Trial Outcomes & Findings for Development of Dermatology-related Quality of Life Assessment in Patients Treated With Epidermal Growth Factor Receptor (EGFR) Inhibitors (NCT NCT01015326)
NCT ID: NCT01015326
Last Updated: 2015-01-05
Results Overview
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."
Recruitment status
COMPLETED
Target enrollment
32 participants
Primary outcome timeframe
at time of questionnaire
Results posted on
2015-01-05
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
20
|
|
Overall Study
COMPLETED
|
11
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of Dermatology-related Quality of Life Assessment in Patients Treated With Epidermal Growth Factor Receptor (EGFR) Inhibitors
Baseline characteristics by cohort
| Measure |
Expert Interviews
n=12 Participants
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
|
Patient Interviews
n=20 Participants
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
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.2 years
n=5 Participants
|
57.0 years
n=7 Participants
|
50.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at time of questionnairePopulation: Additional items that were variably collected and recorded have been omitted from the data set.
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."
Outcome measures
| Measure |
Expert Interviews
n=11 Participants
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
|
Patient Interviews
n=18 Participants
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
|
|---|---|---|
|
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
|
2.41 units on a scale
Standard Deviation 0.94
|
|
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
|
2.29 units on a scale
Standard Deviation 1.18
|
|
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
|
2.14 units on a scale
Standard Deviation 1.17
|
|
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
|
2.13 units on a scale
Standard Deviation 1.13
|
|
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
|
2.00 units on a scale
Standard Deviation 1.15
|
|
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
|
2.00 units on a scale
Standard Deviation 1.17
|
|
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
|
2.00 units on a scale
Standard Deviation 1.10
|
|
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 0.70
|
2.00 units on a scale
Standard Deviation 1.07
|
|
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
|
1.94 units on a scale
Standard Deviation 0.85
|
|
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
|
1.93 units on a scale
Standard Deviation 1.22
|
|
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 0.70
|
1.88 units on a scale
Standard Deviation 1.11
|
|
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
|
1.88 units on a scale
Standard Deviation 1.09
|
|
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
|
1.88 units on a scale
Standard Deviation 0.89
|
|
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
|
1.80 units on a scale
Standard Deviation 1.08
|
|
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
|
1.75 units on a scale
Standard Deviation 1.13
|
|
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
|
1.71 units on a scale
Standard Deviation 1.18
|
|
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
|
1.71 units on a scale
Standard Deviation 1.14
|
|
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
|
1.60 units on a scale
Standard Deviation 1.30
|
|
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
|
1.50 units on a scale
Standard Deviation 0.97
|
|
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 1.10
|
1.46 units on a scale
Standard Deviation 1.20
|
|
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
|
1.68 units on a scale
Standard Deviation 1.31
|
Adverse Events
Expert Interviews
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patient Interviews
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place