Continuous Quality Improvement (CQI) Pilot Study Evaluating the Utility of an Educational Video
This trial is active, not recruiting.
|Treatments||video group, verbal group|
|Sponsor||University of California, Davis|
|Start date||November 2012|
|End date||March 2014|
|Trial size||44 participants|
|Trial identifier||NCT02062853, 384968|
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.
|Intervention model||parallel assignment|
|Primary purpose||health services research|
Level of Patient Satisfaction in Relation to Treatment Effects and Expectations of 5-fluorouracil Cream
time frame: 4 weeks
Male or female participants at least 18 years old.
Inclusion Criteria: - 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). Exclusion Criteria: - 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).
|Official title||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|
|Principal investigator||Nasim Fazel, M.D., D.D.S.|
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