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NCT01015326 · ClinicalTrials.gov registry record
Development of Dermatology-related Quality of Life Assessment in Patients Treated With Epidermal Growth Factor Receptor (EGFR) Inhibitors
A clinical trial, sponsored by Northwestern University.
- Completed
- Registry status
- 32
- Enrollment target
NCT01015326: Completed study, sponsored by Northwestern University.
NCT01015326 is a clinical trial that has completed, run by Northwestern University. The registered enrollment target is 32 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01015326 has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- 32 participants
- Enrollment target
Study 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.
Primary Outcome
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,
Interventions
- OTHER Questionnaire
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2006-07 |
| Est. Completion | 2009-11 |
What the finished NCT01015326 record still lists
NCT01015326 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 32 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Questionnaire is the first listed.
NCT01015326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01015326 about?
NCT01015326 is a clinical study titled "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 to...
What is the current status of trial NCT01015326?
This trial is currently completed. The enrollment target is 32 participants. The study started on 2006-07. Estimated completion is 2009-11.
What interventions are being tested in trial NCT01015326?
The interventions under investigation include: Questionnaire (OTHER).
Who is sponsoring clinical trial NCT01015326?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
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