Skin Toxicities
Conditions
Keywords
EGFRI, HRQL, Quality of Life, Development of a standardized HRQL instrument for anti-EGFR therapy induced
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.
Interventions
OTHERQuestionnaire
Administered questionnaire
Sponsors
Northwestern University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| 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 | 20 |
| Total | 32 |
Baseline characteristics
| Characteristic | Expert Interviews | Patient Interviews | Total |
|---|---|---|---|
| Age, Continuous | 39.2 years | 57.0 years | 50.3 years |
| Sex: Female, Male Female | 7 Participants | 15 Participants | 22 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 20 |
| serious Total, serious adverse events | 0 / 12 | 0 / 20 |
Outcome results
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.
Time frame: at time of questionnaire
Population: Additional items that were variably collected and recorded have been omitted from the data set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition burns or stings | 2.70 units on a scale | Standard Deviation 0.48 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin hurts | 2.70 units on a scale | Standard Deviation 0.48 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My eyes are dry | 1.90 units on a scale | Standard Deviation 0.14 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition affects how well I sleep | 2.40 units on a scale | Standard Deviation 0.84 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin is flaky and dry | 1.70 units on a scale | Standard Deviation 0.67 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin itches | 2.20 units on a scale | Standard Deviation 0.63 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition makes it work/hobbies hard | 2.20 units on a scale | Standard Deviation 0.79 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My fingers/toes hurt | 2.40 units on a scale | Standard Deviation 0.7 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | I am satisfied with the condition of my skin | 1.60 units on a scale | Standard Deviation 1.17 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | I am bothered by increased facial/eyelash hair | 1.70 units on a scale | Standard Deviation 0.67 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition makes me feel depressed | 2.60 units on a scale | Standard Deviation 0.7 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition affects my social life | 2.80 units on a scale | Standard Deviation 0.42 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition bothers me | 1.80 units on a scale | Standard Deviation 1.03 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition makes daily life difficult | 2.00 units on a scale | Standard Deviation 0.67 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | I am frustrated by my skin condition | 1.60 units on a scale | Standard Deviation 0.84 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition affects my mood | 1.80 units on a scale | Standard Deviation 0.92 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | I tend to do things by myself because of my skin | 1.90 units on a scale | Standard Deviation 0.99 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | I tend to stay at home because of my skin | 2.60 units on a scale | Standard Deviation 0.52 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | I experience pain in certain body parts | 1.90 units on a scale | Standard Deviation 0.74 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin makes showing affection difficult | 1.90 units on a scale | Standard Deviation 1.1 |
| Expert Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin is a problem for the people I love | 2.00 units on a scale | Standard Deviation 0.82 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition makes me feel depressed | 1.88 units on a scale | Standard Deviation 1.11 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition burns or stings | 2.41 units on a scale | Standard Deviation 0.94 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | I experience pain in certain body parts | 1.50 units on a scale | Standard Deviation 0.97 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin hurts | 2.29 units on a scale | Standard Deviation 1.18 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition affects my social life | 1.88 units on a scale | Standard Deviation 1.09 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My eyes are dry | 2.14 units on a scale | Standard Deviation 1.17 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | I tend to do things by myself because of my skin | 1.71 units on a scale | Standard Deviation 1.14 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition affects how well I sleep | 2.13 units on a scale | Standard Deviation 1.13 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition bothers me | 1.88 units on a scale | Standard Deviation 0.89 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin is flaky and dry | 2.00 units on a scale | Standard Deviation 1.15 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin is a problem for the people I love | 1.68 units on a scale | Standard Deviation 1.31 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin itches | 2.00 units on a scale | Standard Deviation 1.17 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition makes daily life difficult | 1.80 units on a scale | Standard Deviation 1.08 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition makes it work/hobbies hard | 2.00 units on a scale | Standard Deviation 1.1 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | I tend to stay at home because of my skin | 1.60 units on a scale | Standard Deviation 1.3 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My fingers/toes hurt | 2.00 units on a scale | Standard Deviation 1.07 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | I am frustrated by my skin condition | 1.75 units on a scale | Standard Deviation 1.13 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | I am satisfied with the condition of my skin | 1.94 units on a scale | Standard Deviation 0.85 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin makes showing affection difficult | 1.46 units on a scale | Standard Deviation 1.2 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | I am bothered by increased facial/eyelash hair | 1.93 units on a scale | Standard Deviation 1.22 |
| Patient Interviews | Qualitative Data From Patients and Experts to Measure Anti-EGFR Therapy-specific Health-related Quality of Life (HRQL) | My skin condition affects my mood | 1.71 units on a scale | Standard Deviation 1.18 |