Development and Validation of a Quality of Life Instrument for Actinic Keratosis (AKRQ)

Wake Forest University (WFU)

Status: Completed

Conditions: Actinic Keratosis

Treatments: Other: AKRQ questionnaire; Other: Skindex-16, DLQI, Skin Health Calculator

Study type: Interventional

Funder types: Other

Identifiers

NCT01444989

IRB00017619

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, age 18 years or older being seen in a dermatology clinic
• Informed consent of participation must be given by subject

Exclusion criteria

• Inability to complete all study questionnaires.
• Subjects who are unable to read and write English

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Patients without actinic keratosis

Experimental group

Description:

Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire.

Treatment:

Other: Skindex-16, DLQI, Skin Health Calculator

Other: AKRQ questionnaire

Patients with Actinic Keratosis

Experimental group

Description:

Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire.

Treatment:

Other: Skindex-16, DLQI, Skin Health Calculator

Other: AKRQ questionnaire