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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dennis West, Northwestern University
ClinicalTrials.gov Identifier:
NCT01015326
First received: November 6, 2009
Last updated: February 26, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Skin Toxicities
 Other: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Urogastrone
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) [ Time Frame: at time of questionnaire ] [ Designated as safety issue: No ]
    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."


Enrollment: 32
Study Start Date: July 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01015326

Locations
United States, Illinois
Northwestern University Feinberg School of Medicine, Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Dennis P West, PhD Northwestern University
  More Information

No publications provided

Responsible Party: Dennis West, Professor in Dermatology and Pediatrics, Northwestern University
ClinicalTrials.gov Identifier: NCT01015326     History of Changes
Other Study ID Numbers: 1918-004
Study First Received: November 6, 2009
Results First Received: February 26, 2013
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
EGFRI
HRQL
Quality of Life
Development of a standardized HRQL instrument for anti-EGFR therapy induced

Additional relevant MeSH terms:
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013