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

August 13, 2018 updated by: Wake Forest University

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104
        • Wake Forest Health Sciences Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients without actinic keratosis
Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire.
The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors
These are all previously validated questionnaires
Experimental: Patients with Actinic Keratosis
Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire.
The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors
These are all previously validated questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosis
Time Frame: 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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between AKRQ and DLQI scores
Time Frame: Baseline
The DLQI is a validated instrument. We will report how well our new instrument correlates with the DLQI.
Baseline
The correlation between AKRQ and Skindex-16 scores
Time Frame: Baseline
The Skindex-16 is a validated instrument. We will report how well our new instrument correlates with the Skindex-16.
Baseline
The correlation between the AKRQ and Skin Health Calculator scores.
Time Frame: Baseline
The Skin health calculator is a validated instrument. We will report how well our new instrument correlates with the Skin Health Calculator
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

September 30, 2011

First Posted (Estimate)

October 3, 2011

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 13, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00017619

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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