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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | Administered questionnaire |
| |
| Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with an EGFRI and referred to a specialized dermatology clinic for skin rash management.
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| Name | Affiliation | Role |
|---|---|---|
| Dennis P West, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine, Department of Dermatology | Chicago | Illinois | 60611 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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 : Administered questionnaire |
| FG001 | 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 through interview and questionnaire to rate items according to how important they are to the patient's health-related quality of life (HRQL). Questionnaire : Administered questionnaire |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 health-related quality of life (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 : Administered questionnaire |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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." | Additional items that were variably collected and recorded have been omitted from the data set. | Posted | Mean | Standard Deviation | units on a scale | at time of questionnaire |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 health-related quality of life (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 : Administered questionnaire |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mandy Browning | Northwestern University | 312-695-6829 | mandybrowning2015@u.northwestern.edu |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Other |
Administered questionnaire |
|
| BG001 | 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 health-related quality of life (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 : Administered questionnaire |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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 health-related quality of life (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 : Administered questionnaire |
| OG001 | 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 health-related quality of life (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 : Administered questionnaire |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | 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 health-related quality of life (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 : Administered questionnaire | 0 | 20 | 0 | 20 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |