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S1013: A Prospective Study of Epidermal Growth Factor Receptor (HER-1/EGFR) Inhibitor-Induced Dermatologic Toxicity: Validation of the Functional Assessment of Cancer Therapy-EGFRI 18(FACT-EGFRI 18) Questionnaire for EGFRI-Induced Skin Toxicities
- To establish psychometric properties for the Functional Assessment of Cancer Therapy
Epidermal Growth Factor Receptor Inhibitor (FACT-EGFRI 18) module (based on criterion
validity, known group's validity, internal consistency reliability, and responsiveness
to change) as a patient-reported outcome (PRO) measure of EGFRI-induced skin-related
- To document minimally important differences over time for the FACT-EGFRI 18 by comparing
mean changes in this PRO measure to the patient's direct assessment of change using two
anchor items (change in skin condition severity and impact).
- To examine the association between toxicity profiles (severity and time to onset), and
treatment profiles (e.g., delays and discontinuation) and the FACT-EGFRI 18 scores.
- To assess degree of concordance between FACT-EGFRI 18 ratings and study site physician
CTCAE Version 4.0 EGFRI-Induced Dermatologic Toxicity Grading Assessment ratings.
- To evaluate feasibility outcomes.
OUTLINE: This is a multicenter study.
Patients complete the S1013 Functional Assessment of Cancer Therapy Epidermal Growth Factor
Receptor Inhibitor (FACT-EGFRI 18) at baseline and prior to beginning therapy and clinical
assessment. Patients also complete FACT-EGFRI 18 and the Changes in Skin Symptoms on days 1*,
8**, 15, 22, 29, 36, 43, 71, 99, and 127. Patients who do not develop any grade of
papulopustular rash within 42 days are removed from study.
Investigators performing the patients' clinical assessment complete the EGFRI-Induced
Dermatologic Toxicity Grading Assessment on days 1, 8, 15, 22, 29, 36, 43, 71, 99, and 127,
and the Treatment Form assessment on days 22, 43, 71, 99, and 127. Nurses or clinical trial
administrators (CRA) also complete the S1013 Cover Sheet for Patient Complete Questionnaires
accompanying the FACT-EGFRI 18 patients' questionnaires at each schedule assessment.
NOTE: *Patients start EGFRI therapy.
NOTE: **Change in Skin Symptoms questionnaire starts on Day 8.
Inclusion and Exclusion Criteria
- Patients must have a diagnosis of colorectal or lung cancer and be planning to receive one of the following epidermal growth factor receptor (HER1/EGFR) inhibitor therapies listed below for at least 6 weeks:
- Cetuximab 400 mg/m
- University of Southern California, Los Angeles, California, 90033
- City of Hope, Duarte, California, 91010
- Loma Linda University Medical Center, Loma Linda, California, 92354
- Southwest Oncology Group, San Antonio, Texas, 78245
- Louisiana State University Sciences Center- Monroe, Monroe, Louisiana, 71210
- Northern Michigan Regional Hospital, Petoskey, Michigan, 49770