Trial Outcomes & Findings for Home Away From Home - Quality of Life Surveys (NCT NCT02777021)
NCT ID: NCT02777021
Last Updated: 2019-12-23
Results Overview
1 Course of Chemotherapy (Approximately 30-40 days). The primary outcome of interest was patient health-related quality of life (HRQOL) measured using the acute PedsQL™ 4.0 Generic Core Scales.31 These scales use a 7-day time frame. The multidimensional assessment includes items in four domains: physical functioning, emotional functioning, social functioning, and school functioning. Respondents document responses to each question using a 5-point Likert scale anchored by never a problem (0) to almost always a problem (4). PedsQL™ items were reverse scored and linearly transformed to a scale of 0 to 100 such that higher scores reflect better HRQOL.
COMPLETED
154 participants
PedsQL assessments were administered at two points - at the start of the study-contributed chemotherapy course prior to the patient becoming neutropenic (baseline) and again within the period between neutropenia resolution (follow-up); follow-up reported.
2019-12-23
Participant Flow
Participant milestones
| Measure |
Early Discharge Patients
Patients receiving or having received chemotherapy for AML who are discharged to outpatient management within 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.
HRQOL questions will be scored on a 5-point Likert response scale (0=never a problem to 4=almost always a problem). The total score includes a 23 item multidimensional core (physical, emotional, social and school functioning); an 18 item multidimensional fatigue scale (general, sleep/rest and cognitive fatigue) and a 27 item multidimensional cancer module (pain, nausea, anxiety, communication, and cognitive problems). Total score is calculated with a lower score representing a higher health related quality of life.
|
Inpatient Management Patients
Patients receiving or having received chemotherapy for AML who remain in the hospital more than 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.
HRQOL questions will be scored on a 5-point Likert response scale (0=never a problem to 4=almost always a problem). The total score includes a 23 item multidimensional core (physical, emotional, social and school functioning); an 18 item multidimensional fatigue scale (general, sleep/rest and cognitive fatigue) and a 27 item multidimensional cancer module (pain, nausea, anxiety, communication, and cognitive problems). Total score is calculated with a lower score representing a higher health related quality of life.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
94
|
|
Overall Study
COMPLETED
|
43
|
77
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Home Away From Home - Quality of Life Surveys
Baseline characteristics by cohort
| Measure |
Early Discharge Patients
n=22 Participants
Patients receiving or having received chemotherapy for AML who are discharged to outpatient management within 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.
HRQOL questions will be scored on a 5-point Likert response scale (0=never a problem to 4=almost always a problem). The total score includes a 23 item multidimensional core (physical, emotional, social and school functioning); an 18 item multidimensional fatigue scale (general, sleep/rest and cognitive fatigue) and a 27 item multidimensional cancer module (pain, nausea, anxiety, communication, and cognitive problems). Total score is calculated with a lower score representing a higher health related quality of life.
|
Inpatient Management Patients
n=75 Participants
Patients receiving or having received chemotherapy for AML who remain in the hospital more than 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.
HRQOL questions will be scored on a 5-point Likert response scale (0=never a problem to 4=almost always a problem). The total score includes a 23 item multidimensional core (physical, emotional, social and school functioning); an 18 item multidimensional fatigue scale (general, sleep/rest and cognitive fatigue) and a 27 item multidimensional cancer module (pain, nausea, anxiety, communication, and cognitive problems). Total score is calculated with a lower score representing a higher health related quality of life.
|
Total
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
22 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
10 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not recorded in EMR
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic Ethnicity · Hispanic Ethnicity
|
4 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic Ethnicity · Not Hispanic Ethnicity
|
18 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PedsQL assessments were administered at two points - at the start of the study-contributed chemotherapy course prior to the patient becoming neutropenic (baseline) and again within the period between neutropenia resolution (follow-up); follow-up reported.Population: Participants who completed evaluable PedsQL follow-up surveys.
1 Course of Chemotherapy (Approximately 30-40 days). The primary outcome of interest was patient health-related quality of life (HRQOL) measured using the acute PedsQL™ 4.0 Generic Core Scales.31 These scales use a 7-day time frame. The multidimensional assessment includes items in four domains: physical functioning, emotional functioning, social functioning, and school functioning. Respondents document responses to each question using a 5-point Likert scale anchored by never a problem (0) to almost always a problem (4). PedsQL™ items were reverse scored and linearly transformed to a scale of 0 to 100 such that higher scores reflect better HRQOL.
Outcome measures
| Measure |
Early Discharge Patients
n=22 Participants
Patients receiving or having received chemotherapy for AML who are discharged to outpatient management within 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.
|
Inpatient Management Patients
n=75 Participants
Patients receiving or having received chemotherapy for AML who remain in the hospital more than 3 days after chemotherapy completion. Subjects will complete a health related quality of life (HRQOL) survey at baseline and again at the start of the next treatment course. Survey questions will collect information such as patient race and educational level.
|
|---|---|---|
|
Compare Differences in HRQOL Scores Between Outpatient Versus Inpatient Management
|
70.1 score on a scale
Standard Deviation 18.9
|
68.7 score on a scale
Standard Deviation 19.4
|
SECONDARY outcome
Timeframe: 1 Course of Chemotherapy (Approximately 30-40 days)Information from semi-structured patient outcome surveys completed by patients and caregivers will be collected to evaluate the relationship between neutropenia management strategy (inpatient versus outpatient) and outcomes reported by patients and caregivers.
Outcome measures
Outcome data not reported
Adverse Events
Early Discharge Patients
Inpatient Management Patients
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