keratoses and Its Influence on Patient Satisfaction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Level of Patient Satisfaction in Relation to Treatment Effects and Expectations of 5-fluorouracil Cream
研究概览
简要总结
The primary aim of this study is to evaluate the effects of prospective patient education on patient satisfaction with administration of topical 5% 5-fluorouracil cream for the treatment of actinic keratosis involving the face, scalp, upper chest, dorsal hands and forearms. Specifically, this study aims to determine if prospective patient viewing of an educational video delineating treatment effects and expectations improves patient satisfaction and treatment completion rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Subjects with a clinical diagnosis of actinic keratoses with at least 6 clinically-diagnosed actinic keratoses on the face, bald scalp, arms, upper chest, OR dorsal hands classified as grade I, mild (slightly palpable actinic keratoses, more easily felt than seen), and II, moderate (moderately thick hyperkeratotic actinic keratoses, easily felt).
排除标准
- •Patients using interferon or interferon inducers, immunomodulators, cytotoxic or immunosuppressor drugs, corticosteroids, retinoids, or investigational drugs within 4 weeks prior to enrollment.
- •Patients who have been treated with any topical drug for actinic keratoses lesions less than 8 weeks prior to enrollment.
- •Patients with invasive tumors within the treated area (e.g. invasive squamous cell carcinoma)
- •Patients who have exhibited any dermatological disease within the treated or adjacent (3 cm distance) area at the time of screening.
- •Patients who have known allergies to fluorouracil (5-FU).
研究组 & 干预措施
Video Group
Subjects view educational video on the use of cream medication for the treatment of actinic keratoses.
干预措施: Video Group (Other)
Verbal Group
Subjects are given verbal instructions on the use of cream medication for the treatment of actinic keratoses.
干预措施: Verbal Group (Other)
结局指标
主要结局
Level of Patient Satisfaction in Relation to Treatment Effects and Expectations of 5-fluorouracil Cream
时间窗: 4 weeks
The level of patient satisfaction will be assessed via questionnaire and visual analog scale.
次要结局
未报告次要终点