NCT00103285 · OUTCOME
Health-related Quality of Life Relative to Physical, Social and Emotional Impairment
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia · Source last updated 2021-06-14
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- At 1, 6 and 12 months after diagnosis and, 3 months post-therapy
What was measured
To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.Standardized scores will be computed for child function using the gender and age-adjusted scores available from normative data from a healthy population of about 10,000 children. The various domains of family functioning will be assessed using well-validated instruments and analyzed as a dichotomous variable (impaired vs. non-impaired family functioning). Multiple regression analysis will be used to test the effect of family functioning (adjusted for therapy given, age at diagnosis, gender, socioeconomic status and other factors) on child function.
Analysis population: This analysis is restricted to the 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites, who consented to and completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning).
Groups in this outcome
Induction Therapy
All patients for induction therapy.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Induction Therapy | 160 |
|---|
Reported measurements
Physical Impairment 1 mth after diagnosis
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Therapy | 76.39 | Not reported | 68.6 | 83.1 | Not reported |
|---|
Physical Impairment 6 mths after diagnosis
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Therapy | 42.75 | Not reported | 34.2 | 51.7 | Not reported |
|---|
Physical Impairment 12 mths after diagnosis
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Therapy | 29.41 | Not reported | 21.9 | 37.8 | Not reported |
|---|
Physical Impairment 3 mths post therapy
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Therapy | 27.84 | Not reported | 19.2 | 37.9 | Not reported |
|---|
Social Impairment 1 mth after diagnosis
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Therapy | 43.36 | Not reported | 35.1 | 51.9 | Not reported |
|---|
Social Impairment 6 mths after diagnosis
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Therapy | 23.66 | Not reported | 16.7 | 31.9 | Not reported |
|---|
Social Impairment 12 mths after diagnosis
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Therapy | 23.53 | Not reported | 16.7 | 31.6 | Not reported |
|---|
Social Impairment 3 mths post-therapy
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Therapy | 25.77 | Not reported | 17.4 | 35.7 | Not reported |
|---|
Emotional Impairment 1 mth after diagnosis
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Therapy | 38.89 | Not reported | 30.9 | 47.4 | Not reported |
|---|
Emotional Impairment 6 mths after diagnosis
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Therapy | 17.56 | Not reported | 11.5 | 25.2 | Not reported |
|---|
Emotional Impairment 12 mths after diagnosis
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Therapy | 13.97 | Not reported | 8.6 | 21.0 | Not reported |
|---|
Emotional Impairment 3 mths post-therapy
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Induction Therapy | 8.25 | Not reported | 3.6 | 15.6 | Not reported |
|---|
Source statistical analyses
Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.
- ci Lower Limit
- 1.61
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 16.63
- estimate Comment
- Odds Ratios in this Statistical Analysis corresponds to all four time points.
- group Description
- Physical Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Odds Ratio (OR)
- param Value
- 5.17
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 1.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.27
- estimate Comment
- Odds Ratios in this Statistical Analysis corresponds to all four time points
- group Description
- Social Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Odds Ratio (OR)
- param Value
- 1.99
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 1.03
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.34
- estimate Comment
- Odds Ratios in this Statistical Analysis corresponds to all four time points
- group Description
- Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Odds Ratio (OR)
- param Value
- 1.85
- statistical Method
- Mixed Models Analysis
Complete source fields
- analyses
- ci Lower Limit
- 1.61
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 16.63
- estimate Comment
- Odds Ratios in this Statistical Analysis corresponds to all four time points.
- group Description
- Physical Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Odds Ratio (OR)
- param Value
- 5.17
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 1.21
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.27
- estimate Comment
- Odds Ratios in this Statistical Analysis corresponds to all four time points
- group Description
- Social Functioning: Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Odds Ratio (OR)
- param Value
- 1.99
- statistical Method
- Mixed Models Analysis
- ci Lower Limit
- 1.03
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 3.34
- estimate Comment
- Odds Ratios in this Statistical Analysis corresponds to all four time points
- group Description
- Parents of 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning) and Family Assessment Device-General Functioning (FAD-GF) at 1, 6 and 12 months after diagnosis, and 3 months post-therapy.
- non Inferiority Type
- SUPERIORITY_OR_OTHER_LEGACY
- param Type
- Odds Ratio (OR)
- param Value
- 1.85
- statistical Method
- Mixed Models Analysis
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 68.6
- upper Limit
- 83.1
- value
- 76.39
- title
- Physical Impairment 1 mth after diagnosis
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.2
- upper Limit
- 51.7
- value
- 42.75
- title
- Physical Impairment 6 mths after diagnosis
- categories
- measurements
- group Id
- OG000
- lower Limit
- 21.9
- upper Limit
- 37.8
- value
- 29.41
- title
- Physical Impairment 12 mths after diagnosis
- categories
- measurements
- group Id
- OG000
- lower Limit
- 19.2
- upper Limit
- 37.9
- value
- 27.84
- title
- Physical Impairment 3 mths post therapy
- categories
- measurements
- group Id
- OG000
- lower Limit
- 35.1
- upper Limit
- 51.9
- value
- 43.36
- title
- Social Impairment 1 mth after diagnosis
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.7
- upper Limit
- 31.9
- value
- 23.66
- title
- Social Impairment 6 mths after diagnosis
- categories
- measurements
- group Id
- OG000
- lower Limit
- 16.7
- upper Limit
- 31.6
- value
- 23.53
- title
- Social Impairment 12 mths after diagnosis
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17.4
- upper Limit
- 35.7
- value
- 25.77
- title
- Social Impairment 3 mths post-therapy
- categories
- measurements
- group Id
- OG000
- lower Limit
- 30.9
- upper Limit
- 47.4
- value
- 38.89
- title
- Emotional Impairment 1 mth after diagnosis
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.5
- upper Limit
- 25.2
- value
- 17.56
- title
- Emotional Impairment 6 mths after diagnosis
- categories
- measurements
- group Id
- OG000
- lower Limit
- 8.6
- upper Limit
- 21.0
- value
- 13.97
- title
- Emotional Impairment 12 mths after diagnosis
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.6
- upper Limit
- 15.6
- value
- 8.25
- title
- Emotional Impairment 3 mths post-therapy
- description
- To identify potentially modifiable factors associated with impaired health related quality of life (HRQOL) at different periods of therapy in the patients who are SR-average enrolled on the standard risk ALL study.Standardized scores will be computed for child function using the gender and age-adjusted scores available from normative data from a healthy population of about 10,000 children. The various domains of family functioning will be assessed using well-validated instruments and analyzed as a dichotomous variable (impaired vs. non-impaired family functioning). Multiple regression analysis will be used to test the effect of family functioning (adjusted for therapy given, age at diagnosis, gender, socioeconomic status and other factors) on child function.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- All patients for induction therapy.
- id
- OG000
- title
- Induction Therapy
- param Type
- NUMBER
- population Description
- This analysis is restricted to the 160 SR-ALL patients enrolled on Children's Oncology Group (COG) therapeutic trial AALL0331 at 31 sites, who consented to and completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales (physical, emotional and social functioning).
- reporting Status
- POSTED
- time Frame
- At 1, 6 and 12 months after diagnosis and, 3 months post-therapy
- title
- Health-related Quality of Life Relative to Physical, Social and Emotional Impairment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
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