An observational study in Colorectal Cancer, Dermatologic Complications and Lung Cancer, sponsored by SWOG Cancer Research Network. Completed at 113 sites in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2022-12-15.
Sponsored by SWOG Cancer Research Network · Observational
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.
OBJECTIVES:
Primary
Secondary
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 146 is below the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Limited institutions from the SWOG membership.
DISEASE CHARACTERISTICS:
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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 · Procedure: psychosocial assessment and care · Procedure: quality-of-life assessment
Will be given by questionnaire
Will be given by questionnaire
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
Showing the first 100 of 113 sites.
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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SWOG Cancer Research Network