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.
Time Perspective: Prospective
Psychometric properties of the FACT-EGFRI 18
127 days from registration
Laurence H. Baker, DO, FACOI
University of Michigan Cancer Center
United States: Federal Government
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|USC/Norris Comprehensive Cancer Center and Hospital||Los Angeles, California 90033-0804|
|City of Hope Comprehensive Cancer Center||Duarte, California 91010|
|Blumenthal Cancer Center at Carolinas Medical Center||Charlotte, North Carolina 28232-2861|
|Winthrop University Hospital||Mineola, New York 11501|
|Loma Linda University Cancer Institute at Loma Linda University Medical Center||Loma Linda, California 92354|
|Via Christi Cancer Center at Via Christi Regional Medical Center||Wichita, Kansas 67214|
|Mission Hospitals - Memorial Campus||Asheville, North Carolina 28801|
|Presbyterian Cancer Center at Presbyterian Hospital||Charlotte, North Carolina 28233-3549|
|Wayne Memorial Hospital, Incorporated||Goldsboro, North Carolina 27534|
|Decatur Memorial Hospital Cancer Care Institute||Decatur, Illinois 62526|
|Cancer Center of Kansas, PA - Dodge City||Dodge City, Kansas 67801|
|Cancer Center of Kansas, PA - Chanute||Chanute, Kansas 66720|
|Cancer Center of Kansas - Fort Scott||Fort Scott, Kansas 66701|
|Cancer Center of Kansas-Independence||Independence, Kansas 67301|
|Cancer Center of Kansas, PA - Kingman||Kingman, Kansas 67068|
|Lawrence Memorial Hospital||Lawrence, Kansas 66044|
|Cancer Center of Kansas, PA - Liberal||Liberal, Kansas 67905|
|Cancer Center of Kansas, PA - Newton||Newton, Kansas 67114|
|Cancer Center of Kansas, PA - Parsons||Parsons, Kansas 67357|
|Cancer Center of Kansas, PA - Pratt||Pratt, Kansas 67124|
|Cancer Center of Kansas, PA - Salina||Salina, Kansas 67401|
|Cancer Center of Kansas, PA - Wellington||Wellington, Kansas 67152|
|Cancer Center of Kansas, PA - Wichita||Wichita, Kansas 67214|
|Associates in Womens Health, PA - North Review||Wichita, Kansas 67208|
|Cancer Center of Kansas, PA - Medical Arts Tower||Wichita, Kansas 67208|
|Cancer Center of Kansas, PA - Winfield||Winfield, Kansas 67156|
|Pardee Memorial Hospital||Hendersonville, North Carolina 28791|
|High Point Regional Hospital||High Point, North Carolina 27261|