Development and Validation of a Quality of Life Instrument for Actinic Keratosis (AKRQ)
Primary Purpose
Actinic Keratosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AKRQ questionnaire
Skindex-16, DLQI, Skin Health Calculator
Sponsored by
About this trial
This is an interventional other trial for Actinic Keratosis focused on measuring "Sun spots", "Pre-cancerous skin lesion"
Eligibility 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
Sites / Locations
- Wake Forest Health Sciences Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patients without actinic keratosis
Patients with Actinic Keratosis
Arm Description
Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire.
Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire.
Outcomes
Primary Outcome Measures
Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosis
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
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
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.
The Skin health calculator is a validated instrument. We will report how well our new instrument correlates with the Skin Health Calculator
Full Information
NCT ID
NCT01444989
First Posted
September 29, 2011
Last Updated
August 13, 2018
Sponsor
Wake Forest University
1. Study Identification
Unique Protocol Identification Number
NCT01444989
Brief Title
Development and Validation of a Quality of Life Instrument for Actinic Keratosis
Acronym
AKRQ
Official Title
Development and Validation of a Quality of Life Instrument for Actinic Keratosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis
Keywords
"Sun spots", "Pre-cancerous skin lesion"
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients without actinic keratosis
Arm Type
Experimental
Arm Description
Patients with out the diagnosis of actinic keratosis will receive the experimental questionnaire.
Arm Title
Patients with Actinic Keratosis
Arm Type
Experimental
Arm Description
Patients with the diagnosis of actinic keratosis will receive the experimental questionnaire.
Intervention Type
Other
Intervention Name(s)
AKRQ questionnaire
Intervention Description
The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors
Intervention Type
Other
Intervention Name(s)
Skindex-16, DLQI, Skin Health Calculator
Intervention Description
These are all previously validated questionnaires
Primary Outcome Measure Information:
Title
Difference in questionnaire score in patients with Actinic keratosis and with out actinic keratosis
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Correlation between AKRQ and DLQI scores
Description
The DLQI is a validated instrument. We will report how well our new instrument correlates with the DLQI.
Time Frame
Baseline
Title
The correlation between AKRQ and Skindex-16 scores
Description
The Skindex-16 is a validated instrument. We will report how well our new instrument correlates with the Skindex-16.
Time Frame
Baseline
Title
The correlation between the AKRQ and Skin Health Calculator scores.
Description
The Skin health calculator is a validated instrument. We will report how well our new instrument correlates with the Skin Health Calculator
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest Health Sciences Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Development and Validation of a Quality of Life Instrument for Actinic Keratosis
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