The development of a Functional Assessment of Cancer Therapy (FACT) questionnaire to assess dermatologic symptoms associated with epidermal growth factor receptor inhibitors (FACT-EGFRI-18).

Purpose: Dermatologic toxicities from epidermal growth factor receptor inhibitors (EGFRIs) are common, disrupt health-related quality of life (HRQL), and lead to dose reduction or discontinuation of potentially life-saving cancer therapy. The Functional Assessment of Cancer Therapy (FACT)-EGFRI was developed to measure HRQL among patients receiving EGFRIs.

Methods: The FACT-EGFRI was developed through the triangulation approach using the established functional assessment of chronic illness therapy method of patient questionnaire construction. This included literature review, qualitative data collection and analysis, and quantitative survey data collection on candidate items to identify the most important items related to EGFRI-induced dermatologic toxicities according to patients receiving EGFRIs and expert clinicians.

Results: Twelve expert clinicians and 20 patients were interviewed for the initial questionnaire development. Dermatologic symptoms associated with epidermal growth factor receptor inhibitors endorsed as high priority by both patients and oncologist experts were selected. The final version includes 18 items which assess the physical, emotional, social, and functional impact that skin, nail, and hair toxicities have on patients' HRQL.

Conclusions: The FACT-EGFRI-18 measures the severity of patient-reported EGFRI-induced dermatologic toxicities and effects on HRQL and was developed using qualitative data from patients and expert clinicians. Further validation is underway. The FACT-EGFRI-18 may be useful for clinicians and researchers to quantify dermatologic toxicities from the patient perspective in standard clinical care, evaluate the effectiveness of interventions to prevent or reduce dermatologic toxicities, and to guide treatment decision making.