We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
A prospective study to validate the functional assessment of cancer therapy (FACT) for epidermal growth factor receptor inhibitor (EGFRI)-induced dermatologic toxicities FACT-EGFRI 18 questionnaire: SWOG S1013.
- Authors
Wong, Siu-Fun; Unger, Joseph M.; Wade III, James L.; Wagner, Lynne I.; Lacouture, Mario E.; Humphries, Keisha C.; Moseley, Anna; Arnold, Kathryn; Velasco, Mario R.; Floyd, Justin D.; Esparaz, Benjamin T.; Barzi, Afsaneh; Lenz, Heinz-Josef; Koczywas, Marianna; Dakhil, Shaker; Burton, Gary V.; Fisch, Michael J.; Henry, N. Lynn; Hershman, Dawn L.; Moinpour, Carol M.
- Abstract
Background: Papulopustular rash is a common class effect of epidermal growth factor receptor inhibitors (EGFRI) that can affect patients' health-related quality of life and cause disruptions to treatment. SWOG S1013 (NCT01416688) is a multi-center study designed to validate the Functional Assessment of Cancer Therapy EGFRI 18 (FACT-EGFRI 18) using 7-items from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 to assess EGFRI-induced skin-related toxicities and their impact on functional status. Methods: Patients with a diagnosis of colorectal or lung cancer to receive EGFRI therapies for at least 6 weeks were enrolled. Patient self-assessments using the FACT-EGFRI 18 were completed prior to undergoing CTCAE assessment by trained clinicians at baseline, weekly × 6, and then monthly × 3. The psychometric properties of the FACT-EGFRI 14 (skin toxicity items only) and 18 (plus 2 nail and 2 hair items) were established based on criterion validity, known groups validity, internal consistency reliability, and responsiveness to change. Results: Of the 146 registered patients, 124 were evaluable. High Cronbach's alpha (> 0.70) for both FACT-EGFRI 14 and FACT-EGFRI 18 scores across assessment times were observed. Although agreement (i.e. criterion validity) between individual and summary scales of the FACT-EGFRI 18 for assessing skin toxicity was good, agreement with the clinician-reported CTCAE was only fair. The minimal important difference was determined to be 3 points. The results also demonstrated responsiveness to symptom change. Discussion: Based on the results of this multi-center validation study, the FACT-EGFRI 18 patient-reported outcome instrument provided data from the patient's perspective yielding unique information as well as complementing clinician-rated CTCAE grades, especially for the symptoms of pain, pruritus, and paronychia. Conclusions: Good to excellent psychometric properties for the FACT-EGFRI 18 were demonstrated, supporting further use of this patient-reported outcomes measure. Additional validation with a more diverse group of patients should be conducted.
- Subjects
FUNCTIONAL assessment; CANCER treatment; DRUG toxicity; EPIDERMAL growth factor receptors; COLON cancer; LUNG cancer; DRUG side effects; RESEARCH; SKIN diseases; RESEARCH evaluation; RESEARCH methodology evaluation; FUNCTIONAL status; RESEARCH methodology; LUNG tumors; HEALTH outcome assessment; RISK assessment; COLORECTAL cancer; PSYCHOMETRICS; CRONBACH'S alpha; QUESTIONNAIRES; RESEARCH funding; QUALITY of life; DRUG eruptions; LONGITUDINAL method
- Publication
Journal of Patient-Reported Outcomes, 2020, Vol 4, Issue 1, p1
- ISSN
2509-8020
- Publication type
Article
- DOI
10.1186/s41687-020-00220-x