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

NCT ID: NCT01015326

Last Updated: 2015-01-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

32 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Skin Toxicities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Questionnaire

Intervention Type OTHER

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.

Questionnaire

Intervention Type OTHER

Administered questionnaire

Interventions

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Questionnaire

Administered questionnaire

Intervention Type OTHER

Questionnaire

Administered questionnaire

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Dennis West

Professor in Dermatology and Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dennis P West, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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1918-004

Identifier Type: -

Identifier Source: org_study_id

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