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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01444989
First Posted: October 3, 2011
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences ( Wake Forest University )
September 29, 2011
October 3, 2011
November 6, 2017
September 2011
December 2011   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01444989 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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
Same as current
Not Provided
Not Provided
 
Development and Validation of a Quality of Life Instrument for Actinic Keratosis
Development and Validation of a Quality of Life Instrument for Actinic Keratosis

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Actinic Keratosis
  • Other: AKRQ questionnaire
    The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors
  • Other: Skindex-16, DLQI, Skin Health Calculator
    These are all previously validated questionnaires
  • Experimental: Patients without actinic keratosis
    Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire.
    Interventions:
    • Other: AKRQ questionnaire
    • Other: Skindex-16, DLQI, Skin Health Calculator
  • Experimental: Patients with Actinic Keratosis
    Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire.
    Interventions:
    • Other: AKRQ questionnaire
    • Other: Skindex-16, DLQI, Skin Health Calculator
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
March 2012
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01444989
00017619
No
Not Provided
Not Provided
Wake Forest University Health Sciences ( Wake Forest University )
Wake Forest University
Not Provided
Principal Investigator: Steven R Feldman, MD, PhD Wake Forest University Health Sciences
Wake Forest University Health Sciences
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP