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OpenTrials
Completed

NCT Number: NCT01015326

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

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.

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Key information

Conditions

Skin Toxicities

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire

Other

Administered questionnaire

Primary outcomes

  1. Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL)

    Time frame: at time of questionnaire

    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."

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study 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

Acronym: FAST

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 18, 2009
Registry last updated
Jan 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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