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

NCT01015326 | Completed Results DMC

• 1 other identifier: 1918-004
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Toxicities

Keywords

EGFRI; HRQL; Quality of Life; Development of a standardized HRQL instrument for anti-EGFR therapy induced

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

Questionnaire OTHER

Administered questionnaire

Expert Interviews

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Mandy Browning
• Organization: Northwestern University

mandybrowning2015@u.northwestern.edu

312-695-6829

Study Officials

• Dennis P West, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Dermatology and Pediatrics

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 18, 2009
• Study Start: July 1, 2006
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: January 5, 2015
• Results First Posted: April 8, 2013

Record last verified: 2014-12

Locations

US (1)