Development of Dermatology-related Quality of Life Assessment in Patients Treated With Epidermal Growth Factor Receptor (EGFR) Inhibitors (FAST)

Development of a Functional Assessment of Side-effects to Therapy (FAST) Questionnaire to Assess Dermatology-Related Quality of Life in Patients Treated With EGFR Inhibitors: The FAST-EGFR Inhibitors: The FAST-EGFRI and Development of an Investigator Grading System: The Skin and Eye Reactions to Inhibitors of EGFR (SERIES) Score

Epidermal Growth Factor Receptor Inhibitors (EGFRI) are associated with skin toxicities. Clinical experience suggests that skin toxicities interfere with health related quality of life (HRQL) and may interfere with treatment adherence. No systematic investigations of EGFRI-associated dermatologic toxicities and impact on HRQL have been reported. No patient-reported outcome measures exist to capture the unique concerns of oncology patients who experience EGFRI-associated dermatologic toxicities.

The purpose of this study is to develop a patient-reported outcomes measure to assess dermatologic-related symptoms burden and health-related quality of life among patients receiving an EGFRI, and to develop a grading system for EGFRI-associated dermatologic toxicities.

Study Overview

• Status: Completed
• Conditions: Skin Toxicities
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with an EGFRI and referred to a specialized dermatology clinic for skin rash management.

Description

Inclusion Criteria:

• Undergoing anti-EGFR cancer therapy
• Over 18 years old

Exclusion Criteria:

• Unable to complete the questionnaire
• Unable to follow instructions or give consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Expert Interviews; Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to HRQL in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.	Other: Questionnaire; Administered questionnaire
Patient Interviews; Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their HRQL to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.	Other: Questionnaire; Administered questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL)	Patients were asked "How important is this symptoms or concern to your quality of life?" They were given a series of items (listed in the table) and instructed to assign each item a numerical value of 0 to 3, where 0 is equivalent to "not at all important" and 3 is equivalent to "extremely important." Experts were asked "How important is this symptom or concern to patients' quality of life?" They were given the same series of items and instructed to assign each item a numerical value of 0 to 3, where 0 is equivalent to "not at all important" and 3 is equivalent to "extremely important." For each item, a mean score was calculated using the values assigned to that item from all patients, and a second mean score was calculated using the values assigned to that item from all experts. An item's mean score may range from 0 to 3, where 0 is equivalent to "not at all important to quality of life" and where 3 is equivalent to "extremely important to quality of life."	at time of questionnaire

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Dennis P West, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: November 6, 2009
• First Submitted That Met QC Criteria: November 16, 2009
• First Posted (Estimate): November 18, 2009

Study Record Updates

• Last Update Posted (Estimate): January 5, 2015
• Last Update Submitted That Met QC Criteria: December 11, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Quality of Life; EGFRI; HRQL; Development of a standardized HRQL instrument for anti-EGFR therapy induced
• Other Study ID Numbers: 1918-004