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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest University
ClinicalTrials.gov Identifier:
NCT01444989
First received: September 29, 2011
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Actinic Keratosis
Other: AKRQ questionnaire
Other: Skindex-16, DLQI, Skin Health Calculator

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Development and Validation of a Quality of Life Instrument for Actinic Keratosis

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosis [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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:
  • Correlation between AKRQ and DLQI scores [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The Skin health calculator is a validated instrument. We will report how well our new instrument correlates with the Skin Health Calculator


Enrollment: 150
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients without actinic keratosis
Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire.
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 with Actinic Keratosis
Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444989

Locations
United States, North Carolina
Wake Forest Health Sciences Dermatology
Winston Salem, North Carolina, United States, 27104
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Steven R Feldman, MD, PhD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Steven R. Feldman, Professor of Dermatology, Wake Forest University
ClinicalTrials.gov Identifier: NCT01444989     History of Changes
Other Study ID Numbers: 00017619
Study First Received: September 29, 2011
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
"Sun spots"
"Pre-cancerous skin lesion"

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Neoplasms
Precancerous Conditions
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014