S1013: Validation of Cancer Questionnaire for Skin Toxicities in Patients With Colorectal Cancer or Lung Cancer Receiving Cetuximab, Panitumumab, or Erlotinib Hydrochloride

Completed

• Conditions: Therapy-related Toxicity; Colorectal Cancer; Dermatologic Complications; Lung Cancer

• Registration Number: NCT01416688
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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 Timeline

• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-12
• Study First Posted: 2011-08-15
• Study Start: 2011-11-15
• Primary Completion: 2018-05-01
• Study Completion: 2019-04-08
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-14
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psychometric properties of the FACT-EGFRI 18	127 days from registration

Secondary Outcome Measures

Name	Time	Method
Feasibility as measured by accrual, time to specified accrual, time to complete forms	2 years from study activation
Change in severity and impact of skin symptoms	127 days from registration
Agreement between site physician ratings with the CTCAE Version 4 and patient ratings for the FACT-EGFRI 18 items	127 days from registration
Associations between toxicity profile and treatment profiles	127 days from registration

Trial Locations

Locations (113)

University of Arizona Cancer Center-North Campus; 🇺🇸 Tucson, Arizona, United States

The University of Arizona Medical Center-University Campus; 🇺🇸 Tucson, Arizona, United States

East Bay Radiation Oncology Center; 🇺🇸 Castro Valley, California, United States

City of Hope Comprehensive Cancer Center; 🇺🇸 Duarte, California, United States

Epic Care-Dublin; 🇺🇸 Dublin, California, United States

Bay Area Breast Surgeons Inc; 🇺🇸 Emeryville, California, United States

Epic Care Partners in Cancer Care; 🇺🇸 Emeryville, California, United States

UC San Diego Moores Cancer Center; 🇺🇸 La Jolla, California, United States

Loma Linda University Medical Center; 🇺🇸 Loma Linda, California, United States

Los Angeles County-USC Medical Center; 🇺🇸 Los Angeles, California, United States

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