S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride
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|ClinicalTrials.gov Identifier: NCT01416688|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2011
Last Update Posted : December 15, 2017
RATIONALE: Questionnaires that patients can use to assess skin toxicities related to treatment may help identify the intermediate-and long-term effects of cetuximab, panitumumab, or erlotinib hydrochloride.
PURPOSE: This trial studies the validation of a cancer questionnaire for skin toxicities in patients with colorectal or lung cancer receiving cetuximab, panitumumab, or erlotinib hydrochloride.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Dermatologic Complications Lung Cancer Therapy-related Toxicity||Procedure: assessment of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
- 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 toxicity.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||140 participants|
|Official Title:||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|
|Study Start Date :||November 2011|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||April 2018|
Observation and Questionnaires
Patients will be given questionnaires for the assessment of therapy complications, psychosocial assessment and care, and quality-of-life assessment.
Procedure: assessment of therapy complications
Will be given by questionnaireProcedure: psychosocial assessment and care
Will be given by questionnaireProcedure: quality-of-life assessment
Will be given by questionnaire
- Psychometric properties of the FACT-EGFRI 18 [ Time Frame: 127 days from registration ]
- Change in severity and impact of skin symptoms [ Time Frame: 127 days from registration ]
- Agreement between site physician ratings with the CTCAE Version 4 and patient ratings for the FACT-EGFRI 18 items [ Time Frame: 127 days from registration ]
- Associations between toxicity profile and treatment profiles [ Time Frame: 127 days from registration ]
- Feasibility as measured by accrual, time to specified accrual, time to complete forms [ Time Frame: 2 years from study activation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416688
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|Principal Investigator:||Laurence H. Baker, DO, FACOI||University of Michigan Cancer Center|