Development and Validation of a Quality of Life Instrument for Actinic Keratosis

NCT ID: NCT01444989

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-03-31

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.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients without actinic keratosis

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

Group Type: EXPERIMENTAL

AKRQ questionnaire

Intervention Type: OTHER

The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors

Skindex-16, DLQI, Skin Health Calculator

Intervention Type: OTHER

These are all previously validated questionnaires

Patients with Actinic Keratosis

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

Group Type: EXPERIMENTAL

AKRQ questionnaire

Intervention Type: OTHER

The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors

Skindex-16, DLQI, Skin Health Calculator

Intervention Type: OTHER

These are all previously validated questionnaires

Interventions

AKRQ questionnaire

The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors

Intervention Type: OTHER

Skindex-16, DLQI, Skin Health Calculator

These are all previously validated questionnaires

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wake Forest University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven R Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest Health Sciences Dermatology

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00017619

Identifier Type: -

Identifier Source: org_study_id