Development and Validation of a Quality of Life Instrument for Actinic Keratosis
- Conditions
- Actinic Keratosis
- Interventions
- Other: AKRQ questionnaireOther: Skindex-16, DLQI, Skin Health Calculator
- Registration Number
- NCT01444989
- Lead Sponsor
- Wake Forest University
- Brief Summary
Actinic keratoses (AKs) are some of the most common lesions seen by dermatologists. Flesh colored to erythematous, these lesions often present with scaling or crusting in sun damaged regions of the body. While they are physically visible and often palpable, these changes can also result in psychosocial changes in patients, including embarrassment about their skin or reduction in leisure activities to avoid further sun exposure. At the same time, AKs are known to progress in a significant number of cases to squamous cell carcinoma (SCC), a concern in terms of its metastatic potential.
The primary purpose of developing this questionnaire is to examine how well it can potentially identify patients with actinic keratoses. However, since AK is associated with significant detriment to quality of life for validity/reliability assessment, the investigators propose to give a compilation of four self-assessment questionnaires (not specific to AK but validated for skin health in general) to subjects with at least one actinic keratosis and age- and sex- matched participants without AKs, defined as the control population. These will include the SKINDEX-16, the DLQI and the Skin Health Calculator, as well as a questionnaire composed of items specific to predisposition to AKs to be able to better assess the discriminatory power of the questionnaire.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Male or female, age 18 years or older being seen in a dermatology clinic
- Informed consent of participation must be given by subject
- Inability to complete all study questionnaires.
- Subjects who are unable to read and write English
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients with Actinic Keratosis AKRQ questionnaire Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire. Patients with Actinic Keratosis Skindex-16, DLQI, Skin Health Calculator Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire. Patients without actinic keratosis AKRQ questionnaire Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire. Patients without actinic keratosis Skindex-16, DLQI, Skin Health Calculator Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire.
- Primary Outcome Measures
Name Time Method Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosis Baseline We are developing an actinic keratosis risk assessment questionnaire and is designed to distinguish patients who have a higher likelihood of having a diagnosis of actinic keratosis. The outcome measure is the difference in scores between those with actinic keratosis and those without.
- Secondary Outcome Measures
Name Time Method The correlation between the AKRQ and Skin Health Calculator scores. Baseline The Skin health calculator is a validated instrument. We will report how well our new instrument correlates with the Skin Health Calculator
Correlation between AKRQ and DLQI scores Baseline The DLQI is a validated instrument. We will report how well our new instrument correlates with the DLQI.
The correlation between AKRQ and Skindex-16 scores Baseline The Skindex-16 is a validated instrument. We will report how well our new instrument correlates with the Skindex-16.
Trial Locations
- Locations (1)
Wake Forest Health Sciences Dermatology
🇺🇸Winston-Salem, North Carolina, United States